Commercial Partners 2023
Commercial Partners 2023
Adare Pharma Solutions
Adare Pharma Solutions is a global technology-driven CDMO providing end-to-end integrated services, from product development through commercial manufacturing and packaging, with small molecule expertise focusing on oral dosage forms. Our specialized technology platforms provide taste masking, controlled release, solubility enhancement, and patient-centric dosing solutions. We have developed and manufactures more than 65 products sold by customers worldwide.
We have the expertise and proven track record to guide projects from clinical research stages through optimization, validation, and approval. We operate seven facilities in the US and Europe, equipped to facilitate efficient drug product development and manufacturing, maintaining excellent environmental conditions compliant with US and EU cGMP regulations.
Adare has dedicated high potency GMP manufacturing and development areas. Our in-house regulatory and quality teams have a proven global track record, assuring our clients that products we manufacture are provided with the highest relevant standards for patient care.
To learn more, visit www.adarepharmasolutions.com or contact us at BusDevROW@adareps.com
AdhexPharma
At AdhexPharma, we are a leading CDMO (Contract Development and Manufacturing Organization) that specializes in the development and production of cutting-edge patch and oral film technologies. We understand the importance of getting your product to market quickly and efficiently, that's why we offer a full range of services to support your project from idea to market. Whether you're looking for a partner to help you develop a new product, or need a reliable contract manufacturer to bring your product to market, we have the expertise, facilities, and equipment to make it happen. In addition, we also have some out-licensing opportunities available for licensing, which can help you to expand your product portfolio and access new markets.
Did you know? Labtec, formerly known as 'tesa Labtec' is now part of AdhexPharma and specialises in the formulation and development of both patches and oral films.
Ardena
We are Ardena, a reputable contract partner delivering drug development, manufacturing, logistics and (bio)analytical services to pharmaceutical customers globally. In parallel, we work with you to compile your regulatory dossier and to fast track your product towards compliance. Every day, we guide companies through the hurdles and challenges of drug development. Our integrated service offering helps to streamline the drug's progress to clinic and beyond. Ardena is your one source contractor for the chemical and pharmaceutical development of your valued compounds. In parallel, we provide you with full product analytical and bioanalytical support during development. Our dossier-centric approach makes a difference. We work with you to compile your regulatory dossier in parallel with drug development, saving you time, identifying hurdles and fast-tracking your product to compliance. We are experts in writing and formatting supporting CMC documentation.
Asahi Kasei
Asahi Kasei is a highly diversified Japanese supplier of high-performance materials for various industries, including automotive, energy, electronics, housing and health care. In the fields of pharma- and nutraceuticals, we offer functional excipients. For many decades Asahi Kasei stands for quality, reliability and performance and is dedicated to “Creating for Tomorrow”.
Our key product is Ceolus, functional grades of microcrystalline cellulose (MCC) with outstanding compactability and flowability due to a special particle structure. This allows for avoiding typical formulation challenges like tablet mass segregation, capping, slow/fast disintegration, low tablet hardness or the changing of the API structure. Celphere, Asahi Kasei’s MCC spherical cores allow the combination of incompatible APIs in one tablet, achieve different release profiles and improve the acceptability of products. Special grades of our pregelatinized starch PC-10 can be applied for the protection of moisture sensitive APIs in the formulation.
Our functional excipients prove to be solutions to our customer’s daily challenges
www.asahi-kasei.co
www.ceolus.com/en/
Ashland
Ashland works alongside formulators to advance drug-specific delivery platforms with an industry-leading portfolio of pharmaceutical excipients and technical expertise including superior polymer technology and systems for optimum bioavailability.
For over 50 years, Ashland has created value for customers through applications knowledge, technical support, and a powerful product portfolio. The company offers real-time solutions based on superior binder, film coating, solubilizer, disintegrant, rheology control, cyclodextrins and modified-release technologies.
A team of technical experts at global R&D centers provide formulation development support for conventional and potent compounds as well as controlled substances to offer tailored solutions that address solubility challenges.
During this event, Ashland will showcase polymer solutions for extended release injectable depot strategies including ViatelTM bioresorbable polymers. This portfolio includes 72 GMP grades of lactide, glycolide and caprolactone copolymers as well as a customized polymer platform which supports formulators to solve complex processing, stability and delivery challenges.
BASF
Focusing On Your Formulation Needs
BASF produces excipients and active ingredients of outstanding quality and performance. With our unique expertise in polymer chemistry, our research & development capabilities and our clear commitment to developing excipients, BASF has continuously created solutions that contribute to your success and to more efficient pharmaceuticals. We deliver value added functional solutions to your formulation challenges by leveraging our expertise in delivery systems and related technologies. Our team of experienced industry specialists support you in developing effective, reliable formulations – giving you a vital advantage in a highly competitive market.
Our Platforms – Your Access To BASFs Solution Offer
BASF has been committed to the pharmaceutical industry since we introduced our original Kollidon® in the early 20th century. Since then we have continuously expanded our solution offer. Today we solve unmet formulation needs and offer intelligent solutions for today and tomorrow's challenges in drug formulation. Our four dedicated solution platforms based on current pharmaceutical market needs help you to find what you are looking for – faster than ever before. We can help with formulation challenges related to Instant and Modified Release, Solubilization, Skin Delivery, Softgels and Biologic Solutions
Cambridge Consultants
Cambridge Consultants develops breakthrough products, services and intellectual property, and provides business consultancy in technology-critical issues for clients worldwide. For more than 60 years, the company has been helping its clients turn business opportunities into commercial successes, whether they are launching first-to-market products, entering new markets or expanding existing markets through the introduction of new technologies.
The team of more than 800 engineers, scientists, mathematicians and designers has an unparalleled track record in creating medical technology solutions that disrupt markets and revolutionize healthcare. These range from parenteral delivery devices such as pens, autoinjectors, patch pumps and large volume injectors through to medical implants and surgical drug delivery systems. The team has also pioneered high functionality, user-centred electromechanical devices combining drug delivery with wireless connectivity and eHealth service solutions to enable patient engagement and adherence.
With offices in Cambridge (UK), Boston (USA), Tokyo (Japan) and Singapore, Cambridge Consultants offers solutions across a diverse range of industries including medical technology, industrial and consumer products, digital health, energy and wireless communications.
Captisol, a Ligand technology
Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella, University Distinguished Professor at the University of Kansas’ Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled several FDA-approved products, including Amgen’s Kyprolis®, Baxter International’s Nexterone®, Spectrum’s EVOMELA® and Melinta Therapeutics’ Baxdela™. There are many Captisol-enabled products currently in various stages of development.
Catalent
Catalent specializes in comprehensive development, analytical and bioavailability enhancement from candidate selection to fully integrated solutions, to help get customers’ drugs to clinic faster. Using a rigorous, data-driven scientific approach, API-sparing techniques and advanced formulation technologies within a global network, Catalent helps solve complex challenges to accelerate drug development.
Celanese
Celanese offers the VitalDose® Drug Delivery Platform, providing long-acting controlled release of small molecules, biologics, and nucleotides through implant and insert dosage forms. Work together with Celanese experts in our state-of-the-art feasibility lab for customized materials and service solutions tailored to your application—helping you establish proof of concept.
We are equipped to create functional API-loaded prototypes, characterize and measure in vitro drug release, and provide technical transfer support to our customers and their partners. Backed by years of experience working with global regulatory bodies, we provide customers with relevant certifications and documentation needed throughout various stages of their drug development and approval process.
With decades of experience in medical and pharmaceutical applications, our customers trust us to provide unrivaled service, world-class expertise, and quality that improve product development, enhance manufacturability, and elevate patient experiences.
Learn more about our solutions and capabilities at healthcare.celanese.com.
Conscio Group
Conscio Group is a network of European contract R&D and manufacturing service providers offering complete and innovative solutions from idea to product. Our services include the product idea, formulation and process development, manufacturing of IMPs, analytical and bioanalytical services and the production and release of registration batches. We focus on hard-to-make formulations and technologies including high potents/narcotics, transdermal delivery systems, 2D/3D printing, hot melt extrusion and spray drying. Our customers receive solutions tailored to their exact needs and due to the vast pharmaceutical and technological expertise of our teams, we can de-risk development projects and accelerate time-to-market. Headquartered in Munich, Conscio Group members include Gen-Plus (Germany), Quinta-Analytica (Czech Republic), LVA (Austria), EL Labs (Slovakia), HyServe (Germany) and a representative office in the USA.
Capabilities:
- Innovation & Formulation: Pharmaceutical R&D, feasibility, proof-of-concept, formulation and analytical method development.
- Clinical Solutions: Trials: 2 clinical units, capacity for 60+36 beds, BE/BA/PK studies.
- Clinical Solutions: Bioanalysis: GLP/GCP solutions for preclinical & clinical studies, small & large molecules, BE/BA/PK.
- Quality Control: Pharmaceuticals: GMP quality control, batch testing, stabilities, microbiology testing, HAPIs, API sourcing.
- Quality Control: Biopharmaceuticals: GLP/GMP bioanalysis, CMC, characterizations of peptide & protein IMPs, biosimilars.
- Manufacturing solutions: GMP-certified manufacturing of IMP clinical batches and commercial products.
Headquartered in Munich, Conscio Group members include Gen-Plus (Germany), Quinta-Analytica (Czech Republic), LVA (Austria), EL Labs (Slovakia), HyServe (Germany) and a representative office in the USA.
Croda Pharma
Croda Pharma is a leading partner for the development of excipients and the supply of high purity materials for pharmaceutical formulations. The company is focused on empowering biologics drug delivery, through its adjuvant systems, small molecule, protein, and nucleic acid delivery platforms. With a wide range of solutions for both human and animal health markets, the pharmaceutical portfolio is unsurpassed in its excellence. Croda Pharma’s products, along with its in-house formulation and regulatory expertise, allows the company to meet its customers’ most demanding formulation needs. The company is committed to enabling the next generation of drug delivery systems.
Curapath
Curapath’s expertise in the development and manufacturing of lipids and polymers, combined with our experience in nanoparticle formulation and manufacturing, makes Curapath the right partner for developing your therapeutic.
Curapath supports all stages of development from proof-of-concept to preclinical, clinical and commercial-scale GMP manufacturing. We help solve even the most complex drug delivery challenges. We provide unmatched technical and analytical expertise in the custom design, development, and end-to-end GMP manufacture of polymer and lipid-based drug delivery systems for cell, gene therapy, and vaccine delivery.
