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.
Filter Sizing for Process Optimization in Life Sciences Sterile Filtration
April 24th 2025Bench-scale filterability studies play a critical role in optimizing sterile filtration in biopharmaceutical manufacturing. By guiding the selection and sizing of filters, these studies help streamline processes, improve scalability, and reduce costs. Through data-driven case studies, this paper highlights how the strategic use of pre-filters and membrane materials can maximize throughput and minimize filter fouling.
Ensuring Biologic Stability with Tailored and Cutting-Edge Lyophilization Solutions
April 14th 2025Explore how tailored lyophilization solutions, integrated with quality-by- design principles and advanced modeling, help optimize stability, reduce costs, and enhance global accessibility for biopharmaceuticals.
Top 10 Cleanroom Problems That Can Be Prevented via Preventative Maintenance
April 14th 2025Cleanrooms require strict environmental control to maintain sterility, prevent contamination, and ensure seamless operations. Without a proactive preventative maintenance (PM) program, various issues can arise, leading to costly downtime, contamination risks, and operational inefficiencies. Below are ten common cleanroom problems that can be effectively mitigated through proper PM practices.
