FOUNDING & SUSTAINING MEMBERS
Afton Scientific operates cGMP facilities designed and approved for the manufacture of aseptic and terminally sterilized parenteral drugs for clinical trials and commercial filings. Specializing in small batch parenterals, Afton has capabilities to formulate, sterilize, fill, label, serialize, and package batches from 100 – 40,000 units with fill volumes of <1mL – 100mL. Afton has a history of successful NDA and ANDA drug registrations and audits by the FDA, MHRA, and PMDA. Our experienced team works with clients from start to finish including assistance with process development up through regulatory filing and beyond. Our focus is always the success of your product. Afton is also the global leader in pre-sterilized (Ready-To-Fill®) vials, stoppers, and seals.
BioPharma Solutions, a business unit of Baxter, partners with pharmaceutical companies to support their commercialization objectives by providing scientific expertise, sterile contract manufacturing solutions, parenteral delivery systems, and customized support services needed to meet the unique challenges that parenteral products face. Experience makes the difference: with over 80 years of parenteral expertise, we can help to navigate the pathway of success for your molecule. BioPharma Solutions provides our clients with confidence of delivery, service, and integrity – we know the work we do is ultimately vital to the patients you serve. BioPharma Solutions offers resources to help solve the high-stakes challenges you face in today’s complex parenteral marketplace.
Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. With over 35 years’ experience and a growing team of more than 2,000 experts servicing our global clients from our sites in North America and Europe, we are tried and trusted in branded and generic markets for API and dosage form development and manufacturing.
- Drug Substance: From laboratory to commercial supply, we’re in a great position to offer you the very best in drug substance services.
- Drug Product: Our capabilities and expertise include pre-formulation and clinical supply, tech transfer, process and pharmaceutical product development, formulation development, scale-up and validation, analytical method development, commercial manufacturing and packaging.
- Analytical Services: Trust our analytical development and testing experts to rapidly advance your molecule for the greatest chance of success. Led by our broad experience and collaborative approach, we are committed to finding the shortest, most efficient path to success for our customers.
Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs more than 10,000 people, including over 1,400 scientists, at more than 30 facilities across five continents and in fiscal 2017 generated $2 billion in annual revenue. Catalent is headquartered in Somerset, NJ.
Jubilant HollisterStier Contract Manufacturing & Services is an integrated contract manufacturer of sterile injectables, ophthalmics, otics and sterile and non-sterile topicals and liquids. Our facilities in North America provide specialized manufacturing services for the pharmaceutical and biopharmaceutical industries. We provide a full range of support and services to streamline the manufacturing process such as on-site assistance from process qualifications through product release.
Kindeva Drug Delivery is a leading global contract development and manufacturing organization (CDMO) in the pharmaceutical industry. Kindeva provides unique technologies and quality services to its customers, ranging from formulation and product development to commercial manufacturing. Kindeva focuses on complex drug programs, and its current offering spans inhalation drug delivery, transdermal drug delivery, microstructured transdermal systems (microsystems), and connected drug delivery. Kindeva employs approximately 900 people at six facilities worldwide. Formerly 3M Drug Delivery Systems, Kindeva is built on decades of industry leadership and innovation. Kindeva launched as an independent company in 2020. For more information, visit www.kindevadd.com.
Metrics Contract Services (Greenville, NC) is a full-service global CDMO specializing in oral dosage forms. A subsidiary of Mayne Pharma USA, Metrics offers clients comprehensive analytical and formulation development from first-time-in-man (FTIM) through Phase I, II, III CTM manufacturing and commercial launch. Unique capabilities include potent and cytotoxic compound controls (OEL 3A and 3B), controlled substances, bioavailability enhancement and modified release.
Patheon, part of Thermo Fisher Scientific, is a leading provider of CDMO services to the global pharmaceutical industry for a full array of solid and sterile dosage forms. Patheon encompasses the combined CMO capabilities and pharmaceutical product development services (PDS), as well as the Biosolutions and Biologics (BIO) business.
Pfizer CentreOne® is a global CDMO embedded within Pfizer and a leading supplier of specialty APIs. Our global manufacturing network includes more than 35 sites across six continents. Backed by Pfizer resources, we deliver technical expertise, global regulatory support and long-term supply. For more than 40 years, we’ve been guiding complex compounds securely and efficiently from development through commercial manufacture.
Working together with our customers, we combine our knowledge with open dialogue to solve challenges. Intelligent collaboration with Pfizer CentreOne. For more information, visit www.pfizercentreone.com.