We deliver hands-on guidance from preclinical development through commercial-scale GMP manufacturing – a knowledgeable partner you can trust to move fast, manufacture smart, and provide support through your drug development journey, accelerating your speed to clinic.
Our product categories include:
- Polymer and Lipid Excipients
- Chemical and Biological Conjugation
- Lipid and Polymer Nanoparticle Formulation
- Aseptic Fill & Finish
DelSiTech
DelSiTech is a drug delivery and drug development company, based in Finland and is the leader in fully biodegradable, amorphous silica-based long-acting controlled release. DelSiTech's core technology, Silica Matrix, enables the delivery of virtually any API with truly controlled release over durations from a day to a year. DelSiTech Silica Matrix technology enables parenteral drug delivery through a wide variety of routes of administration, in addition to topical ocular applications of the patent protected silica composite technology. DelSiTech is currently developing controlled release products based on its Silica Matrix technology across a wide range of therapeutic areas for partners such as Bayer and the Bill & Melinda Gates Foundation
DFE Pharma
DFE Pharma is a global leader in the development, production and supply of high-quality functional excipients for use in the pharmaceutical, biopharmaceutical, and nutraceutical industries for respiratory, OSD, ophthalmic and parenteral formulations.
Our excipients play an essential role as fillers, binders, disintegrants, and in stabilizing active ingredients. With more than a century of experience and around 450 people worldwide, we serve over 5,000 customers in 100+ countries. Headquartered in Goch, Germany, DFE Pharma is committed to supporting (bio)pharmaceutical and nutraceutical companies to improve patient’s lives, driven by our purpose: Your medicines, and our solutions. Moving to a healthier world.
DSM
Royal DSM is a global, purpose-led company in Health, Nutrition & Bioscience, applying science to improve the health of people, animals and the planet. DSM’s purpose is to create brighter lives for all. DSM’s products and solutions address some of the world’s biggest challenges while simultaneously creating economic, environmental and societal value for all its stakeholders – customers, employees, shareholders, and society at large. The company was founded in 1902 and is listed on Euronext Amsterdam. More information can be found at www.dsm.com
EdgeOne Medical
Pharma knows drug development; EdgeOne Medical knows device development
Even in 2022 Pharma resources are overwhelmingly focused on drug development and continue to put a lot of pressure on a comparatively smaller but growing internal device development capability. EdgeOne Medical has been the key partner supporting eight of the top 25 Global Pharma with their device development programs and associated challenges.
Since 2012, EdgeOne Medical has been the only purpose-built and independent Contract Device Development Organization (CDDO) for Pharma that has operated proprietary ISO 13485 certified Device Testing Labs supported by Product Development, Regulatory and Quality professionals to help navigate, accelerate and, for some firms, execute Pharma Device Development Programs.
Whether your Combination Product is Drug/Device or Drug/Digital—EdgeOne Medical is the most experienced and successful partner in getting Pharma device systems compliantly on the market and stay there from Strategy to program execution. Zero 483s; 100’s of successful TMVs and Test Studies in our labs to support the Device File submission we can support or author.
EUROAPI
Euroapi is focused on reinventing active ingredient solutions to sustainably meet customers’ and patients’ needs around the world. We are a world leader in active pharmaceutical ingredients with some 200 products in our portfolio, offering a large span of technologies, while developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO).
Taking action for health by enabling access to essential therapies inspires our 3,350 people every day. With strong research and development capabilities and six manufacturing sites all located in Europe, Euroapi ensures API manufacturing of the highest quality to supply customers in more than 80 countries. EUROAPI is listed on Euronext. Find out more at www.euroapi.com
Eurofins CDMO
Eurofins CDMO is a leading global Contract Development and Manufacturing Organization (CDMO) that provides clients with Active Pharmaceutical Ingredients (APIs)/Drug Substance and Drug Product development for biologicals and small molecules. Science is our foundation and allows us to support small and major biopharmaceutical companies achieving their pre-clinical and clinical milestones on time.
We are experts in breakthrough technologies for API development, highly potent compounds, poorly soluble drugs, lyophilisation processes and specific therapeutic areas (immunotherapies, orphan drugs…).
Our services: API/DS Development, Solid State R&D, Preformulation, Formulation Development, GMP Manufacturing, Clinical Packaging and Logistics, CMC Regulatory Support.
Our highly-qualified project management team will propose a complete drug development strategy. Frequent communication through one single point of contact, our team's flexibility, troubleshooting mindset, customized solutions will help speed up the drug development process. Operating under strict quality procedures, Eurofins CDMO is accredited through the FDA, EMA, ANSM, ANSES, FAMHP, PMDA, and Health Canada.
EVEON
EVEON designs and develops custom devices for preparation and delivery of advanced therapeutic treatments. We work with practitioners and patients to provide solutions in order to improve patient compliance and therapeutic performance.
Based on more than 10 years of research, EVEON has developed a recognized expertise in microfluidics to solve preparation and delivery challenges. With more than 60% of the staff dedicated to R&D and industrialisation, we cover a complete range of skills in fluidics, mechanics, electronics, software and project management.
Evonik
Evonik is one of the world’s leading specialty chemical companies. Evonik Health Care is a leading CDMO for drug substance and drug product, advanced drug delivery solutions, including functional excipients, drug delivery technologies and CDMO services for oral and parenteral dosage forms. We also serve as a global CDMO for small molecule APIs, HPAPIs and intermediates, and supply high-quality, innovative cell culture solutions and amino acids. Evonik operates a trusted global network of manufacturing sites, laboratories and development centers around the world. We have a track record of providing enabling solutions to more than 1,000 pharmaceutical, med-tech and nutraceutical customers worldwide, including 90% of the world’s top life-science companies.
