By Vivienne Raper, PhD
The cell and gene therapy industry has not settled on a set of standardized process assays, meaning CDMO Matica Bio must continue to investigate equipment to meet the needs of its clients. The company has purchased a Bio-Rad Droplet Digital
PCR (ddPCR) system for genomic titer measurements. However, according to a company scientist, the his team is still investigating whether to purchase other ddPCR instruments.
“Currently, the industry doesn’t go into details about particular assays and instruments, as they see them as proprietary and a competitive advantage to figuring a problem out without sharing [too much informaiton],” explains Brian Greven, senior director of operations at Matica Bio, who spoke on a panel on cell and gene therapy CDMO selection and external manufacturing best practices at September’s BioProcess International Conference. According to Greven, he sees a need to assess whether Matica Bio should be offering additional process assays to meet the needs of clients.
“I wanted to understand from a gene therapy perspective what are the expectations, whether there’s an industry standard, and what the rationale is behind it,” he explains.
The company, which was officially founded in 2019, says it is working on projects such as development work, QC work, and large-scale GMP production. They are looking to attract new clients, Greven says, and want to have the best process offering.
As with other articles GEN has written about advanced therapies, Greven is concerned that the lack of known standardized methods across the industry is hampering small biotechs, who may end up reinventing the wheel on methodology—at financial cost.
“I [have] worked in the antibody industry for a long time, switching recently to the gene and cell therapy space, and am surprised by [some of the same things GEN journalists are also surprised by].”
The panel discussion also covered the need for CDMOs to have capability to scale up from 1–2 L manufacturing runs for clinical trials, to potentially up to 500 L.
“[Companies] need a good understanding of how the CDMO will transfer that scaleup and what type of data they have on past experiences scaling up,” advises Greven.
He emphasizes the importance of the CDMO having the right equipment and procedures to be able to handle a technology transfer. Matica Bio use Sartorius’ Ambr® bioreactors to provide a variety of scale up options from the same manufacturer. He also recommends that companies choose a CDMO that lets them talk to the scientists—enabling them to interview the entire team that will be working on their project.
The post Advanced Therapy Grapples with Standardized Techniques appeared first on GEN – Genetic Engineering and Biotechnology News.
