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.
The Role of On-Demand Manufacturing and Derisking in Accelerating Early Clinical Trial Success
June 4th 2025Small pharmaceutical companies are constantly seeking innovative solutions to streamline early clinical trials. Adaptive clinical trials offer important benefits to sponsors and patients, both from a commercial and ethical standpoint. These trials offer flexibility and efficiency, especially in the early stages, where trial protocols can be adjusted based on interim data, such as introducing new doses or modifying participant sample size. However, adjusting manufacturing demand during an adaptive trial can be complicated, and strict regulatory requirements present significant challenges. On-demand manufacturing provides a robust solution, allowing for real-time supply and demand adjustments and improved trial flexibility. This paper explores how on-demand manufacturing meets the operational needs of adaptive trials and aligns with regulatory expectations.
Top 10 Cleanroom Problems That Can Be Prevented via Preventative Maintenance (May 2025)
May 16th 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.