Gattefossé
Since 1880, Gattefossé has been developing, manufacturing and selling pharmaceutical excipients and cosmetic ingredients of natural origin for the health and beauty industries worldwide. Gattefossé offers to the pharmaceutical industry innovative lipid excipients for oral solubilization, bioavailability enhancement, sustained release, lubrication, and taste-masking. We provide skin penetration enhancers and emulsifiers for improved topical formulations. Every product is designed with utmost attention to safety, quality, and performance consistency. As part of Gattefossé offer, technical and regulatory support is provided by fully trained experts to accelerate customers’ drug development programs thanks to our 4 Technical Centers of Excellence in France, China, India and the United States.
Environmental and social issues have always been part of our culture. Today, Gattefossé relies on a purposeful CSR approach, Gatt’Up&Act, to build its innovation and development strategy.
Gerresheimer
Gerresheimer is the global partner for pharmaceutics, biotech, healthcare and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging and drug delivery devices. The company is an innovative solution provider from concept to delivery of the end product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence and concentration on quality and customer focus. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer psroduces close to its customers worldwide with around 10,000 employees and generates annual sales of more than €1.4 billion. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.
Glatt Pharmaceutical Services GmbH & Co. KG
Glatt Pharmaceutical Services GmbH & Co. KG is the CDMO division of the Glatt Group. We develop solid pharmaceutical dosage forms with a focus on multiparticulate systems, such as pellets, granules, tablets, and capsules. We offer innovative solutions to achieve drug solubility enhancement by amorphous solid dispersions. Functional coating for taste masking and controlled drug release is another key expertise at our sites Binzen, Germany and Ramsey, New Jersey.
Our service portfolio covers the full range from feasibility studies and the formulation development over the production of clinical samples up to the bulk manufacturing of pharmaceuticals. The storage, commissioning, as well as the distribution organization of clinical samples and pharmaceuticals for market supply complete our service portfolio. In this sector, we also offer additional logistic services for import, export, and cold chain management.
Hovione
Hovione offers customized services and innovative solutions from drug substance to drug product, with all activities performed at the same site. Hovione provides a fully integrated service for clinical and small commercial scale complex drug product development and manufacturing as well as formulation development for highly sophisticated inhalation and other formulations both for small molecules and biologics. As the Leader in Commercial Spray Drying, Hovione can handle projects from early-phase development to commercial and accelerates your time to market. Our particle engineering technologies can address challenges in solubility enhancement, lung delivery, modified release and taste-masking applications and can handle highly potent compounds. For biopharmaceuticals Hovione is investing by partnering in specialized particle engineering technologies, namely spray drying, aseptic spray freeze drying, nanoparticles and microemulsions. We do well what is difficult, to give our customers what they cannot find elsewhere
IMCD
IMCD is a leading distributor, formulator, and solutions provider of speciality chemicals and ingredients.
We deliver innovation for a healthier world by providing materials and excipients with a secure and traceable supply chain, as well as technical support to help our customers in their operational and technological challenges.
Whether you need a product for your upstream or downstream process, IMCD is the ideal partner to source your ingredients. Through our collaborations with leading suppliers, our portfolio meets even the most stringent purity criteria.
We offer products used at every stage of the bio-production process:
- Upstream
- Downstream
- Formulation
This includes ingredients with multi-compendial compliance, low bioburden and low endotoxin values. Our portfolio includes solutions with API-level documentation, as well as simpler variants.
Innocore Pharmaceuticals
InnoCore Pharmaceuticals is a biopharmaceutical drug delivery company specialized in the development of long-acting injectables (LAI) for the treatment of several (chronic) diseases e.g. oncology, pain, atherosclerosis, macular degeneration, CV, osteoarthritis. Using biodegradable polymers for microspheres, gels and implants (including ISFI) we have a unique platform to control sustained drug delivery of small molecules, peptides and proteins (including mAbs) from days, weeks to months (6).
KNAUER
Based on 60 years of experience in the development and manufacturing of scientific instruments, KNAUER also offers custom engineering of equipment for the laboratory and for GMP production.
The company’s most recent development in this field – lipid nanoparticles (LNP) production systems – have enabled the large-scale manufacturing of mRNA-based vaccines to fight the Corona pandemic.
Traditionally, KNAUER is best known for its high-precision liquid chromatography systems (HPLC and FPLC) and related components. The systems are used to analyze samples for ingredients and impurities and determine their quantities, both in the laboratory and in process analysis. The systems can also purify value substances such as active pharmaceutical ingredients on a laboratory scale.
KNAUER’s valves, pumps, detectors, and other components are also used for tasks such as high-pressure dosing and various flow detection tasks in different applications. OEM manufacturing LC components for other suppliers is an important part of KNAUER’s business.
Lonza
Lonza is a preferred global partner to the pharmaceutical, biotech and nutrition markets. We work to enable a healthier world by supporting our customers to deliver new and innovative medicines that help treat a wide range of diseases. We achieve this by combining technological insight with world-class manufacturing, scientific expertise and process excellence. Our unparalleled breadth of offerings enables our customers to commercialize their discoveries and innovations in the healthcare industry.
