August 1, 2013
Avid Bioservices is your CMO partner offering a suite of fully integrated, comprehensive biomanufacturing services that support the development and cGMP production of clinical and commercial-stage monoclonal antibodies, recombinant proteins, and enzymes. Our client’s success is our main focus. With over 15 years of experience, Avid provides services that support every phase of development: cell line optimization, process development, analytical methods development, clinical and commercial cGMP manufacturing, and regulatory support.
As the wholly owned subsidiary of Peregrine Pharmaceuticals, a clinical-stage biotechnology company, Avid manufactures products for Peregrine’s ongoing clinical trials as well as for clients. Our first-hand experience with Peregrine’s clinical products — combined with an accomplished management team in the field of development and commercialization of therapeutic proteins — provides clients with a unique insight into managing the process development, scale-up, and validation challenges of drug development. To date, Avid has produced over 200 cGMP runs in more than 15 different indications.
Dedicated Facility for Preclinical through Commercial Production of Mammalian Cell Culture Biologics: Featuring 2,650 L total capacity — with single-use bioreactors (SUBs), stirred tank reactors (STRs) and stainless steel (SS) bioreactors — Avid’s facility provides clients with flexible manufacturing solutions to meet any project at any phase of production. Our manufacturing experience encompasses clinical to commercial production, including commercial API production since 2005.
State-of-the-Art Automated Filling Services To Be Launched Later This Year: To better serve our clients, Avid is adding automated aseptic fill–finish capability that will support preclinical through commercial-sized batches. With the introduction of this state-of-the-art ASEPTiCell system, Avid clients will benefit from a leading-edge, aseptic, robotic filling system that is fully integrated with a passive restricted access barrier system (RABS). Robotic automation supports filling of vials, syringes, cartridges, and sterile IV bags. With a completely disposable fluid contact tube set, the system is designed for single-use components. Its automation operates with the highest level of efficiency and precision, offering several benefits.
More Vials Filled Per Batch: A short flow path minimizes bulk waste, allowing more vials to be filled. An in-process weight-check verification feature ensures that every vial is within acceptable fill volumes, resulting in fewer rejects due to underfill, overfill, or set-up procedures.
More Precise Fill Volume: Cutting-edge technology allows a fill tolerance of ± 0.01 mL.
Committed to Superior Quality and Customer Service: Avid has a proven track record of quality compliance and customer service. Our lengthy history includes inspections by the US FDA, European agencies, the State of California, and other recognized GMP regulatory agencies in addition to multiple audits by clients each year. Avid is constantly pursuing new ways to optimize processes and methods, to meet the changing needs of our client’s advancing programs. Some of the recent advancements include the following:
Comparability study following a biologics production process from an early stage, low-yield, stainless-steel clinical process to a high-yield, fully disposable, commercializable process (including regulatory and characterization strategies). Our applications of single-use technologies yielded a more efficient upstream process, exemplifying how we have improved our manufacturing flexibility and efficiency using stainless steel and single-use technologies to reduce operational costs and accelerate speed to market.
Quality by design (QbD) approach identifies critical process parameters and makes continuous production improvements that reliably produce a high-quality product for our clients.
Bioassay development expertise supports phase 3 and commercial-stage development programs. This helps evaluate activity and function for monoclonal antibodies developed, qualified, and implemented for lot release and stability testing.
About the Author
Author Details
Kelly Pisarev Lord is manager, marketing communication, at Avid Bioservices, 14282 Franklin Ave., Tustin, CA 92780; 1-714-508-6100; [email protected].
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