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.
Check out our mRNA service to expedite your vaccine research
Source: https://www.genengnews.com/topics/bioperspectives/u-s-pharmacopeia-raises-awareness-of-biologics-standards/
PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a sharp focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution.
Related News
NeuExcell Therapeutics Unveils Breakthrough in Stroke Treatment at ASGCT 2024
In a groundbreaking development, NeuExcell Therapeutics has revealed a significant breakthrough in its NXL-001 product for stroke treatment. The announcement was made at the 2024 American Society of Gene and Cell Therapy (ASGCT) Annual Meeting, where the company...
Unraveling CRISPR Precision: BreakTag Illuminates Pathways to Improved Gene Editing
Introduction:The quest for precision in CRISPR-Cas9 gene editing takes a significant leap forward with the development of BreakTag, a method devised to enhance our understanding of DNA double-strand breaks (DSBs) induced by Cas9. This breakthrough, detailed in a...
Sumitomo Pharma Announces FDA Acceptance of Supplemental New Drug Application for Vibegron in Men with Overactive Bladder Symptoms Receiving Pharmacological Therapy for Benign Prostatic Hyperplasia
–Supplemental New Drug Application (sNDA) submission based on Phase 3 study of vibegron 75mg (GEMTESA) demonstrating statistically significant reductions in daily micturition and urgency episodes– –If approved, vibegron will be the first and only beta-3 agonist for...
Herpes cure with gene editing makes progress in laboratory studies
Herpes simplex virus. Credit: CDCResearchers at Fred Hutch Cancer Center have found in pre-clinical studies that an experimental gene therapy for genital and oral herpes removed 90% or more of the infection and suppressed how much virus can be released from an...
Related Services