Biologic API 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
AcuraBio
AcuraBio is an Australia-based contract development and manufacturing organization (CDMO) that provides development and biomanufacturing to the pharmaceutical, biotechnology, and veterinary industries.
Australia offers biopharma companies a streamlined regulatory framework and generous tax incentives making it a prime location for biotech research. For more than 20 years, AcuraBio has been a world leader specializing in recombinant proteins and vaccines and complex live therapeutic products.
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.
Capabilities
Asymchem
For over 20 years, Asymchem has been positioned and structured to act as a true partner for pharmaceutical and biotech companies worldwide by offering integrated solutions across all stages of drug development and into commercialization.
As a CDMO with 8 state-of-the-art manufacturing sites, Asymchem's breadth of capabilities spans conventional batch manufacturing, and we are a world leader in green chemistry.
Capabilities
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Catalent
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.
Capabilities
Celanese
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.
Capabilities
CHIRON® Recombinant Proteins
CHIRON® Recombinant Proteins partners with companies interested in developing complex proteins into therapeutics, vaccines or diagnostics. Our state-of-the-art GMP biological manufacturing CMF facility located in the San Francisco Bay Area is well positioned to provide long-term, high-quality, commercial manufacturing of recombinant biologic drug substances to our customers, regardless of their global location.
Emergent CDMO
Emergent CDMO is dedicated to helping biopharma innovators bring life-saving, life-extending therapies to patients throughout the world. We have supported the development and manufacture of over 40 commercial and more than 200 clinical programs for our partners. As a dedicated and experienced global CDMO solutions provider, we can support preclinical to commercial production of therapeutics and vaccines.
Evonik
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.
Capabilities
Kymanox Corporation
Kymanox is a life science professional services organization that offers engineering, scientific, and compliance support to companies exclusively in the biotechnology, pharmaceutical, medical device, and combination product industries. With its diverse team, Kymanox helps clients navigate commercialization challenges that arise throughout a product's lifecycle – from early development to post-market commercialization – with optimized safety, quality, efficacy, and accessibility.
Lonza
Lonza is a preferred global partner to the pharmaceutical, biotech and nutrition markets. We work to enable a healthier world by supporting our customers to deliver new and innovative medicines that help treat a wide range of diseases. We achieve this by combining technological insight with world-class manufacturing, scientific expertise and process excellence. Our unparalleled breadth of offerings enables our customers to commercialize their discoveries and innovations in the healthcare industry.
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
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.
Capabilities
Resilience US, Inc.
Resilience is a manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions with the aim to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to offer regulatory capabilities and flexible and adaptive facilities to serve partners of all sizes.
Samsung Biologics
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.
Syngene International
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.
Capabilities