Commercial Partners
Commercial Partners 2021
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.
Armor Pharma
ARMOR PHARMA manufactures and markets 3 ranges of pharmaceutical grade lactose for all your applications:
- ARMOR PHARMA™ lactose monohydrate: sieved & milled lactose for sachets, tablets and capsules formulation
- EXCIPRESS™: lactose for Direct Compression
- EXCIPURE™: lactose for Dry powder Inhalation
ARMOR PHARMA's ambition is to design solutions that best support customer's development. Our positioning reflects this philosophy, centred on a question that makes sense: "How would you like your lactose?"
For more information, or to tell us how you would like your lactose:
Bachem
Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With 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
BDD is a specialist pharmaceutical development company providing expertise across all areas of drug delivery. Our service, customised to our clients individual needs, is inclusive of project design, optimal formulation development and lean clinical evaluation.
Our patented, time release technology - OralogiK™ provides unrivalled control of drug release in vivo – delivery at the right place, at the right time.
OralogiK™ enables the delivery of single, multi-dose or drug combinations at pre-determined times post dose. Benefits include:
- Chronotherapeutic oral drug delivery
- Target and effectively exploit Regional Absorption opportunities
- Lean clinical assessment of optimised formulations using BDD’s on site Clinical Unit
Catalent
Catalent is the Number One global leader in drug formulation development. From our robust network of expertise and innovative technologies, Catalent offers the most comprehensive early-phase drug development solutions.
Specializing in analytical and bioavailability enhancement, from preformulation to fully integrated solutions, Catalent helps get your drug to market faster.
Catalent’s integrated solutions, OptiForm® Solution Suite and OptiForm® Total Supply, aide in accelerating your molecule from candidate to clinic.
Our capabilities in spray drying, hot melt extrusion, modified-release, and roller compaction provide our customers with our broad-based expertise in working with challenging compounds to find the optimal dosage form to suit each project.
Clexio
Clexio is a multi-asset clinical stage pharmaceutical company developing novel therapies for patients suffering from neurological and psychiatric conditions.
Our pipeline includes drugs in preclinical stage, Phase 1 stage and Phase 2 stage for indications with major unmet needs: Major Depressive Disorder, Painful Diabetic Neuropathy, Cluster Headache, Parkinson’s Disease and Chronic Pruritus of neurological origin.
Clexio also developed a proprietary drug delivery platform called OLAR® (Oral Long Acting Release platform), a technology designed to provide continuous drug delivery to the GI tract and achieve more efficient drug absorption and lower drug plasma fluctuations.
One of our driving principles is to invent new therapeutic modalities and bring them quickly from idea to Proof of Concept and then to full clinical development.
Individually and as a team, we are excited every day to use our expertise to innovate, integrate, apply, and develop new and effective solutions for patients.
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 the global leader in excipient solutions. We develop, produce and market excipients for oral solid dose and dry powder inhalation. Our portfolio consists of filler/binders (Lactose, Microcrystalline Cellulose, Starches), superdisintegrants (Croscarmellose Sodium and Sodium Starch Glycolate) and carriers for inhalation (Lactose). Please visit dfepharma.com
Elkem Silicones
Elkem Silicones is a fully integrated global silicone manufacturer, with more than 65 years of formulation and manufacturing expertise, providing customized solutions to a wide range of industries including Healthcare.
Elkem Silicones has been active in the silicone market from its very emergence and has a deep-seated knowledge in materials science and engineering, as well as experience in the specific processing needs of pharmaceutical and medical industries. The company constantly monitors changes and innovation in Healthcare and Drug Delivery Systems and communicates these openly with its partners.
Under its Silbione™ brand, Elkem Silicones designs medical grades which have been used for years in Healthcare as well as silicones that can be used as pharmaceutical excipients in Drug Delivery Devices. Indeed, with more than 60 years of use in implantable devices, silicones represent the highest standard for biomaterials.
Elkem Silicones also rely on passionate members you can talk to about innovation in your area of expertise, to understand the technical and financial stakes involved. Elkem Silicones is particularly aware of the need to address both material and processing issues in medical-grade and pharmaceutical products to provide performance and protection for practitioners and patients and to comply to local regulatory standards.
