Leveraging Post-Translational Modifications Biofunctional Assays For The Characterization Of Charged Variants
The manufacture of protein-based drugs is complex and relies on using biological host systems. This can result in small changes in protein structure during production and formation of protein variants that can have a large impact on functionality. This heterogeneity — variations in the protein size, charge or structure — can significantly impact the safety and activity of the final biotherapeutic or biosimilar therapy, potentially hindering their beneficial effect. It is vital that charged variant profiles of biologics are adequately characterized, as many post-translational modifications (PTMs) may alter the charge of the molecule, in turn impacting its stability, pharmacokinetics and pharmacodynamics. In this article, Catalent explores protein variants, focusing on charged variants, by outlining their impact on protein-based drugs, and explain how specific characterization techniques can be used to determine product safety and efficacy.
Oligonucleotide Analysis in Pharmaceutical Quality Control
January 14th 2025Melting 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.
Keeping Up With Emerging Analytical Technology
January 9th 2025There are several advantages to using a novel capillary electrophoresis-mass spectrometry (CE-MS) device. The REBEL from 908 Devices offers a streamlined and efficient alternative to traditional liquid chromatography-mass spectrometry (LC-MS) for bioprocess monitoring. This paper highlights how this new technology can simplify media analysis, reduce method development time, and improve real-time data collection for biotherapeutic production.
Cell Density Applications eBook (Jan 2025)
January 8th 2025The eBook features must-see examples of real applications using Hamilton viable cell density monitoring (Incyte) and total cell density monitoring (Dencytee) and demonstrates how to leverage Viable Cell Density Monitoring in your processes.
White Paper: The PAT Pathway to Scalable and Sustainable Precision Fermentation
January 8th 2025Precision fermentation, a sustainable method for producing alternative food ingredients, faces significant technical challenges. This white paper explores the critical role of Process Analytical Technology (PAT) in overcoming these hurdles and ensuring product quality through a Quality-by-Design (QbD) approach. Through a comprehensive review of literature and case studies, key technical challenges are identified to demonstrate how PAT can enhance scalability and sustainability. This paper also highlights the transformative potential of PAT in advancing precision fermentation as a reliable solution for addressing nutritional deficiencies and fostering a circular economy.
