Biosimilar Development

Guest Column | July 8, 2026 By Mark F. Witcher, Ph.D., biopharma operations subject matter expert CDMOs are a vital part of the pharmaceutical and medical device industries. Building, executing, and maintaining an effective sponsor/CDMO working relationship is critical to developing, commercializing, and manufacturing many important therapies and products.

By Sams M. A. Sadat, Vicente Lacap, Richard Jiang, Zhengyu Chen, Tony Wu, Noorjahan Aibani, Nikita Jain, Jay Paquette, and Anitha Thomas Lipid nanoparticles have become a leading platform for nucleic acid delivery, but their success has largely been confined to the liver after systemic administration. Reaching the lung remains a major hurdle, especially for gene therapies aimed at conditions such as α-1 antitrypsin deficiency, cystic fibrosis, and COPD.

By H. Yazdani, K. Paulson, L. Yee, S. Abbina, H. Son, N. Aibani, and A. Thomas Polyethylene glycol (PEG)–lipids have long been a standard component in lipid nanoparticle (LNP) formulations, valued for their ability to improve colloidal stability, limit aggregation, and extend circulation after systemic delivery. But as LNP-based therapeutics advance, PEG is drawing increasing scrutiny for its potential to trigger anti-PEG antibodies and hypersensitivity reactions, particularly with repeat dosing.

By Jay Paquette, Mehar Gayatri Namala, Leanna Yee, Sams M. A. Sadat, Ruchi Sharma, Darius Menezes, Pierrot Harvie, Nikita Jain, Zhengyu Chen, Malathi Anantha, Tony Wu, Vicente Lacap, Richard Jiang, Vinay Mayya, Sijo Chemmannur, Avisek Deyati, and Anitha Thomas Personalized cancer vaccines are reshaping immunotherapy by training the immune system to recognize neoantigens unique to each patient’s tumor.

Continuous bioprocessing promises greater efficiency, but linking upstream and downstream unit operations into one coordinated workflow remains a major hurdle. While many intensification efforts focus on individual steps, stronger insight comes from seeing how multiple operations work together in practice.

Guest Column | July 7, 2026 A conversation between Prakitr Srisuma and Life Science Connect's Jon O'Connell A new twist on a well-established method, continuous lyophilization approaches are attracting attention because they can improve equipment use, support automation, and reduce the interruptions that complicate process control common in traditional batch methods.

By Bikash Chatterjee, president and CSO of Pharmatech Associates, a USP Company and USP Microbiology Parts 1 and 2 of this series identified the compliance gaps most consequential for Annex 1-compliant environmental monitoring programs and introduced the objective measurement tools, which include standardized recovery reference surfaces, validated inoculum delivery systems, and compendially anchored endotoxin reference standards that can address each gap.

Comparing Process Development Approaches For Recombinant Proteins Explore how adding a traceless tag enables streamlined affinity purification for recombinant proteins, and how this approach compares with a conventional process in development time, recovery, and purity. This article addresses the three contamination control challenges that are specific to the CDMO environment, provides five practical steps any organization can act on now, and more.

Downstream processing has evolved from a hands-on, locally managed function into a highly connected operation shaped by data, automation, and the demands of scale. As biomanufacturing moves across development, pilot, and GMP production, chromatography remains one of the most difficult steps to automate without sacrificing either flexibility or control. Integrated and continuous processing strategies only raise the stakes, making coordination across unit operations more critical than ever.

As adeno-associated virus (AAV) gene therapies advance toward larger patient populations and commercial manufacturing, accurate characterization of viral vector quality has become increasingly important. A key challenge is measuring capsid composition, as AAV preparations contain mixtures of full, empty, and partially filled capsids that can affect potency, dosing, safety, and regulatory acceptance.