Piramal Pharma Solutions is a Contract Development and Manufacturing Organization (CDMO), offering the end-to-end services required to bring a drug into the marketplace quickly and safely. We offer Pharmaceutical Development and Manufacturing solutions through collaborative partnership models, and we work with our customers throughout the drug life cycle to ensure quality and unparalleled customer service. At Piramal Pharma Solutions, we have carefully created a vast network of Development and Manufacturing facilities located in North America, Europe and Asia that offer all services necessary during a drug’s life cycle, from Drug Discovery & Development to Commercial Manufacturing of off-patent Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs). Our capability as an integrated service provider and our experience with various technologies enables us to serve both Innovator and Generic companies worldwide.
Ajinomoto Bio•Pharma Services is a fully integrated CDMO providing comprehensive process development services, cGMP manufacturing and drug product fill finish services of small molecule and biologic APIs and intermediates. Ajinomoto Bio-Pharma Services offers a broad range of innovative platforms and capabilities to rapidly scale from clinical and pilot programs to commercial quantities, including: Corynex technologies, oglionucleotide synthesis, antibody drug conjugations (ADC), high potency APIs (HPAPI), continuous flow manufacturing and more.
AAIPharma Services Corp. and Cambridge Major Laboratories, Inc. have joined to form Alcami, a world-class supplier of comprehensive pharmaceutical development and manufacturing services. With seven sites across the globe, our combined capabilities include API development and manufacturing, solid state chemistry, formulation development, analytical development and testing services, clinical and commercial finished dosage form manufacturing (oral solid dose and parenteral), packaging, and stability services.
ApiJect Systems Corp. is a medical technology company that is revolutionizing how the world manufactures and delivers injectable medicines and vaccines. The ApiJect technology platform brings together simple, interconnectable components to create scalable drug delivery devices for U.S. and global markets. At the center of these devices is the aseptic and cost-effective Blow-Fill-Seal (BFS) fill-finish process. And, by using a modular manufacturing approach, these devices can be produced in clinical- or commercial-scale by ApiJect or the drug manufacturer. Our first device, the ApiJect Prefilled Injector, allows a healthcare professional to twist a pen needle-style hub onto a BFS container – creating a simple, scalable prefilled syringe. The Prefilled Injector has been submitted for FDA review and has not been approved by regulatory authorities.
Avid Bioservices (NASDAQ: CDMO) is a USA-based CDMO focused on development and manufacturing of biopharmaceutical drug substances derived from mammalian cell culture. The company provides a comprehensive range of process development, CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With nearly 3 decades of experience producing monoclonal antibodies and recombinant proteins, Avid’s services include CGMP clinical and commercial drug substance manufacturing, bulk packaging, release and stability testing and regulatory submissions support. For early-stage programs Avid provides a variety of process development activities, including upstream and downstream development and optimization, analytical methods development, testing and characterization.
Bora Pharmaceuticals is a premier international CGMP CDMO specializing in complex oral solid dosage (tablet & capsules), liquids (solutions, suspensions, & nasal sprays) and semi-solids (creams & gels) pharmaceutical products for late-phase Clinical through Commercial manufacturing and packaging. Bora owns and operates three state-of-the-art CGMP manufacturing facilities in Taiwan and Canada built to the highest international standards for manufacturing, packaging, R&D, and analytical testing. Bora’s TAA-compliant manufacturing sites deliver products to over 100 markets worldwide including the US, Canada, EU, Southeast Asia, Middle East, and South and Central Americas.
CMIC CMO USA (“CCU”) is a part of the CMIC Holdings group, a pioneer and leading CRO company in Japan providing comprehensive support services to pharmaceutical companies throughout their whole value chain, including development, manufacturing, sales and marketing: a pharmaceutical value creator. For over 10 years, CCU has provided fully integrated contract development, manufacturing, and analytical testing solutions of oral solid dosage forms, from early drug development through clinical and commercial manufacturing. With strong expertise in all fluid bed technologies, CCU can provide solutions to even the most challenging solid dose formulations. Together with the seamless collaboration with our CDMO division in Japan and Korea, CCU is uniquely positioned to serve as the pharmaceutical industry’s preferred strategic partner.