Foster Delivery Science
Foster Delivery Science focuses solely on Hot Melt Extrusion and extrusion processes to blend client API’s with polymers for several possible purposes: Solubility and bioavailability enhancement; create local delivery solutions such as drug loaded films, implants and fibers; create delivery or release profiles; and capture the powerful mixing capabilities of twin screw extruders. Operating from our new GMP facility 75 minutes from Boston in CT, we provide formulation development services, scale up, clinical trial material and ready for GMP manufacturing.
Gore & Associates
As a global materials science company, Gore collaborates with pharmaceutical companies to design materials-based solutions that fit their requirements for product purity, process effectiveness and device performance. Our newest innovation, the GORE ImproJect Plunger for pre-filled syringes protects sensitive biologics from silicone-induced particle formation and protein aggregation since Gore has eliminated the need for silicone in both the plunger and barrel.
Halo Labs
Halo Labs knows particles. The Aura, our flagship product, can count and characterize subvisible particles - and tell you whether they are proteinaceous or non-proteinaceous. A simple, plate-based approach enables low-volume, high-throughput, fully automated particle imaging and analysis at any stage from developability assessment through quality control.
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
IGS GeboJagema
IGS GeboJagema is a toolmaker with 120 Fte, located in Eindhoven, the Netherlands. 99% of our turnover is export (of which 40% to US)
Our focus is high precison moulds needed for injection moulded components used in:
- Medical Drug delivery devices, - Closures (Luer Lock) - Packaging and - Consumables/Disposables.
- Optics,
- BioTech consumables (Cartridges, Cassettes, Cuvettes-Tubes, Strip Lid and Wellplates,
Many pharma and biotech companies have approved IGS as their preferred toolmaking partner and involve IGS in their projects.
Because we want to meet “a first time right delivery”, we have 8 injection moulding machines on site and extra space for 12 extra customers injection moulding machines for a turkey set up/delivery.
Clients characterize IGS as:
- open and transparent in all our communication,
- a partner with added value towards Innovative Product Design Input to reduce TCO of the tooling costs,
- delivery of a full validated mould, including moulding process parameters for a first time right delivery
- partner with engineering, manufacturing and validation power, to run several moulds (6 to 10) at the same time for one project.
We invite you to challenge our Team and involve in your new product and send us your NDA/mold RFQ
leon-nanodrugs
Leon-nanodrugs GmbH (Munich) is a nanotechnology-based drug development company focused on development of novel oral and parenteral formulations and innovative drug combinations.
The proprietary and patent-protected MicroJetReactor Technology by leon-nanodrugs is a bottom-up approach for nano- and microparticle synthesis. Basis of the process is a continuous solvent / non-solvent precipitation that is performed under precisely controlled process conditions.
Build on its “network of expertise”, leon-nanodrugs can provide a 360 degree competence range – from concept to product approval.
Leon-nanodrugs proprietary MJR® Technology offers access to the next generation nano formulated drugs with added patient benefits and economical values for its partners and shareholders.
Lonza Pharma & Biotech
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)
Maiwald
MedinCell
MedinCell is a clinical stage pharmaceutical company that develops a portfolio of long-acting injectable products in various therapeutic areas by combining its proprietary BEPO® technology with active ingredients already known and marketed. Through the controlled and extended release of the active pharmaceutical ingredient, MedinCell makes medical treatments more efficient, particularly thanks to improved compliance, i.e. compliance with medical prescriptions, and to a significant reduction in the quantity of medication required as part of a one-off or chronic treatment. The BEPO® technology makes it possible to control and guarantee the regular delivery of a drug at the optimal therapeutic dose for several days, weeks or months starting from the subcutaneous or local injection of a simple deposit of a few millimeters, fully bioresorbable. Based in Montpellier, MedinCell currently employs more than 130 people representing over 25 different nationalities.
Munit SA
MUNIT is a consultancy company, operating in the field of MICRONIZATION of Active Pharmaceutical Ingredients (APIs), High Potent APIs, Cytotoxic and Cytostatic compounds, Inhalation products, Steroids, R&D compounds and Generics.
In MUNIT we have combined the technical and commercial expertise of its affiliates Jetpharma SA (Switzerland) and Microchem Srl (Italy) making the best out of 40 years of leadership in the micronization sector.
MUNIT is your access point to JETPHARMAs and MICROCHEMs services:
- Jet- , Pin- and Hammer milling
- Cryogenic Micronization
- Co- micronization
- Sieving, Blending, De-Lumping
- Technical trials, DoE Studies, Process development and validation
- QbD
- PSD analysis etc.
