Outsourcing Outlook

Intravenous administration of amivantamab is the currently approved route, but a Phase III trial showed that subcutaneous treatment was non-inferior.

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.

In a peer-reviewed study, Lantern Pharma said its AI-driven approach successfully identified 82 promising ADC targets, and 290 target-indication combinations.

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.

Prior to this announcement, Rentschler announced in September 2024 it would be launching an expanded service offering at its advanced therapies site in Stevenage, UK, which is now being shut down.

The UK MHRA has granted approval for garadacimab for use in preventing angioedema attacks in patients 12 years old and older who have hereditary angioedema.