Coating Place, founded in 1976, has over 40 years of experience in the CDMO industry. The company has advanced the design of their Wurster coating units by developing proprietary fluidization plates and nozzles. This technology, along with the feasibility and product development services, enables Coating Place to provide customers with the highest quality services available in the Wurster fluid bed coating industry. In addition to Wurster coating abilities, Coating Place is also capable of many other support services for research and commercial manufacturing. This includes services such as granulation, extrusion/spheronization, ball milling, tableting and capsules filing. Our capabilities are flexible enough to coat small batches of roughly 10g up to 800kg. Coating Place combines experience and expertise in engineering, development and manufacturing to offer efficiency in the movement of a project from the small-scale development phase to commercial manufacturing.
Cytovance® Biologics is a biopharmaceutical contract manufacturing company specializing in the production of therapeutic proteins and antibodies from both mammalian cell culture and microbial fermentation. In addition to its cGMP manufacturing services, the company offers process development, cGMP cell banking and support services from its Oklahoma City state-of-the-art facilities.
DPT, a Mylan company, is a leading contract development and manufacturing organization specializing in semi-solid and liquid dosage forms. Working in close consultation with clients, our experts streamline development from pre-formulation through commercialization. With an 80-year legacy of excellence, unmatched technical expertise and fully integrated drug development and manufacturing services, DPT delivers proof in every product.
Frontida BioPharm, Inc. is a US-based, minority-owned CDMO, providing drug delivery technologies, product development, and manufacturing services. Frontida supports pharmaceutical companies in the development, scale-up and commercial manufacturing of immediate and controlled-release oral solid dose, powder and liquid products; ensuring robust product performance and on-time supply of clinical trial materials and commercial products. Our Philadelphia, PA and Aurora, IL manufacturing facilities offer a comprehensive suite of solutions for the development and commercialization of prescription, OTC, Highly Potent Active compounds, Phase I through Phase III clinical trial materials, Fixed-dose Combination products and DEA schedule II – V products.
Grand River Aseptic Manufacturing (GRAM) is a full-service parenteral contract manufacturer, approved by the FDA for aseptic manufacturing, with and without terminal sterilization. We are located in two facilities in downtown Grand Rapids, Michigan. Thanks to our highly skilled, experienced people and a state-of-the-art cleanroom, we are able to take projects from pre-clinical trials through successful commercialism. At GRAM, we treat every client project, regardless of volume or complexity, as if it were our own.
Groupe PARIMA is an integrated Contract Development and Manufacturing Organization (CDMO) specialized in the development and manufacturing of non-sterile liquid, suspension, semi-solid and spray drug products. We have over 20 years expertise in supporting the full life-cycle of drug products, from initial formulation development to manufacturing of clinical lots and then full commercial scale manufacturing. With presence in 27 countries, we operate on a global scale. In our US-FDA and Health Canada inspected facility, we currently develop and manufacture drug products (prescription and OTC) for the US and Canadian markets, in addition to the European, Asian, Latin and South American markets. We can serve as your gateway to overseas markets.
As the global leader in manufacturing and supplying sodium hyaluronate (NaHy), Lifecore Biomedical has helped more than 90 million patients benefit from our certified pharmaceutical grade NaHy. We are using our expertise in handling highly viscous solutions to expand our contract development and commercial manufacturing services to solve complex drug development challenges. Lifecore Biomedical, Inc. is a wholly owned subsidiary of Landec Corporation (Nasdaq: LNDC). We are fully committed to the quality and service that ensures our products meet the highest standards set by the United States Food and Drug Administration, the European Community and other international agencies. We operate two facilities that are ISO 13485 and GMP certified, international symbols of quality system assurance and compliance.
LSNE Contract Manufacturing is a privately held company with three manufacturing facilities located in New England. LSNE has been providing cGMP services to the pharmaceutical, biotechnology and medical device industries since 1997; specializing in a wide range of services including process development, fill/finish and lyophilization. LSNE offers both the flexible approach commonly required with preclinical projects, as well as the cGMP framework necessary for late stage clinical and commercial manufacturing. Through the thoughtful integration of three processing facilities, qualified staffing and an extensive manufacturing history, LSNE is strategically positioned to provide uninterrupted material for clinical through commercial.
Founded in 1991, Particle Sciences has established itself as a leading contract development and manufacturing organization (CDMO). Staffed by experienced industry experts we offer drug product formulation and a comprehensive suite of supporting services including analytic, bioanalytic, physical characterization and manufacturing. A variety of technologies and the ability to deal with poorly soluble and highly potent compounds under GxPs in both sterile and non-sterile environments distinguishes Particle Sciences from others. Our goal is to design and produce the most effective drug products for our clients. From the beginning, we have been leading the way with commercial innovations, scaling our first nano-particle back in 1994 to over 500,000kg per year. Today our clients include over half of the leading pharmaceutical and biotech companies, governments, foundations, universities, hospitals and privately-backed start-ups.
