Biologic Drug Product Sourcing Center
Biological products range widely from allergenics, blood components, gene and cell therapy, recombinant therapeutic proteins, vaccines, etc.
Products are composed of various substances, and isolations from natural sources - human, animal, or microorganism – can be produced and characterized by advanced technologies and methods. Aseptic facilities and special equipment are often required, in contrast to most conventional (small-molecule) drugs. And with the growing demand for cell and gene, and other biologic expertise to advance cutting-edge science and programs, drug product development and manufacture will continue to be in great demand.
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Biologic Drug Product CMOs
AGC Biologics
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) committed to delivering the highest standard of service and collaboration to our clients and partners as we work side-by-side to help bring their products to patients across the globe. We offer world-class development and manufacturing services of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA) viral vectors, and genetically engineered cells.
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
Ascendia Pharma
Ascendia Pharmaceuticals is a specialty pharmaceutical CDMO that provides custom sterile- and non-sterile-enabling formulations and manufacturing, along with analytical methods for new chemical entities, complex dosage forms, and 505(B)(2) product development, as well as OTCs, nutraceuticals, and animal health.
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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
Charles River
For over 70 years, Charles River has provided essential products and services to help pharmaceutical and biotechnology companies, government agencies, and leading academic institutions around the globe, helping to accelerate their research and drug development efforts. With over 90 sites globally, we're ready to tackle your product's most unique challenges.
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.
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.
INCOG BioPharma Services
INCOG has been designed and built from decades of experience with a clear purpose: to deliver better CDMO services in the injectable drug product space. The company's service offering includes filling drug product into vials, syringes, and cartridges. INCOG also offers support services to include formulation development, analytical development, stability testing and storage, and final inspection, labeling, packaging, and device assembly.
KBI Biopharma
KBI Biopharma, Inc., a JSR Life Sciences company, is a leading global CDMO providing fully integrated, accelerated drug development and biologics manufacturing services and expertise to life science companies. Built upon a foundation of world-class analytics capabilities and extensive scientific and technical expertise, KBI delivers robust process development and clinical and commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs.
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.
MilliporeSigma
We have established synergy between production and testing within one company supporting early development through commercial production, proven FDA/EMA compliant quality systems for commercial release of approved products, and a history of successfully navigating the commercial regulatory pathways.
Capabilities
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.
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.
PCI Pharma Services
PCI Pharma Services is an integrated full service provider, a proven and trusted partner to leading companies in the global healthcare industry. We offer unparalleled expertise and experience in taking compounds from the earliest stages of development through to successful commercialization, delivering speed-to-market and commercial success for our customers.
Pfizer CentreOne
Pfizer CentreOne is a global CDMO embedded within Pfizer and a leading supplier of specialty APIs.
Working together with our customers, we combine our knowledge with open dialogue to solve challenges.
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.
Simtra BioPharma Solutions
Simtra BioPharma Solutions partners with pharmaceutical and biotech companies to support their commercialization objectives by providing scientific expertise, sterile contract manufacturing solutions, and customized support services needed to meet the unique challenges that parenteral products face.
Singota Solutions
Specializing in small batch aseptic fill/finish of vials, syringes, and cartridges, Singota Solutions is focused on moving products through the drug development pipeline faster—with agility, accountability, and transparency.
Societal™ CDMO
Societal™ CDMO is a bi-coastal CDMO with capabilities spanning pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms with a primary focus in small molecules. With an expertise in solving complex manufacturing problems, Societal is a leading CDMO providing therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market.