Manufacturing

Feliza Mirasol is the science editor for 

Articles

Aseptic fill/finish of biopharmaceuticals requires an understanding of the structure and limitations of each molecule.

Understanding Molecule Sensitivity in Aseptic Fill/Finish

Dayna Turner is group leader, Science & Technology, at STERIS, Saint Louis, Mo.

Dijana Hadziselimovic is laboratory manager, Technical Services, at STERIS, Saint Louis, Mo.

Paul Lopolito is a technical services specialist at STERIS, Mentor, OH.

Mary Schanne is senior account manager at STERIS, Saint Louis, Mo.

Amy Thanavaro is manager, Science & Technology, at STERIS, Saint Louis, Mo.

Jeff Felker is deputy director, Cleaning Validation SME, Sanofi MSAT Swiftwater, Pa.

In this article, the authors explored the elimination of a water rinse and blow down following the caustic wash step, examining potential safety considerations, the effect on the quality of the cleaning process, and the potential benefit of implementing this change.

Strategic Changes to a Legacy Cleaning Approach Result in a More Sustainable Process

Editor of Pharmaceutical Technology Europe

Videos

At CPHI Milan, Zaim Gashi, area sales manager of Steriline, discussed the evolution of aseptic processing equipment to stay compliant with current regulations.

Discussing the Evolution of Aseptic Processing Equipment for Regulatory Compliance (CPHI Milan 2024)

Cynthia A. