CDMO Avid Bioservices will expand its biomanufacturing services to include viral vector development and production, investing up to $75 million in a California facility.

Biologics contract development and manufacturing organization (CDMO) Avid Bioservices revealed today to build a 53,000 square foot viral vector development and GMP manufacturing facility in Costa Mesa, California at a cost of between $65 million to $75 million.

The facility, which could be operational within two years, will initially support projects up to 200 L using single-use bioreactors in terms of process development activities.  Several projects focusing on viral vector production, purification and in-process testing will be able to be handled in parallel.

Image: iStock/Ravitality

For cGMP manufacturing, the plant will have two production trains that can be performed in parallel offering a similar scale initially, with the capability to increase to 500 L.

“Avid’s decision to expand its service offering into viral vector development and manufacturing is driven by continued strong growth in the cell and gene therapy market combined with the CDMO industry’s overall lack of proven, high-quality GMP manufacturing expertise and capacity for viral vectors,” the company told BioProcess Insider.

“As we conducted our due diligence into the cell and gene therapy market, we consistently heard that there is a shortage of capacity, particularly from suppliers that were flexible and were also able to provide good understanding of quality as it relates to the manufacture of viral vectors, especially as more programs reach late-stage clinical development and product approval.”

From biologics to viral vectors

Avid has more than 16 years of experience in the commercial manufacturing of biologics, and continues building out its facilities nearby in Myford, Tustin. These capabilities and expertise places Avid in in good stead as it turns to viral vector production, the company said.

“Many of the unit operations associated with the viral vector business unit are very similar to our mammalian cell culture (MCC) business, making this a logical next step for Avid,” we were told.

“While we would not categorize the expansion [into CGT] as easy for any CDMO, we do believe that there are several key similarities between viral vector production and the production of biologics such as antibodies and proteins that streamline the process for Avid.  Both follow a process flow based on cell thaw, expansion, building cell mass and producing the desired large molecule. Similarly, chromatography-based approaches are used for purification and removal of contaminants.”

Challenges

However, the firm highlighted current global challenges revolving around the supply chain that may make the expansion more difficult.

“We will not be immune to the universal supply chain shortages that are impacting all sectors related to manufacturing.  With that in mind, we have established excellent relationships with many suppliers for our biologics business and expect these relationships will play a key role in helping mitigate any supply chain issues for the viral vector business.”

The CDMO continued: “Another challenge for Avid will be the building of a team of viral vector sector professionals to execute and oversee our customer’s viral vector projects.  We are already well into the process of staffing up our viral vector team, including leadership and experienced analytic and process development professionals.”