With MUNITs lean organisation, its welcoming and customer orientated attitude, we are able to guarantee best service, high efficiency and punctuality to our customers worldwide.
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.
Nanomol Technologies
Nanomol Technologies is a science and innovation driven company offering novel nanoformulation solutions by our patent protected, green and robust DELOS platform, in addition to advanced cGMP particle characterization services to pharma, biotech and chemical companies.
DELOS nanocarriers stabilize, protect and improve the performance of APIs -from small chemical molecules to biologics, including peptides, proteins and nucleic acids, of interest of our partners, enabling new administration routes and enhanced drug products.
We work with our partners to unlock pharmaceutical R&D, generating high quality nanomedicines that successfully reach clinical phases:
- Reformulating drug candidates with poor solubility, bioavailability or stability.
- Obtaining tailored multifunctional drug delivery systems that overcome cell barriers and reach specific tissues.
Oval Medical Technologies
Our patient-centric autoinjectors are designed, developed, and industrialised in Cambridge, UK . We aim to empower patients to feel confident, comfortable, and relaxed about injecting their medicine. Our deep expertise means we can meet the most challenging requirements arising from diverse patient groups and novel drug formulations. Oval’s core technology is our primary drug container which enables true design freedom.
We offer a complete turn-key solution leveraged through the SMC Group of companies, dedicated to enabling a better and faster customer journey from product development to patient.
Pensatech Pharma
Pensatech Pharma GmbH is an innovative contract drug research and development company located in Berlin/ Germany with a comprehensive portfolio of classical and innovative dosage form technologies. We offer a wide range of drug delivery technologies especially for difficult-to-formulate drug molecules (e.g., drugs with poor and/or pH dependent solubility, unstable drugs, large drug molecules) including:
- Oral modified release drug delivery systems: granules, pellets, minitablets, osmotic tablets, matrix and coated systems
- Parenteral: biodegradable PLGA microparticles and implants, aqueous and oily solutions, micro- and nano- suspensions, lyophilization
- Local DDS, in particular ocular and topical
- Solubility enhancement: micro- and nano-suspensions, solid solutions and dispersions, hot melt extrusion (HME), spray dried dispersions (SDD)
- Patient centric DDS (paediatric and geriatric): multiparticulates, minitablets, taste masking, fast disintegrating oral drug delivery systems
- Stability improvement
- Highly potent APIs and cytotoxics
- High dose DDS
- Classical dosage forms: granules, pellets, tablets, capsules, coating systems (aqueous- and solvent-based), aqueous and oily solutions / suspensions and gels
- 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
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.
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
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.
Recipharm
Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) in the pharmaceutical industry employing almost 9,000 employees. Recipharm offers manufacturing services of pharmaceuticals in various dosage forms, production of clinical trial material and APIs, and pharmaceutical product development. Recipharm manufactures several hundred different products to customers ranging from big pharma to smaller research and development companies. Recipharm’s turnover is approximately SEK 7.5 billion. The company operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden, the UK and the US and is headquartered in Stockholm, Sweden. The Recipharm B-share (RECI B) is listed on Nasdaq Stockholm.
For more information on Recipharm and our services, please visit www.recipharm.com or follow us on LinkedIn.
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.
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.
Sensile Medical
Sensile Medical develops on- and off-body worn liquid drug delivery devices. Our technology offers a highly customizable, safe and cost-efficient device platform for small and large volumes. The micro-infusion pumps enable highly precise dosing at variable delivery patterns and offer various opportunities to inject a drug without the need of changing the primary packaging. Our proficiencies range from design to industrialization including manufacturing, digital health solutions. The first pump for the treatment of Parkinson`s disease was launched by EVER Pharma in 2019. Sensile Medical is a Swiss company established in 2004 and a subsidiary of Gerresheimer AG since 2018.
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
Tesa Labtec
tesa Labtec is working more than three decades in the field of planar dosage forms. Our technologies are transdermal and topical patches, orodispersible thin films and topical & mucoadhesive oral films.
We are your full end B2B-CDMO supporting to transfer your product ideas to market. Planar dosage forms show many advantages over traditional administration forms.
Other
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’ inhaled and nasal 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 and we have recently announced a significant expansion to double our laboratory footprint and further increase our capacity and flexibility. Through our expertise in analytical and formulation support for the pharmaceutical, biotechnology and drug delivery industries, we help our clients 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.
- 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
Tel +44 1763 261 648, email: inhalation@intertek.com