PCI is an integrated full-service provider and a trusted partner of many leading pharmaceutical companies globally; we offer unparalleled expertise and experience in taking compounds from the earliest stages of development through to commercial launch, delivering speed to market and commercial success for our customers. Core services include: Analytical services, formulation development, clinical trial services, commercial manufacturing and packaging, QP services, supply chain management, storage and distribution. Customers may choose to use us as a complete development partner and benefit from our full range of services or choose any of our core services as a stand-alone offering.
Pharma Packaging Solutions (PPS) is a turn-key contract packager, offering commercial packaging, product launches, stability services, cold chain packaging and product retain services to regulated, healthcare industries. We offer primary filling, secondary packaging, kitting services and folding cartons, applying our 20+ years in the contract packaging marketplace. Our facilities are state of the art and readily scalable to accommodate a wide variety of regulated packaging requirements. PPS is a temperature and humidity-controlled site and maintains video surveillance of the packaging suites. PPS offers “cold-chain” refrigeration, serving temperature-sensitive product packaging. Our site is approved by FDA, DEA, MHRA and the Tennessee Board of Pharmacy.
Pharmaceutics International, Inc. (Pii) is a premier Contract Development and Manufacturing Organization (CDMO), offering unparalleled scientific insight and depth of product knowledge, while supplying high quality dosage forms that enhance the lives of patients worldwide. Founded in 1994, Pii has grown from 12 employees to over 300 scientists and support staff and over 360,000 square feet of space in the U.S. Pii’s cGMP facilities are state-of-the-art and contain over 70 manufacturing rooms as well as containment suites for handling high potency compounds and hormones, dedicated manufacturing suites for soft gels and injectables, a formulation development center, and analytical laboratories. Pii provides customized and flexible solutions, across several dosage forms and has experience with a broad range of compounds. For twenty-five years Pii has been supporting its pharmaceutical partners (from virtual to multinational) with extensive technical capabilities, know-how, and the highest level of customer service. With more than 400 development programs completed, Pii’s scientific team has extensive experience working with drug substances representing a range of physicochemical characteristics (and challenges). Our specialized capabilities, multi-product facilities and knowledge-base, allow us to work with potent compounds and hormones, develop complex dosage forms, and support varied manufacturing processes.
POLUS Inc. was first established in March 1, 2016 in Incheon, Republic of Korea with an aim to develop and commercialize biosimilar products, POLUS constructed a large scale cGMP manufacturing plant in Hwaseong, Gyeonggi-do. POLUS Hwaseong manufacturing plant with additional installation of equipment is capable of producing both COVID-19 mRNA and DNA vaccines. To contribute to end COVID-19 pandemic, POLUS is currently discussing contract manufacturing with vaccine developers and strategic partnership with world’s leading contract manufacturing organizations. Current Hwaseong manufacturing plant is equipped with BioEngineering Bioreactor 2 x 10,000-L for Upstream, GE Healthcare’s Chromatrography and UF/DF from Sartorius for Downstream, and BOSCH Filling machines capable of filling 150 million vials per year. To manufacture sufficient multivalent mRNA DS, POLUS is planning to use both Single-Use Equipment from Sartorius and Hybrid (using both fixed conventional equipment and single use equipment) to maximize the production volume.
Recro® is a contract development and manufacturing organization (CDMO) with capabilities from early feasibility to commercial manufacturing. Recro provides end-to-end regulatory support, clinical and commercial manufacturing, and packaging and logistics services to the global pharmaceutical market with expertise in solving complex manufacturing problems for oral solid dosage forms. Additionally, Recro has experience handling DEA-controlled substances and developing and manufacturing modified release oral solid dosage forms. Recro has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, totaling 120,000 square feet, in Gainesville, GA.
Renaissance develops and manufactures high-quality pharmaceuticals to fulfill specific patient needs. Renaissance recognizes that patient care relies on quality pharmaceutical drugs that have gained the confidence of healthcare professionals. We are working passionately as a trusted contract manufacturer while building a specialized portfolio of pharmaceutical products that you can trust to be time-tested, safe, reliable and proven. With decades of experience and our state-of-the-art facility in Lakewood, NJ, we can develop and manufacture a broad range of sterile and/or environmentally controlled products. From early-stage development through final production, Renaissance has the expertise and resources you need for success.
