Manufacturing roundup: Avid Bioservices expands in California; Charles River nets cell therapy production deal

2022-06-16

基因疗法抗体细胞疗法合作

A California-based CDMO will be looking to expand its capabilities in its home state to keep up with market demand. Avid Bioservices is expanding its laboratories in Tustin, California around its capacity for its mammalian cell business. The investment is priced at $6 million, and the 4,500-square-foot expansion is expected to be completed by the end of the year. No outside funds were necessary and the company used cash on hand to fund the project. This expansion tails other investments the company has made to increase process development capacity in 2019 and 2022. Expanding its laboratories could support an additional $20 million in annual process development revenue, doubling the company’s current process development capacity, according to a statement. “Avid is focused on ensuring that it always has available capacity to meet the needs of its customers (current and future),” said Nick Green, CEO of Avid, in an email to Endpoints News. “This latest project will generate additional upstream and downstream process development capacity at the front-end of the mammalian cell business, which is critical for the efficient on-boarding of new customer projects.” This comes on the heels of Avid opening an analytical and process development suite within the company’s cGMP manufacturing facility. The launch of these is to expand its CDMO service offering into the rapidly growing cell and gene therapy market, with the company looking to fulfill those capabilities in 2023. Massachusetts-based Charles River Laboratories and ASC Therapeutics, a privately held biopharma that specializes in gene therapies, have agreed to manufacture ASC618, a gene therapy for hemophilia A. Financial details and a timeline of the arrangement were not disclosed. Kerstin Dolph, SVP for biologics solutions management at Charles River, said that the company has been working with ASC since 2019, to help establish a manufacturing process for their preclinical research. Together both companies have established a process for AAV8 production. Dolph also said that the plasmid manufacturing and testing, GMP-upstream and -downstream processes, and the fill/finish for ASC are happening at their facility in Rockville, MD. After acquiring Pfizer-owned Hospira Adelaide , the San Diego CDMO BioCina has expanded its service offerings to include the manufacture of plasmid DNA (pDNA) in a new GMP suite. While no financial or size details were presented, the suite is now open and has up to 300 L single-use fermentation capacity and scaled downstream processing equipment to complement their manufacturing capabilities. “With our extremely strong history of quality in manufacturing, an exemplary regulatory inspection history, and our customer-centric business approach, BioCina is in a strong position to add significant value to companies working in the RNA and gene and cell therapy space that are struggling to find reliable and collaborative outsourcing partners,” said BioCina CEO Ian Wisenberg. According to the company, its decision to expand its service offering into pDNA development and manufacturing was driven by the demand for GMP-grade pDNA. Swiss drug manufacturer Lonza and French pharmaceutical group Pierre Fabre announced on Wednesday that the companies have entered into a manufacturing agreement. While no financial details were revealed, the collaboration will be centered around manufacturing W0180, a monoclonal antibody discovered by Pierre Fabre targeting the VISTA checkpoint. The asset is being investigated as a single agent and in combination with pembrolizumab in Phase I clinical trial in various solid cancer tumors. The deal will have Lonza provide cGMP drug product manufacturing services for clinical supply from its fill and finish facility in Stein, Switzerland. Lonza has been on the move across the globe recently, as it has not only recently collaborated with a VC in Israel, but has also completed a manufacturing facility in Bend, Oregon.

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