Commercial Partners
Commercial Partners 2022
3P Innovation
3P innovation is an award-winning engineering and custom automation company. They work collaboratively with pharmaceutical and medical device businesses to help develop new products, devices and production processes.
3P’s pharma equipment brand supports customers’ full product lifecycle: from initial drug development activities, through clinical stage manufacturing and onto commercial scale production.
Featuring across their Discover, Explore and Evolve ranges 3P’s Fill2Weight Technology handles and fills the most challenging powders and is the world’s fastest gravimetric powder micro-dosing technology.
To explore 3P innovation’s technologies in hyper-realistic 3D, visit their virtual showroom: https://www.3pinnovation.com/media-events/virtual-showroom
Adare Pharma Solutions
Adare Pharma Solutions is a global technology-driven specialty CDMO providing turnkey product development through commercial manufacturing expertise focused on oral dosage forms for the Pharmaceutical, Animal Health and OTC markets. Adare’s technology platforms specialize in ODT, taste masking and customized drug release.
With over 30 years of proven legacy, Adare has successfully developed and manufactured more than 40 products sold by customers in more than 100 countries globally.
Amneal
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals, primarily within the United States. The Company has a diverse portfolio of approximately 250 products in its Generics segment and is expanding across a broad range of complex products and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceutical products focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets.
Aragen
Aragen Life Sciences is a leading R&D and manufacturing solutions provider for the life sciences industries worldwide. Aragen offers end-to-end integrated or standalone solutions to advance small and large molecule programs from concept to commercialization. Established in 2001, the Company operates through a global network of six sites with a team of 3800+ employees and 450+ PhDs. Its expertise and experience have enabled over 450 customers (including 7 of the top 10 pharma companies globally) in advancing their research programs from early discovery through development and commercialization. Aragen’s innovative mindset, infrastructure, flexible business models, a clear purpose, and proprietary project management platform have enabled it to effectively scale and service large pharma, biotech, agrochemical, and animal health industries globally.
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.
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.
Bachem
Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange.
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
BDD Pharma
For more than 20 years BDD have developed and grown a world leading platform of expertise in biopharmaceutics and oral drug formulation development. Through the undertaking of clinical trials in which we have visualised the performance of products, we are able to identify and anticipate drug delivery challenges and apply this knowledge to our formulation development from an early stage. This ensures our clients take a reliable path to commercial success.
BDD helps our clients through providing crucial data for decisions through our clinical unit offering gamma scintigraphy studies and adaptive clinical trials. Our patented controlled drug release platform, OralogiK™ allows for customizable tablets for specific drug release designed with the end patient group in mind to enhance quality of life and compliance.
Our client base covers the globe, including USA, Canada, Europe, Japan, India, and Australia. Supporting businesses from virtual labs to small, medium and key global players.
BENEO
BENEO is part of the Südzucker Group and a member of the International Pharmaceutical Excipient Council (IPEC). BENEO produces galenIQ™ (Isomalt Ph.Eur., JP, USP-NF), a multifunctional range of water soluble filler-binders according to cGMP conditions for pharmaceutical excipients. galenIQ™ is available in a wide variety of median particle sizes, morphologies and solubilites and therefore is readily used in solid and liquid dosage forms such as tablets, sachets, effervescents, lozenges and syrups. galenIQ™ is physically and chemically stable, non-hygroscopic and enhances the palatability of the final form.
Calusa bio
Calusa Bio has developed a novel excipient to minimize protein aggregation in biologic drug products. Protein aggregation is a concern during throughout the manufacturing and use of current biological drug products that can impact shelf-life, drug performance, and patient safety. Existing surfactants, including polysorbates, offer improvement, but introduce new concerns related to the PEG-based excipient. Our solution is free of PEG and improves the stability of proteins in a variety of stressed conditions when compared to polysorbates. This polysarcosine based excipient offers a marked improved solution to attenuate aggregation in these highly-valuable protein drug products.
Cambridge Consultants
Cambridge Consultants develops breakthrough products, creates and licenses intellectual property, and provides business consultancy in technology-critical issues for clients worldwide. For more than 50 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 850 staff, including engineers, scientists, mathematicians and designers have 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) and Singapore, we have supported many of the market-leading biotech, pharmaceuticals and medical robotics companies.
