FDA's Keith Webber on Setting Specifications

Kloxxado was approved by FDA in 2021 for emergency treatment of opioid overdose, and Emergent also distributes the FDA-approved over-the-counter treatment Narcan.

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.

The transaction adds a pipeline of early-stage drug candidates against high-value targets to Telix’s portfolio, along with other novel targets currently in the discovery stage.

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.

Lonza will develop spray-dried formulations for an intranasally delivered biologic using a reformulated biologic drug candidate for obesity in Iconovo’s pipeline.

Melting point determination using ultraviolet-visible (UV-Vis) spectrophotometry can be used as a sequence-specific method for identifying therapeutic oligonucleotides in pharmaceutical quality control. This method offers a simple, highly selective approach to differentiate between isomers and ensure the integrity of oligonucleotide active pharmaceutical ingredients (APIs) and drug products.