Founded in 1897 in the Swiss Alps, today, Lonza operates across five continents. With more than 17,000 employees (full-time equivalent), we comprise high-performing teams and individual talent who make a meaningful difference to our own business, as well as to the communities in which we operate. The company generated sales of CHF 3 billion with a CORE EBITDA of CHF 987 million in H1 2022. Find out more at www.lonza.com
Follow @Lonza on LinkedIn
Follow @LonzaGroup on Twitter
LTS Lohmann
LTS LOHMANN Therapie-Systeme AG is a leading pharmaceutical technology company that develops and manufactures innovative drug delivery systems such as Transdermal Patches (“TTS”) and Oral Thin Films (“OTF”) for the pharmaceutical industry. LTS´ commercial offering encompasses more than 20 marketed products and a diverse pipeline of more than 30 development projects targeting multiple disease indications. LTS’s innovation pipeline contains both partner-funded as well as proprietary, LTS-funded projects. LTS maintains its leading position through the continuous refinement of its core TTS and OTF technologies and by advancing emerging drug delivery technologies, including Micro Array Patches (MAP) for the transdermal delivery of large molecule, biological actives and vaccines. Founded in 1984, LTS operates today from three sites: in Andernach, Germany, West Caldwell, NJ, USA and St. Paul, MN, USA. LTS has also a representative office in Shanghai, China.
Lubrizol Life Science Health
Lubrizol Life Science – Health partners with medical device, pharmaceutical and nutraceutical companies to develop innovative solutions that improve patient outcomes and consumer benefits.
As an integrated solution provider, we co-develop solutions with our customers from concept to commercialization. Along with our best-in-class medical polymers, pharmaceutical excipients, and nutraceutical actives, we offer our design & development expertise, and advanced global manufacturing capabilities to enable your development and to accelerate your innovations to market.
Marinomed Biotech AG
Marinomed Biotech AG is an Austrian Biotech company specializing in the development of innovative products based on its IP protected technology platforms. Under the brand Solv4U, Marinomed provides Marinosolv® formulation development in technology partnerships for active ingredients.
Marinosolv® is based on micelles and enables the solubilization and thereby bioavailability of hardly soluble small molecules and peptides in aqueous formulations. Consequently, new treatments of a multitude of diseases can be envisaged. Marinosolv® technology facilitates efficient drug delivery with a low systemic off-target activity. It has been clinically demonstrated that Marinosolv® allows a pronounced dosage reduction with an improved therapeutic effect suggesting a more sustainable treatment compared to existing options.
Midas Pharma
One Partner - many Opportunities. Midas Pharma is a mid-sized pharmaceutical company, founded 1988 and based in Ingelheim, Germany. Midas offers products, services and expertise along the entire pharmaceutical value chain - from Starting Materials and Active Pharmaceutical Ingredients to the development of market-ready Finished Products and Medical Devices and being marketing authorization holder for medicaments. Since over three decades the family-owned company has successfully contributed to the Pharma sector and has step by step expanded its competencies. With more than 270 employees and 10 locations in all major pharmaceutical markets worldwide Midas Pharma has excellent local know-how, local contacts and well-established networks in different pharmaceutical sectors. Visit Midas Pharma at the DDF Event and www.midas-pharma.com
Munit SA
MUNIT and its affiliates JETPHARMA and MICROCHEM operates in the field of MICRONIZATION and MILLING of Active Pharmaceutical Ingredients (APIs), High-Potent-APIs, Cytotoxic- and Cytostatic- compounds, Inhalation products, Steroids, R&D compounds and Generics.
Our services:
- Jet- , Pin- and Hammer milling
- Cryogenic-Micronization
- Co-Micronization
- Post-milling conditioning
- Sieving, Blending, De-Lumping
- Technical trials, DoE Studies, Process-development and Validation
- QbD
- PSD analysis etc.
The triangular company structure with its back-up potential, its technology transfer and the resulting flexibility is one of our unique features in the market (Business continuity).
MUNIT guarantees best service, high efficiency and punctuality to customers worldwide.
Nanexa
Nanexa’s vison is to be a world leading drug development company for Long Acting Injectables, developing a new generation of innovative drug products enabled by our unique PharmaShell® technology.
In its state-of-the-art pilot plant and labs in Uppsala, Nanexa runs the development of own product projects and collaborative projects with other pharmaceutical companies, based on the PharmaShell® system. Nanexa are pioneers in bringing the control, precision and versatility of Atomic Layer Deposition (ALD) technology to drug formulation.
Founded in 2007 by two postdoctoral researchers from the University of Uppsala determined to discover new capabilities for ALD beyond industrial electronics, Nanexa now has its first Phase I clinical study underway and is developing the world’s first GMP pharma manufacturing plant with industrial Atomic Layer Deposition capabilities.
Nanoform
Nanoform is an innovative nanoparticle medicine-enabling company that works together with global Pharma and biotech partners to devise solutions to complex formulation challenges. Nanoform’s multi-patented and scalable Controlled Expansion of Supercritical Solutions (CESS®) process can produce uniform nanoparticles as small as 10nm, facilitating transport even across biological barriers. As particles smaller than 100nm have significantly enhanced surface areas, this can increase drug dissolution rates and improve bioavailability, allowing drugs of poor solubility in the pharmaceutical pipeline to progress to clinical development. CESS® enables lower dosage and safer products to be developed with reduced side-effects and permits combination therapies, which would otherwise be prohibited by the large dosages of either drug. The award-winning technology is also ushering in a new era of ocular, pulmonary and transdermal drug delivery applications, along with enhanced delivery of drug particles across the blood-brain barrier.
