21 CFR Part 11: (Un)Expected Added Value

Contract development and manufacturing organizations (CDMOs) are more critical than ever as the demand for advanced therapies continues to grow.

In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.

Application Notebook highlighting Liquid Chromatography techniques commonly used for monitoring Critical Quality Attributes (CQAs) in Bioprocessing Applications

Metabolic Flux Analysis (MFA) is a powerful technique used to characterize metabolic phenotype driving to improved productivity in biomanufacturing. MFA is most powerful when absolute concentrations of the metabolic intermediates are measured, but doing so in practice is often impractical due to inherent limitations of conventional absolute quantitation by mass spectral analysis. Recently, advances in artificial intelligence (AI) have been applied to solving the problem of broad, untargeted, absolute quantitation in liquid chromatography-mass spectrometry (LC-MS). These new approaches extend readily to the determination of absolute concentrations of stable isotopically-labeled metabolic intermediates, offering a new tool for MFA. Dr Sam Yenne from Metalytics Inc., a company that specializes in the science of metabolic flux, has recently assessed and adopted Pyxis, a new tool for absolute quantitation of raw LC-MS data. Dr Yenne describes MFA, its utility in biopharmaceutical development, associated challenges and how Pyxis impacts those challenges.

The company has formed Scinai Bioservices Inc., new US-based subsidiary operating out of Delaware that will serve biotech companies in early stage drug development.

This article looks at how the MAPPs assay works, how it integrates with other immunogenicity assays, and just how it can be flipped to help in vaccine design.