CAS
CAS, a division of the American Chemical Society specializing in scientific information solutions, partners with R&D organizations globally to provide actionable insights that help them plan, innovate, protect their innovations, and predict how new markets and opportunities will evolve. Scientific researchers, patent professionals and business leaders around the world across commercial, academic and government sectors rely on our solutions and services to advise discovery and strategy. Leverage our unparalleled content, specialized technology, and unmatched human expertise to customize solutions that will give your organization an information advantage. With more than 110 years' experience, no one knows more about scientific information than CAS.
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, or visit us during the event at booth #20.
confinis
confinis is a global consulting firm in the field of medical devices, combination products, and in vitro diagnostics based in Switzerland, the USA, and the UK. Our range of services includes regulatory affairs, quality management, design control, risk management, usability engineering/human factors, clinical affairs, labelling, manufacturing, process validation, supply chain, post-market monitoring, auditing, and training. Our experienced and highly motivated team consists of electrical, mechanical, software, and biomedical engineers, as well as physicists, pharmacists, medical doctors, chemists, biochemists, biologists, microbiologists, and biotechnologists.
We have mastered the theory, but we still see ourselves as practitioners who have learned from scratch. Our knowledge and skills, based on theoretical foundations, are rounded off with years of practical experience. As a partner, confinis offers its clients pragmatic and workable solutions.
Corbion
Corbion is a leading resorbable polymers supplier for medical implant device manufacturers and drug delivery formulations. We empower customers to grow by working side by side with you in making conscious choices in medical applications and inspiring to create patient friendly solutions with reduced healthcare costs to help improve patients’ lives.
Corbion Biomaterials develops, manufactures and markets lactide and glycolide monomers and resorbable (co)polymers based on lactide, glycolide and caprolactone worldwide under the PURASORB® brand name. These polymers can be manufactured with any of the lactide isomers (L, D or DL). You can start your project assured that our polymers have already proven themselves as they are used extensively in pharmaceutical applications and controlled drug delivery systems. We support your developments with our products from early stage R&D to commercial manufacturing.
We invite you to contact us and find out how our 40+ years of experience can be of value to your business.
Croda Health Care
Smart science to improve lives™
Croda Health Care offers high purity pharmaceutical excipients, highly performing vaccine adjuvants and in-house formulation expertise, making them the ideal solutions provider with whom to navigate drug and vaccine formulation challenges. The product portfolio is proven to solubilise, stabilise and deliver the most challenging of active pharmaceutical ingredients, while high investment in GMP and multi-site EXCiPACT accreditation demonstrates confidence in both excipient quality and supply chain security.
Established in 1925, Croda is the name behind high performance ingredients and technologies in some of the world’s biggest and most successful brands: creating, making and selling speciality chemicals that are relied on by industries and consumers everywhere. With a network of over 4,500 passionate and committed employees, Croda works together as one global team across manufacturing sites and offices in 38 countries.
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 pharma- and nutraceutical excipient solutions. We strive to develop, produce and supply the highest quality functional excipients for use in the pharmaceutical, biopharmaceutical and nutraceutical industries for respiratory, oral solid dose (OSD), ophthalmic and parenteral formulations. Our excipients are used in numerous medicinal and nutraceutical products, including COVID-19 vaccines and - treatments.
Our excipients play an essential role as fillers, binders, disintegrants, and in stabilizing active ingredients for release in a predictable and effective manner into the patient’s system. With more than a century of experience and around 450 people worldwide, we are serving over 5,000 customers in 100+ countries worldwide. Headquartered in Goch, Germany, DFE Pharma is committed to supporting (bio)pharmaceutical and nutraceutical companies in their journey to improve patients’ lives, driven by our purpose: Your medicines, our solutions. Moving to a healthier world.
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.
EVEON
EVEON transforms the patient experience with technological, digital and user innovation products and services to improve the handling, preparation (lyo, dilution, liquid-liquid,...) and administration (injection, infusion, spraying, nebulization,...) of specific drugs. Our native digital platform enables tracking and connected features beyond the core disposable fluidic features. We develop and manufacture custom product for pharmaceutical, biotech companies and medical device manufacturers from prototype to production under ISO-13485 standards.
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.
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.
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 global leader in the distribution 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
IInnoCore 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).