NOF CORPORATION
NOF CORPORATION, the leading commercial supplier of drug delivery products through R&D to commercial scale, provides activated PEGs for protein modification, single molecular PEGs for ADCs, Polysorbate 80 for formulation of biological medicines, PEG lipids and ionizable lipids for lipid nanoparticle (LNP) formulations. NOF's LNP platform composed of COATSOME® SS Series, novel biodegradable ionizable lipid, demonstrates superior endosomal escape and provides high protein expression with extremely low systemic toxicity. The platform can be applied to gene delivery, gene editing, nucleic acid vaccine and in vitro transfection. It is capable of encapsulating pDNA, siRNA and mRNA, and delivering these to various organs and tissues. NOF’s LNP platform is becoming adopted in clinical planning by NOF collaborators.
Pfanstiehl Inc.
Pfanstiehl Inc. is a cGMP Manufacturer of High Purity Low Endotoxin components such as Trehalose, Sucrose, Mannitol, Maltose, Galactose (non-animal), Mannose and Amino Acids such as L-Arginine, Histidine, Glutamine and Methionine for Biologics, Biosimilars, Vaccines, Cell Culture Media and Injectables (liquid & lyo) located in Waukegan Illinois USA. Pfanstiehl has been in operation since 1919, focusing on both Biopharmaceutical excipients / critical components & Pharmaceutical HPAPIs / APIs (generic and on contract manufacturing base). Pfanstiehl specializes in isolation, purification, custom synthesis and scale-up development of regulated, high purity and low endotoxin Injectable Formulation Ingredients, Pharmaceutical Intermediates and Active Pharmaceutical Ingredients, in gram to multi-ton commercial quantities.
Pion
Pion Inc. is the leading provider of tools and analytical instruments that bridge the gap between in vitro experiments and in vivo outcomes. The instruments help companies confidently decide which drug substances and drug products to progress through the development pipeline while helping to optimize process parameters along the way. Pharmaceutical and biopharmaceutical users benefit from richer, more relevant insights about product behavior and ideal formulation conditions. With a 20+ year heritage, Pion serves global markets with local offices globally, headquartered in the US.
PMC Isochem
PMC Isochem offers contract research, custom manufacturing, catalogue products and innovative solutions for Pharmaceutical companies worldwide. Our offer addresses three major areas:
- Drug delivery vehicles: TPGS-1000 NF USP for poorly soluble drug formulation and Polypeptides based solution for Nano Encapsulation and Polymer Drug Conjugates
- CDMO services: GMP industrial exclusive custom synthesis and provides tailor made services from development to production. 3 FDA audited manufacturing plants
- Generic APIs: 20 generic API for US, EU and worldwide market
Powder Systems Limited (PSL)
Recognised for our expertise in pharmaceutical and chemical processing, Powder Systems Limited (PSL) provides a full range of solid liquid separation solutions for filtration, drying, and processing. Our products are scalable, from early R&D, clinical trials, pilot plant activity, up to larger commercial production.
PSL’s flagship process technology, the MicroSphere Refiner (MSR™), is transforming the way polymeric microsphere drugs are developed and manufactured. It enables pharmaceutical manufacturers to improve their processes and adopt the latest advances to produce their medicines in a safer, better and more cost-effective way, benefiting millions of patients around the world.
We strive to meet the ever-changing needs of our customers and partners through our commitment to providing innovative, quality products and services, in line with regulatory requirements such as ISO 9001:2015.
We are proud of our award-winning track record and have been working with industry partners for over 30 years.
Precision NanoSystems
Precision NanoSystems is a global leader in technologies, solutions and services for the development of non-viral delivery of genomic medicines, including mRNA vaccines and therapeutics.
ProDigest
ProDigest is a dynamic CRO offering the best-in-class in vitro simulations of the gastrointestinal tract. Capitalizing on almost fifteen years of competence in gastrointestinal biology and superior bioengineering skills, in 2021 we have patented the Diamod®, the dynamic intestinal absorption model, which is the most biorelevant simulator of the upper GIT for studying drug dissolution and permeation.
Diamod®, that we operate on behalf of customers on a fee-for-service basis, recreates the physical connection between the two processes of dissolution and permeation, reproduces all the dynamics present in the stomach and small intestine, and delivers pharmacokinetics data (Cmax, Tmax and AUC) showing an in-vitro-in-vivo-correlation up to 99%. Being the system able to distinguish molecular from apparent solubility it is the tool of choice for the development of formulations especially for BCS-II compounds.
Quotient Sciences
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients.
Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, molecules need to become cures, fast. Because humanity needs solutions, fast.
Roncadelle
We make drug injection safer & keeping people safe from infections!
Roncadelle Operations is committed to increasing the safety of drug injections and improving the protection of patients and healthcare workers. We are dedicated to reducing the spread of infectious diseases and promoting safer healthcare.
Our product portfolio includes a range of patented safety syringes and needle protection systems for pre-filled syringes and cartridges. They are easy to use, offer good value for money and meet current and increasingly stringent regulatory and legal requirements.
