Understanding the pharmaceutical lifecycle and the benefits of a menu-driven approach

09 February 2021

FierceBiotech

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:

  • Extensive credentials and compliance with large pharma audits
  • Clinical and commercial manufacturing capability
  • Analytical methods development and qualification/validation
  • Full lot release capabilities
  • Stability testing
  • Drug product testing
  • Process validation support


Current Good Manufacturing Practices (cGMP):

  • Extensive experience leading clients through process validations.
  • Long commercial manufacturing history working with large pharmaceutical organizations.
  • Process performance qualification (PPQ) campaigns completed for 10 projects to date, with the most recent ready for commercial product demand should clients obtain regulatory approval.


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.

  • Assays for IND/BLA Support
  • Assays for Commercial QC Release Support
  • Assays for Upstream and Downstream PD Support

 

Process Development:

  • Discovery Support
  • Upstream Process Development and Optimization
  • Downstream Process Development and Optimization
  • Cell Lines, Molecules, and Production Modes

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