Intertek
Intertek Melbourn has specialist skills and experience in analytical testing and formulation for both small molecule and biologic orally inhaled and nasal drug products (OINDP), alongside all other pharmaceutical dosage forms. With 30 years of experience in supporting our clients’ product developments, we deliver world-class support for method development / validation, analytical testing, stability programs, CMC studies, formulation development and clinical manufacturing from our facility located in Melbourn, near Cambridge, UK. Our team of scientists have a reputation for providing outstanding and responsive customer service. Through our expertise in analytical and formulation development, we help our clients in the pharmaceutical, biotechnology and drug delivery industries to meet milestones for their challenging pharmaceutical development programmes. The laboratory is inspected and approved by the UK Medicines & Healthcare Products Regulatory Agency (MHRA) for GMP compliance. The Laboratory has also been inspected by the US Food and Drug Administration (FDA) against GMP as part of clients’ pre-approval inspections. Our services include:
• Method Development / Validation
• Analytical Testing
• Formulation Development
• Device Screening
• Quality by Design (QbD) Studies
• ICH and Accelerated Stability Studies
• Clinical Trials Materials Manufacturing
• Product Characterisation Studies
• In-Vitro Bioequivalence Studies for Generic Products
Lipoid
The Ludwigshafen-based Lipoid Group is the world’s only supplier to produce a complete range of high-purity natural, hydrogenated, and synthetic phospholipids.
Naturally derived raw materials and environmentally friendly processes are the predominant basis of our wide range of products.
As a global player with close to 500 employees and a world-wide distribution organization, the Lipoid Group has become world leader in the field of phospholipids for pharmaceutical applications.
Lipoid’s phospholipids provide an essential basis for sophisticated drug delivery systems, such as emulsions, liposomes, mixed micelles, and lipid nanoparticles, particularly for parenteral applications. These systems play a crucial role, for example, in tumor therapeutics and drugs for inhalation. Moreover, Lipoid’s products are also components in many vaccine systems. Of particular current prominence is Lipoid’s contribution to Covid-19 mRNA vaccines and vaccines containing adjuvants.
In addition, phospholipids from Lipoid have applications in dietary supplements and in high-quality cosmetic products.
Lonza
At Lonza Pharma & Biotech, we provide contract development and manufacturing services that enable pharma and biotech companies to bring medicines to patients in need. From the building blocks of life to the final drug product, our solutions are created to simplify your outsourcing experience and provide a reliable outcome, at the time when you expect it. Our extensive track record includes commercialization of pioneering therapies and manufacturing of a wide variety of biological and chemical drugs. We continuously invest to solve not just current, but also future challenges. Together, we can bring your next medicine to life.
LTS Lohmann
LTS is the global leader in the development and manufacture of transdermal systems and oral thin films with additional innovative technologies in development. The products developed by LTS comprise a multitude of innovations, such as first and only patch for treatment of Alzheimer and the only patch against Parkinson’s and Restless-Legs-Syndrome, which is the first medication in the world available only as a patch. The innovation capability of LTS led the way for oral thin film products on the market with the introduction of Listerine® Pocketpaks®, which dominate the North American market. LTS supports its cooperation partners from product inception through commercialization in our FDA approved facilities in Germany and USA. More than 3,000 patents reinforce the top position of LTS group in development of its technologies. LTS Lohmann services include: Feasibility studies Full product development Clinical studies phase I-IV Scale-up and process development Commercial manufacturing For transdermal therapeutic systems, topical patches and oral thin films (OTF)
Lubrizol Life Science Health
The Health business team at Lubrizol Life Science partners with customers to speed their innovative medical devices and differentiated pharmaceutical products to market. Our dedicated team provides best-in-class polymers and excipients, along with state-of-the-art product design, development, and manufacturing services, with the ultimate goal of creating solutions that improve patient outcomes. Driven by innovation, powered by partnership.
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.
NAGASE & CO., LTD.
NAGASE & CO., LTD. is a global integrated business enterprise specialized in chemicals and biomaterials, founded 1832 in Japan with more than 6,900 employees. The NAGASE Group began as a specialized sales agent securing exclusive contracts to sell industry-leading products globally. Over the years, our Life & Healthcare department leveraged our application knowledge and distribution network gathering expertise for pharmaceutical raw materials our global network to transform our business into a hybrid model offering superior manufacturing, processing and R&D functions as well as pharmaceutical drug manufacturing services. Forward-looking to our 200th anniversary we are creating a platform for sustainable growth.