As a drug delivery device and packaging specialist, we also offer value-added services from design to commercialization with scale-up manufacturing solutions. Our services range from customized user-centered design, feasibility studies and prototyping to high-end manufacturing and packaging solutions. This reflects our commitment to excellence in healthcare and medical technology.
From the heart of Europe, Roncadelle Operations offers design expertise and state-of-the-art cleanroom production capabilities next door to our clients in the pharmaceutical and healthcare industries.
We are happy to service your needs! Let’s talk.
Roquette
Roquette is a global leader in plant-based ingredients, a pioneer of plant proteins and a leading provider of pharmaceutical excipients. In collaboration with its customers and partners, the group addresses current and future societal challenges by unlocking the potential of nature to offer the best ingredients for food, nutrition and health markets.
These ingredients respond to unique and essential needs, enable healthier lifestyles and are critical components of life-saving medicines.
Thanks to a constant drive for innovation and a long-term vision, the group is committed to improving the well-being of millions of people all over the world while taking care of resources and territories.
Roquette currently operates in over 100 countries, has a turnover of around 3.7 billion euros and employs 8,670 people worldwide.
Samsung Biologics
Samsung Biologics is a fully integrated CDMO partner, providing tailored solutions to clients. We offer end-to-end services from cell-line development to final aseptic fill/finish for biologics. Our plants are cGMP compliant, expecting to hold 604KL with a wide range of bioreactor scales upon completion of Plant 4.
Schrödinger
Schrödinger is transforming the way therapeutics and materials are discovered. Schrödinger has pioneered a physics-based software platform that enables discovery of high-quality, novel molecules for drug development and materials applications more rapidly and at lower cost compared to traditional methods. The software platform is used by biopharmaceutical and industrial companies, academic institutions, and government laboratories around the world. Schrödinger’s multidisciplinary drug discovery team also leverages the software platform to advance collaborative programs and its own pipeline of novel therapeutics to address unmet medical needs.
Founded in 1990, Schrödinger has over 650 employees and is engaged with customers and collaborators in more than 70 countries. To learn more, visit www.schrodinger.com, follow us on LinkedIn, or visit our blog, Extrapolations.com.
Seppic
Seppic, an Air Liquide Healthcare company, has been a subsidiary of the Air Liquide Group since 1986. For over 75 years, Seppic has developed, manufactured, and marketed unique ingredients for cosmetic, nutraceutical, pharmaceutical, veterinary, and industrial products. Across the world, Seppic has created a vast team of women and men who love what they do in service to their customers, and to the health, well-being, and beauty of all.
As an expert in surfactants, polymers, and formulation, Seppic offers pharmaceutical excipients adapted to oral, topical, and parenteral routes of administration. Its ingredients range from film coatings for tablets to injectable solubilizers and polymers for dermopharmacy. For over 25 years, Seppic has also offered high-performance adjuvants for therapeutic vaccines. Now, our work has expanded to involvement in prophylactic vaccines.
SEQENS
SEQENS is a worldwide leader in the development and production of active ingredients, pharmaceutical intermediates, specialty ingredients and cosmetics & personal care leveraging 24 manufacturing sites, 10 R&D centers and 3,400 employees in 10 countries.
SEQENS provides key expertise and capabilities in Drug Delivery Solutions for:
- RNA/DNA vectorization for the vaccines, oncology, etc.
- Materials for medical devices
- Bioavailability improvement (controlled-release, solubility enhancer, liposome)
Sever Pharma Solutions
QPharma, Foster Delivery Science and Disphar International are now Sever Pharma Solutions. Together we have formed a new CDMO, a company that can provide our customers with unique capabilities and expertise. Sever Pharma Solutions brings your pharmaceutical ideas to life by offering expertise in high potent drug development, a drive to enhance performance, a passion for perfection, and a commitment to be your partner through the whole journey. We can enhance your reach by ensuring that your products can benefit patients all over the world. We can enhance your efficiency by providing you with a complete value chain to offer you an optimized end-to-end solution. We can enhance your product by adding value through all development and manufacturing processes. We can enhance your outcome by adding value through all development and manufacturing processes. We are Extrusion. We are Polymer Based Dosage Forms. We are Formulation of Highly Active dosage forms. We are Long Acting Implants. We are Solid Dosage Forms. We are Injection Molding. We are Aseptic Fill and Finish. We are Sever Pharma Solutions.
SGS Quay Pharma
SGS Quay Pharma is experienced in providing a comprehensive out-sourcing service for formulation and analytical development with subsequent clinical trials and commercial manufacturing for pharmaceutical and biotechnology companies world-wide.
Working as a dedicated, pro-active part of your team we apply strong project management and technical expertise to take products quickly and cost effectively from late stage preclinical through to the end of phase III clinical trials and commercial manufacturing.
SGS Quay Pharma has vast expertise in dosage form design and development. We have built a reputation for specialising in the formulation of API’s that exhibit poor solubility and bio-availability and those which require modified or controlled release.