Selkirk Pharma is constructing a 115,000 sq. ft. contract manufacturing facility in Spokane, WA that will specialize in the aseptic fill and finish of vials and syringes. Our mission is to be the most reliable manufacturer of injectable drug product — delivering the highest quality and most cost-effective aseptic manufacturing services available — on time, in full and without errors. Our facility utilizes state of the art isolator filling systems and electronic batch record technology. New capacity will be available in 2022.
Sharp, part of UDG healthcare, is a global leader in clinical supply chain services and contract pharmaceutical packaging. Offering solutions and support to pharma and biotech clients from phase I trials all the way through to commercialization and rapid launch. The organization has state-of-the-art facilities in the United States, United Kingdom, Belgium and the Netherlands and over 32 clinical depots globally, covering every region of the world. Through our partnership with Berkshire Sterile Manufacturing we also offer specialist isolator-based filling of vials, syringes, cartridges and containers, as well as lyophilization and terminal sterilization. Our full complement of integrated services includes: analytical, formulation development, clinical manufacturing & packaging, clinical IRT, blister packaging, bottling, secondary assembly and labelling of injectable presentations, compliance packaging, as well as storage and distribution. Sharp also offers Qualified Person (QP) services for UK and European distribution.
Singota Solutions is a Contract Development and Manufacturing Organization focused on getting products to patients faster by being agile, accountable, and transparent. Our aseptic manufacturing service features a completely gloveless, robotic workcell which provides a highly repeatable and precisely controlled process for filling injectable products into vial, syringe, and cartridge formats. This enhances our ability to manufacture smaller batch sizes and minimize line loss. We also provide customized solutions for formulation development, supply chain & materials management, analytical testing, and labeling & kitting services.
Sovereign Pharmaceuticals, LLC, is a privately owned and operated, full-service, contract developer and manufacturer established in 1990. Sovereign is centrally located in Fort Worth, Texas, and occupies a 54,000 ft2 cGMP production facility and a 14,500 square foot cGMP R&D/QC facility. Sovereign specializes in developing and manufacturing oral tablets, oral capsules, oral and topical solutions, and oral suspensions. Sovereign’s committed team of employees excels in cGMP compliance and is focused on customer service by delivering high quality products at a competitive price in a timely manner.
With nearly 70 years of building expertise in evolving core competencies, Tapemark is unmatched in transdermal, oral film, and topical drug delivery systems. Utilizing the expertise and experience of our staff, we produce the highest quality products in the market. Having worked with hundreds of clients from around the globe, we are proud to partner with pharmaceutical makes of every shape and size.
First established in 1952, Tapemark’s first service offering was printing on self-wound tape. As an early leader in pressure-sensitive adhesives, our expertise evolved to include single-use medical and personal care products. Today, we specialize in the development and manufacturing of multiple drug delivery systems, delivering both Rx and OTC pharmaceuticals through transdermal patches, oral films, and unit dose topical applicators.
Our 150,000 square-foot facility, located in St. Paul, MN, features 13 class 100,000 clean rooms, a full on-site analytical laboratory, a full-service formulation laboratory, 150 full-time employees, and a flexible shift structure to accommodate 24/7 production. Throughout our entire history, Tapemark has been privately held and family-owned, with consistent leadership.
Headquartered in Ravensburg, Germany, Vetter is a family-owned, global leading contract development and manufacturing organization (CDMO) with production facilities in Germany and the United States. Currently employing 5,000 individuals worldwide, the company has long-term experience in supporting biotechnology and pharmaceutical customers both large and small. Vetter services range from early stage development support including clinical manufacturing, to commercial supply and numerous packaging solutions for vials, syringes and cartridges. As a leading solution provider, Vetter appreciates its responsibility to support the needs of its customers by developing devices that contribute to increased patient safety, convenience, and enhanced compliance. Great importance is also given to social responsibility including environmental protection and sustainability. Learn more about Vetter at www.vetter-pharma.com.
With a legacy as a premiere aseptic blow-fill-seal technology company, Woodstock Sterile Solutions is a leading global provider of best-in-class sterile development and manufacturing solutions. We are focused on improving patient care by providing our partners the best solutions to their development and commercial needs. As a full-service CDMO, we have a multi-decade track record in successfully developing early-stage molecules through commercial production, meeting global regulatory requirements. Our expertise and commitment to innovation allow us to reduce development times and efficiently bring products to market. At Woodstock Sterile Solutions, we see a patient, family member or friend in every product we make. Our goal is to be the best development partner in the industry, delivering life-enhancing molecules from concept to patient.