By Vivienne Raper, PhD
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.