Our group company HAYASHIBARA was founded as a starch syrup manufacturer in 1883 and has grown into a company with strong research and development expertise. They were the pioneer in enzyme technology to manufacture Trehalose on industrial scale commonly used during lyophilization to stabilize not only antibodies but also wide range of proteins. Hayashibara is the only global supplier of injectable grade Trehalose manufactured from starch. High quality Oligosaccharide manufacturing is a key competence.
Hayashibara Co., Ltd. has been awarded a "Gold" rating in a sustainability assessment by EcoVadis.
Our global network spans
• North America
• Latin and South America
• Western Europe
• Central & Eastern Europe
• Middle East & Africa
• Russia & Eurasia
• Asia & Pacific
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.
Pensatech Pharma
Pensatech Pharma GmbH is an innovative contract research and development company located in Berlin/ Germany with a comprehensive portfolio of classical and innovative dosage form technologies, especially for difficult-to-formulate drug molecules (e.g., drugs with poor and/or pH dependent solubility, unstable drugs, large drug molecules) including:
• Parenteral depots including biodegradable poly(lactide-co-glycolide) microparticles/ implants and nondegradable implants, micro- and nano- suspensions
• Oral modified release DDS: multiparticulates (e.g., pellets and minitablets), matrix and coated systems
• Solubility enhancement: micro- and nano-suspensions, solid solutions and dispersions, hot melt extrusion, spray dried dispersions
• Local DDS, in particular ocular and topical
• Patient centric DDS (paediatric and geriatric): multiparticulates, taste masking, fast disintegrating oral DDS
• Highly potent APIs and cytotoxics
Our services include:
• Pre-formulation: material characterization and compatibility of API and excipients
• Formulation and process development: feasibility studies; development of enabling formulations for rapid evaluation in the clinic; full development of a wide range of pharmaceutical dosage forms
• Analytical methods development, optimization, transfer and validation
• Stability studies
• Quality control testing (physicochemical and pharmaceutical analysis) as well as batch certification of finished products and investigational medicinal products in our GMP-certified laboratories
Please contact us at info@pensatechpharma.com to discuss how we could help you during the development of your product.
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 Ribose 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 reducing risk and long-term investment. Products investigate dissolution, solubility, permeation, ionization and absorption properties of compounds and drug products. Pharmaceutical and biopharmaceutical users benefit from richer, more relevant insights not easily accessible prior to animal studies. With a 20+ year heritage, Pion serves a multibillion-dollar global market and is headquartered in Massachusetts with an office in the UK.
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
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, including the study of food effects.
PTS
PTS designs and manufactures new drug delivery systems based on precision polymers like polyaminoacids, PAMAM, PEI, PBAE, HMPA among others. Our state-of-the-art GMP facility consistently delivers high-quality polymers with a very narrow polydispersity. Our company also provides the entire analytical development, CMC package, and stability studies according to the ICH guidelines. PTS delivers customer support at every stage of the product development, from concept to clinical trials. A specialized team works around the clock with our customers to comply with the regulatory agencies, saving our clients both time and money. To learn more visit our website.
Quotient Sciences
Quotient Sciences is dedicated to accelerating the development of new drugs for patients around the world. We provide formulation development, clinical pharmacology trials, and clinical and commercial manufacturing services to the pharmaceutical and biotech industry. These services are provided either individually or as an integrated service offering via our Translational Pharmaceutics® platform.
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 an end-to-end CDMO partner of choice, providing highly tailored solutions to clients while meeting the evolving needs of the global healthcare industry. With proven regulatory approvals, we provide seamless offerings from cell-line development to final fill/finish as well as biosafety testing at every stage for biopharmaceutical products. Our plants are cGMP compliant holding 364KL with a wide range of bioreactor scales. To meet growing market demand, we are currently expanding capabilities with the addition of an mRNA vaccine DS manufacturing suite and construction of a new plant 4 that will hold 620KL total capacity upon completion.
Schrödinger
Schrödinger is a leading provider of advanced molecular simulations and enterprise software solutions that accelerate and increase the efficiency of drug discovery and materials design. Schrödinger has a growing pipeline of early-stage assets and has co-founded leading biotech companies, including Nimbus Therapeutics and Morphic Therapeutic. In addition, the company has deep partnerships and collaborations in such fields as biotechnology, pharmaceuticals, chemicals, and electronics. Through significant long-term investments in basic research, Schrödinger has made scientific breakthroughs across many areas of drug discovery and materials science. Founded in 1990, Schrödinger has nearly 400 employees and operations in the United States, Europe, Japan, and India, as well as business partners in China and Korea.
