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
AbbVie
When you engage AbbVie Contract Manufacturing, you're getting more than a CMO. You 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. Most of all, you know that your project will be reliably served by a business with a trusted reputation for innovation, reliability, compliance and delivery.
Capabilities
Abzena
Abzena is the leading end-to-end bioconjugate and complex biologics CDMO + CRO. From discovery through commercial launch, we support customers with fully integrated programs or individual services designed to de-risk and streamline the development of new treatments for patients in need. Abzena develops and implements innovative solutions that enable biotech and biopharma companies to realize the full potential of their molecule.
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
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Aldevron
For 25 years Aldevron has been a catalyst, advancing therapeutic and vaccine development through expert plasmid DNA, RNA, and protein custom manufacturing, supporting our clients from discovery to commercialization. Our custom development and manufacturing services have given scientists around the world essential components to accelerate their research and make a difference.
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
Curia
Curia is a Contract Development and Manufacturing Organization with over 30 years of experience, an integrated network of 27 global sites, and over 3,500 employees partnering with customers to make treatments broadly accessible to patients. Our biologics and small molecule offering spans discovery through commercialization, with integrated regulatory and analytical capabilities.
Capabilities
EirGenix Inc.
EirGenix is Taiwan's largest contract development and manufacturing organization (CDMO) for mammalian and microbial-derived biologics, providing full, one-stop services from pre-clinical development, CLD, Process Development, Analytical Development, Clinical to CGMP commercial manufacturing. EirGenix has extensive experience with various biologics including monoclonal and bi/poly-specific antibodies, recombinant proteins, antibody-drug conjugates (ADCs), and plasmid DNAs including developing and manufacturing a marketed biosimilar.
Capabilities
FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies is a CDMO Partner for Life. We combine technical leadership in cell culture, microbial fermentation and advanced therapies with world class cGMP manufacturing facilities and superior program management to advance tomorrow's medicines.
IDT Biologika
IDT Biologika is a global CDMO for Innovative Vaccines, Cell & Gene Therapeutics and Aseptic Fill-Finish of other biologics. We offer clients a single source CDMO partner at our sites in Germany and the USA, with seamless end-to-end solutions and the ability to nimbly scale projects from development through to commercialization. This includes Process Development, Drug Substance Manufacturing, Sterile Dosage Fill-Finish, Labelling & Packaging, Quality Control & Analytics.
JOINN Biologics
JOINN Biologics is a fully integrated CDMO located in Richmond, CA. JOINN Biologics is a combination of "Big Pharma Infrastructure" with 200L and 1000L traditional stainless steel bioreactors combined with new state-of-the-art single-use bioreactors at the 50L, 200L, and 500L scale. Using our new ambr 250, we can optimize your cell culture conditions prior to scale-up for cGMP production of clinical-stage biotherapeutics.
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.
Mabion
Mabion is a fully integrated CDMO located in central Europe that offers an "end-to-end" solution, covering all stages of drug development: from early clone selection and small-scale manufacturing through process scale-up, large-scale manufacturing, and quality control down to sterile fill-finish, packaging and serialization, bioanalytics, and regulatory support. Broad capabilities and experienced staff make Mabion a perfect long-term partner for any project involving therapeutic proteins.
Nanoform
Nanoform is an innovative nanoparticle medicine enabling company. Nanoform works together with pharma and biotech partners to improve the lives of patients globally by overcoming drug development and delivery challenges through its game-changing nanoforming technologies, novel formulation capabilities and GMP manufacturing facilities. The company's dedicated, multi-disciplinary team has a combined experience of launching 100+ medicines.
Novartis Contract Manufacturing
Novartis Contract Manufacturing is a fully integrated CDMO offering end-to-end manufacturing solutions for mammalian, microbial, advanced therapies (pDNA, mRNA, siRNA, autologous cell therapies, viral vectors), oligonucleotides, drug product, device assembly and packaging to meet our clients clinical and commercial supply needs.
Capabilities
ReciBioPharm
ReciBioPharm is a contract development and manufacturing organization (CDMO) specifically established to focus on serving companies seeking to develop and commercialise advanced therapy medicinal products (ATMPs). ReciBioPharm's specialised CDMO capabilities include pre-clinical to clinical and commercial development and manufacture for new biological modalities encompassing technologies based on live viruses and viral vectors, live-microbial biopharmaceutical products, nucleic acid-based mRNA and plasmid DNA production.
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.
Sacco System
Sacco System focuses on bacterial manufacturing, research and development for nutraceutical and pharmaceutical fields. Our expertise helps solving consumer needs in more than 110 countries around the world, leveraging on our unique proprietary strains and customised blends. Our know-how is not limited to the lab, but with our two cGMP certified facilities we can support companies through development, process validation, and commercial production.
Capabilities
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.
Scorpius BioManufacturing
Scorpius is a boutique CDMO with a fully operational clinical-scale biomanufacturing facility in San Antonio, Texas. The facility offers ~2,000 sq. ft. of process and analytical development space and ~8,600 sq. ft. of cGMP-compliant cleanroom manufacturing space. Biomanufacturing capabilities include upstream and downstream processing up to 500 L scale for mammalian and cell therapy-based products and up to 200 L scale for microbial-based products.
SGS
SGS supports clients from discovery to clinical development and commercialization through a comprehensive scope of expert-led QC testing solutions for raw materials, APIs and finished products. With a focus on innovation and quality excellence, SGS has vast experience supporting a variety of product types ranging from small molecule products to complex biologics such as proteins, peptides, monoclonal Antibodies, Antibody-Drug Conjugates, Cell & Gene Therapies and more.
Capabilities