Nonprofit standards organization, U.S. Pharmacopeia (USP), has given a talk as part of efforts to raise awareness of its standards for biologics including mAbs and vaccines. USP, which aims to build trust in medicines through public quality standards, says that many small biotechs—especially—are unaware of how standards can de-risk their manufacturing.
“We have an outreach program now to small biotechs,” explains John Kokai-Kun, PhD, director, collaborations, and partnerships, biologics at U.S. Pharmacopeia. “A lot of great innovations come from them, but [financing] is currently tight and they can’t afford to make mistakes so we’re [making them aware] we have [potentially helpful] solutions.”
Kokai-Kun spoke about U.S. Pharmacopeia’s documentary and reference standards, and analytical reference materials at the September 2023 BioProcess International Conference. According to Kokai-Kun, the organization offers an online guide to mAb analytics, which includes documentary standards, educational resources, and ten physical reference standards.
These include USP’s first analytical reference material, a recombinant Phospholipase B-like 2 protein (PLBL2). This, he says, can be used to check that host cell protein (HCP) assays used in mAb manufacturing can detect PLBL2, which often co-purifies with mAb drug products where it acts as a contaminant.
USP is also in the process of collaborating with National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) to develop best practices for adeno-associated virus (AAV) and other common materials used in gene and cell therapy.
“Cell and gene therapy is a growing area in biologics,” says Kokai-Kun. “But it’s also a wild west with people doing something as simple as [assessing] full-versus-empty capsids in multiple different ways.”
A third recent area of activity is in vaccine quality assessment toolkits, with toolkits available for mRNA, viral vectors, and inactivated vaccines, with a toolkit relating to virus-like particles added last year.
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PackGene is a CRO & CDMO technology company that specializes in packaging recombinant adeno-associated virus (rAAV) vectors. Since its establishment in 2014, PackGene has been a leader in the AAV vector CRO service field, providing tens of thousands of custom batches of AAV samples to customers in over 20 countries. PackGene offers a one-stop CMC solution for the early development, pre-clinical development, clinical trials, and drug approval of rAAV vector drugs for cell and gene therapy (CGT) companies that is fast, cost-effective, high-quality, and scalable. Additionally, the company provides compliant services for the GMP-scale production of AAVs and plasmids for pharmaceutical companies, utilizing five technology platforms, including the π-Alpha 293 cell AAV high-yield platform and the π-Omega plasmid high-yield platform. PackGene's mission is to make gene therapy affordable and accelerate the launch of innovative gene drugs. The company aims to simplify the challenging aspects of gene therapy development and industrialization processes and provide stable, efficient, and economical rAAV Fast Services to accelerate gene and cell therapy development efforts from discovery phase to commercialization.
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