August 10, 2016
Sponsored by Avid Bioservices
Avid Bioservices is a contract development and manufacturing organization (CDMO) specializing in mammalian cell culture process development and CGMP production of clinical and commercial-scale monoclonal antibodies, recombinant proteins, and enzymes. Committed to the success of our clients, our team constantly strives to build partnerships that extend well beyond the delivery of your product. By combining our knowledge and experience with a flexible and efficient approach, we can meet your specific project requirements
Established CDMO with Proven Capabilities
Strong global regulatory inspection track record
Leader in implementing single-use production technologies
Expertise in multiple early clinical-phase biotherapeutics
Commercial supplier for marketed biologics since 2005
Management team experienced in development, product approvals and commercialization
Individualized and dedicated project management team supporting every phase of production — from clone to commercial
Comprehensive analytical capabilities to support lot release and stability studies.
Thought Leadership in Process Sciences
Avid’s expanded process sciences group is focused on the ongoing development and enhancement of process and analytical methods needed to deliver optimized processes for transfer to CGMP manufacturing. Our experience with CHO-based antibody production and our knowledge of recombinant protein and enzyme process development provide the expertise you need to advance your programs to the next phase:
Multiple CHO cell lines developed to produce clinical monoclonal antibodies
CHO cell culture optimization of a phase 2 clinical project, resulting in 5× increase in yield at the 1,000-L scale, with a comparable product
Comparability studies: early-stage, low yield, stainless steel clinical process advanced to high-yield, fully disposable, process (including regulatory and characterization studies)
New State-of-the-Art Facilities for Clinical Development to Commercial Launch
Avid Bioservices recently commissioned its new state-of-the-art commercial biomanufacturing facility in Tustin, California. Its designed to be one of the first late phase 3 and commercial production facilities designed for exclusive operation of single-use equipment to produce biologics in the United States. The 40,000-ft2 facility has completed its initial process validation runs and is ramping up to conduct multiple new process validation runs for a number of clients. The facility is outfitted with cutting-edge, single-use equipment to accommodate a fully disposable biomanufacturing process for late phase 3 clinical and commercial production of biologics. A range of innovative features are incorporated into the new facility, including monolithic modular cleanroom walls, dedicated support utilities for each key processing area, and the industry’s most advanced single-use bioproduction technology, which can accommodate multiple single-use bioreactors up to the 2,000-L scale. Unidirectional process flows separating personnel and materials provide assurance that the design meets the most stringent regulatory requirements for commercial biologic active pharmaceutical ingredient (API) manufacturing. The facility is located adjacent to the company’s current campus in Orange County, California.
Based on significant client demand, Avid is also in the process of designing a third manufacturing facility focused on clinical manufacturing. This additional suite will significantly increase Avid’s manufacturing capacity and is expected to be completed and ready for clinical manufacturing activities by the first half of 2017.
Jon S. Gingrich is manager of business development at Avid Bioservices; [email protected].
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