SEQENS
SEQENS is a world leader in pharmaceutical solutions and specialty ingredients. With 24 production sites and 10 worldwide R&D centers in Europe, North America, and Asia, SEQENS develops tailor-made solutions and ingredients for the most demanding industries such as healthcare, electronics, cosmetics, food, and home care. Driven by a culture of excellence and a strong entrepreneurial spirit, our 3,200 employees are committed to provide our customers the highest level of service and quality while acting ethically in accordance with our Corporate Social Responsibility program.
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
Surface Measurement Systems
Surface Measurement Systems is the world‘s leading developer of innovative experimental techniques and instrumentations for physico-chemical characterisation of complex solids. Inventing the Dynamic Vapor Sorption (DVS) technique and the world‘s most advanced commercial Invest Gas Chromatography (iGC) instrument, we provide unparalleled scientific expertise and technical support for customers around the world.
Used by the world’s top 20 leading pharmaceutical companies and more, Surface Measurement Systems and its instruments are a vital part of ongoing R&D and formulation studies being conducted across the globe.
Providing unparalleled detail and accuracy, our instruments can be employed for analysis of water sorption isotherms, drying and rehydration, amorphous content, diffusion and permeability, stability testing, formulation performance, vapour pressure, hydrates and morphology, polymorphism, vapor pressure, and more.
Visit our booth to discuss how our instruments can provide unrivalled insight into your materials characterization research.
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, Syntegon helps its customers in the global pharmaceutical and food industries to improve people's lives. The company, which is headquartered in Waiblingen, Germany, looks back on more than 160 years of experience and achieved annual sales of 1.4 billion EUR in 2021. In the pharma sector, the company’s intelligent solutions enable the safe and high-quality production, processing, filling, inspection, and packaging of liquid and solid pharmaceuticals. In the food industry, Syntegon’s flexible and reliable technologies produce and pack 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 smooth production processes for all customers. More than 30 sites in almost 20 countries keep a firm eye on Syntegon’s 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.
TTP
TTP is an independent technology company where scientists, engineers and designers collaborate to invent and develop new products and technologies.
Working across healthcare including drug delivery devices, surgical tools, smart implants, diagnostics and digital health, we create breakthrough solutions that bring strong commercial value to clients and the benefits of technology to all.
Our drug delivery team brings together expertise in biology, physics, human-centred design and engineering to develop novel solutions, with experience across a broad range of respiratory, parenteral, and transdermal devices.
Over 80% of TTP’s business is from returning customers – we have cultivated deep, trusting partnerships with pharma and medical device companies through helping them define, develop and deliver successful solutions to the market.
WuXi STA, a subsidiary of WuXi AppTec
WuXi STA, a subsidiary of WuXi AppTec, is a leading CDMO providing integrated CMC service including both API and drug product for small molecule, oligonucleotide, peptide and complex conjugate from preclinical to commercial.
WuXi STA has 8 R&D and manufacturing sites across Asia, North America and Europe including the most recent Couvet site in Switzerland. Our comprehensive drug product platform has a strong R&D team of 1200+ scientists with capabilities in broad oral and parenteral dosage forms. Our bioavailability enhancement technology platform includes spray-dried dispersion, hot melt extrusion, nano suspension and softgel & liquid filled hard capsules.
Zerion
Zerion Pharma A/S is a pharmaceutical company aspiring to transform the pharmaceutical landscape for 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 A/S has pioneered the Dispersome® technology that greatly enhances the solubility of poorly soluble, oral drugs and improves bioavailability and the 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 compatible with standard solid oral dosage form manufacturing.
Zerion Pharma A/S develops proprietary drug formulations and offers the Dispersome®technology to established pharma companies as a means to solve their most challenging drug solubility problems. Through the use of our proprietary Dispersome® formulation platform, we aim to develop new treatment options for patients across all small molecule therapy areas, striving to improve the lives of patients around the world. The Dispersome® technology is patent protected and offers in connection with any pharmaceutical drug many additional years of IP protection.