09 February 2021
All pharmaceutical products begin with an idea, followed by an array of complex steps required to bring the results of that idea to the commercial market.
The concept of one-stop shopping has become more popular in the biopharmaceutical industry in recent years, prompting many traditional commercial manufacturing organizations (CMOs) to provide support to clients throughout the manufacturing lifecycle.
“Growth of the full-service contract and manufacturing organization (CDMO) market has enabled a paradigm shift from early biotechnology companies that wanted to become ‘fully integrated pharmaceutical companies’ to today’s nimble, lean, and sometimes virtual companies,” noted BioProcess International in 2016.1
Avid Bioservices, Inc, (NASDAQ: CDMO) a clinical and commercial CDMO based in Tustin, CA, has also evolved from a biologics development and manufacturing firm in 1993 into the full-fledged CDMO it is today.
Meanwhile, the company has established an exemplary regulatory global track record for biotherapeutics, with approved products marketed around the world. The company uses state-of-the-art technology throughout their process development laboratory, as well as both of their CGMP manufacturing facilities. They utilize both stainless steel and single-use bioreactors ranging in scale from 100L to 2000L.
Avid received 5 CMO Leadership awards in 2020 and has been named as one of the Forbes 2021 America’s Best Small Companies.
Menu-Driven Service Offerings
What makes Avid truly unique, however, is its menu-driven service offerings. This approach allows early phase clients to establish a relationship with Avid early in the process. Likewise, late-phase clients know that their chosen CDMO has the experience to develop other projects within their pipeline.
Additional advantages to Avid’s menu-driven approach include the following:
As such, clients can avoid the pitfalls of an all-or-nothing contract. For example:
“When you narrow your choices, there are probably few companies with the commercial experience we have in the United States and with excess capacity. That’s what we’ve heard from customers who’ve done due diligence before reaching out to us.” -Timothy Compton, chief commercial officer at Avid Bioservices
Avid Bioservices has the experience, flexibility, and dedication to allow clients to mix and match the services needed at a given time, plus the opportunity to build on that framework in the future.
“In my experiences across multiple projects, I have found Avid Bioservices to be flexible, pragmatic, collaborative, and trustworthy. Avid has an excellent regulatory compliance track record, a result of efficient and well-integrated Quality Systems. Avid’s Project Management function provides a solid foundation for planning and communication which have effectively advanced my client’s programs through the challenges inherent to biologics development to successful project endpoints. I highly recommend Avid Bioservices.” - Biologics CMC Consultant
Quality and Regulatory Compliance:
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Current Good Manufacturing Practices (cGMP):
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Analytical Services: Multidisciplinary analytical experts will design an agile analytical program that will adequately characterize a client’s product to meet phase appropriate regulatory guidelines, from early-phase to commercial.
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Process Development:
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