ShinEtsu Tylose GmbH & Co KG
SE Tylose is the distribution organization of Shin-Etsu Chemical Co., Ltd. Japan and SE Tylose, Wiesbaden Germany and is registered in Wiesbaden. It is located at the Industrial Park Kalle-Albert in Wiesbaden. Together with our distributors, we are the exclusive business partners for our customers and multi national key accounts in the pharmaceutical- and the food industry. SE Tylose manages a regional, centralized warehouse for all products to be able to supply the customers in Europe on short-term base whenever necessary. SE Tylose will manage logistic for customers in other regions independent from Shin-Etsu´s production sites. For our pharma customers we offer with our technical application lab the possibility to optimize their processes if required. Our products are covering a very wide range of applications and they fully comply with FDA, USP/NF, JP and EP requirements. Pharmaceutical Excipients: Cellulose ether excipient is a pharmacologically inactive substance used as a carrier for the active ingredients in medication. PHARMACOAT® – Water-Soluble Film Coating Agent METOLOSE® – Binder and Thickening Agent METOLOSE® SR – Sustained release agent for hydrophilic matrix system L-HPC – Disintegrant with Binding Properties, Multifunctional Excipient HPMCP – Enteric Coating Agent Shin-Etsu AQOAT® – Enteric Coating Agent, Solid Dispersion Polymer Tylopur® – Low- and high viscosity Hypromellose
Sonceboz
Sonceboz, a Swiss technology company, leader in the design and manufacture of mechatronic solutions. From idea to motion, our goal is to create innovative, reliable, safe and environmentally friendly systems. We help our pharmaceutical and medical customers make life easier for patients and improve treatment outcomes through innovative, reliable and cost-effective wearable medical devices. We innovate by drawing on our expertise and heritage in electronics, drive systems, digitalization to create reliable and easy-to-use medical devices such as portable body injectors. The growing importance of bio-medicines such as monoclonal antibodies, associated with the need for more effective care, justifies new administration technologies that allow to decentralize care for increased comfort of the patient and caregivers. Our OBI platform is the perfect way to administer up to 20 ml and more subcutaneously. This versatile platform works with your primary container, whether it is a standard or a custom-sized cartridge. It allows for strong personalization. Our business model is partnership-oriented.
Syntegon
Processing and packaging for a better life – this is what 5,800 Syntegon employees work for every day. Be it with individual machines, systems, or services, we help you – our customers in the global pharmaceutical and food industries – to improve people's lives. For that we look back on more than 160 years of experience. In the pharma sector, our intelligent solutions enable the safe and high-quality production, processing, filling, inspection, and packaging of your liquid and solid pharmaceuticals. In the food industry, our flexible and reliable technologies produce and package confectionery, dry food, frozen food, and dairy products. With 1,100 service experts and a comprehensive service portfolio throughout the entire machine lifecycle from spare parts management to digital line optimization, Syntegon lays the foundation for your smooth production processes. In everything we do, our more than 30 sites in almost 20 countries keep a firm eye on our impact on the environment and society. Syntegon is a leader in the development of sustainable packaging solutions, reduces the energy consumption of its machines and pursues ambitious goals to lower its emissions.
The TIM Company
The TIM company is a CRO company providing a wide range of services using the most advanced dynamic in vitro models of the gastrointestinal tract. By simulating the complex luminal environment of the human GI tract, the TIM technology enables thorough insights and guidance to inform strategic decision making in the drug development process.
From formulation ranking to food-drug and drug-drug interaction investigations, we offer valuable services to accelerate the development timeline of pharmaceutical companies.
Proven to decrease the number of development iterations, TIM Studies effectively de-risk clinical trials and shorten time-to-market. As a recognized alternative to preclinical dog models, TIM studies also inevitably reduce the need for animal experiments.
WuXi STA, a subsidiary of WuXi AppTec
WuXi STA, a subsidiary of WuXi AppTec, is a leading CRDMO providing integrated CMC services including both API and drug product for small molecule, oligonucleotide, peptide and complex conjugate from discovery to development and commercial manufacturing.
WuXi STA has 14 R&D and manufacturing sites across Asia, North America and Europe. Our comprehensive drug product platform has a strong R&D team of 1,500+ scientists with capabilities in broad oral and parenteral dosage forms. Our bioavailability enhancement technology platform includes spray-dried dispersion, hot melt extrusion, nano suspension, softgel & liquid filled hard capsules.
Yirdoc
Yirdoc is a leading provider of customized mesh nebulizers for inhalation delivery needs. Our patented nebulizer design, mesh technology, and digital platform are designed to improve clinical results and formulation development by increasing the total dose delivered. As a trusted partner to pharmaceutical and biopharmaceutical companies, Yirdoc helps its clients achieve their goals by providing innovative and cost-effective solutions that meet their specific needs. Whether you're looking to improve drug delivery or optimize formulation development, Yirdoc has the expertise and technology to help you succeed.
Zerion
Zerion Pharma A/S is a pharmaceutical company aspiring to transform the pharmaceutical landscape for the formulation of poorly soluble drugs that are currently not reaching their therapeutic potential.
The company was established in 2019 as a spinout from the University of Copenhagen based on a decade of research. Zerion Pharma has pioneered the Dispersome® technology that greatly enhances the solubility of poorly soluble, oral drugs and improves bioavailability and therapeutic options for patients.
The Dispersome® technology is based around a class of novel excipient, namely beta-lactoglobulin (BLG), to formulate poorly soluble small molecule drugs into stable amorphous drug delivery systems with a high drug load. By increasing solubility and dissolution rate, the Dispersome® platform aims at improving bioavailability and therapeutic outcomes and reducing adverse effects in patients. The Dispersome® technology is well accepted with no safety risks and is compatible with standard solid oral dosage form manufacturing.