Biologic API CMO Sourcing Center
Active Pharmaceutical Ingredients (API) for biologics can at times be somewhat more complicated than small-molecule API, involving both sophisticated culture and fermentation of microorganisms as well as chemical compounds and processes.
High degrees of purity and process controls must be maintained in facilities capable of handling large molecules. As biologic products continue to reach commercial acceptance, the needs for capacity and specific capabilities will increase, as will the art and science of developing API.
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Biologic API CMOs
AbbVie Contract Manufacturing
When you engage AbbVie Contract Manufacturing, you’re getting more than a CMO. You fully access the capabilities of a highly experienced biopharmaceutical company. You know that your project will benefit from our broad range of capabilities and portfolio of state-of-the-art facilities in North America and Europe.
Ajinomoto Bio-Pharma Services
Working with Ajinomoto Bio-Pharma Services, you get a trusted CDMO partner that has the power to make your every challenge our own, sharing your unwavering tenacity and dedication from pre-clinical program to commercial successes. We leverage our broad range of capabilities and services at our sites in Belgium, India, Japan, and the US to support your program goals.
Catalent is a global leader in providing integrated services, superior drug delivery technologies and manufacturing solutions to help life science innovators develop and launch successful pharmaceuticals, biologics and consumer health products.
Celanese Corporation is a global chemical leader in the production of differentiated chemistry solutions and specialty materials used in most major industries and consumer applications. Our businesses use the full breadth of Celanese's global chemistry, technology and commercial expertise to create value for our customers, employees, shareholders and the corporation.
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.
Evonik serves as a global development partner and solutions provider to biotechnology companies to help them transform complexity into value. We bring together a broad, versatile range of core competencies, a trusted global network of sites, and strong technical expertise to support you in the development, scale-up, and manufacturing of biopharmaceutical products.
Grifols Recombinant Protein CDMO Services
Grifols provides CDMO services for bulk recombinant proteins produced by microbial and mammalian expression systems for use in diagnostics, therapeutics and vaccines.
Based in the San Francisco Bay Area, we have three decades of process development and GMP manufacturing experience, and we support long-term relationships through expertise, quality, and reliability.
IDT Biologika is a contract development and manufacturing organization offering services for partners committed to the development and marketing of therapeutic and prophylactic vaccines and other biological products. Focused on viral live vaccines and other biopharmaceuticals such as recombinant proteins and monoclonal antibodies, IDT Biologika utilizes state-of-the-art facilities and offers many years of experience in the development of production processes and commercial manufacturing.
JOINN Biologics can take your project from "Digital DNA to final drug product in a vial" all under one roof. We have our own proprietary JOINN CHO-K1 cell line and we are currently validating a Bosch & Strobel vial filling line. Using our new ambr 250, we can optimize your cell culture conditions prior to scale-up for cGMP production of clinical stage bio-therapeutics.
Lonza Pharma & Biotech
Lonza is one of the world’s most renowned companies for contract development and manufacturing, Lonza Pharma & Biotech is recognized for our reliable, high-quality services, our global capacity, our innovative technology platforms, and our extensive experience.
Northway Biotech, an end-to-end CDMO supports biopharmaceutical customers worldwide. Its highly experienced team executes projects from cell line construction and process development to cGMP manufacturing. The company's wide-ranging expertise and vertically integrated service offering translate to the ability to rapidly execute multiple projects from its state-of-the-art GMP facilities while ensuring full process and product compliance at all stages of research, development, and commercial manufacturing.
Ology Bioservices® is now part of Resilience (National Resilience, Inc.). Resilience is a first-of-its-kind manufacturing and technology company offering a network of high-tech, end-to-end manufacturing solutions including production of cell and gene therapies, viral vectors, oncolytic viruses and vaccines. Resilience offers the highest quality and regulatory capabilities with support from IND through Licensure, along with flexible and adaptive facilities to serve partners of all sizes.
Patheon, by Thermo Fisher Scientific
Thermo Fisher Scientific’s Patheon provides industry-leading pharma services solutions for drug development, clinical trial logistics and commercial manufacturing to customers of all sizes.
Rentschler Biopharma, a global leading CDMO, is your outsourcing partner of choice for bioprocess development and cGMP manufacturing. With almost 50 years of proven scientific expertise, we guarantee best-fit solutions for clinical and commercial supply. Our commitment is reflected in our exceptional client-oriented project management and regulatory support. We are headquartered in Laupheim, Germany, with a second site in Milford, MA, USA.
Samsung Biologics is a full-service provider offering development and cGMP manufacturing services. We deliver a broad range of services from development and manufacturing to fill and finish, covering both clinical molecules and commercial products.
Our biomanufacturing facility offers end-to-to end, multiple platform technologies and cGMP manufacturing capabilities for clinical and commercial supply. We provide services for Mammalian, Microbial, Baculovirus and Yeast-derived recombinant products. These include antibodies, bispecific antibodies, antibody fragments as well messenger RNA (mRNA), plasmid DNA (pDNA), Virus-like particles (VLPs), and microbiome. We employ protocol-driven, technology transfer processes to seamlessly integrate projects from customers into our facilities.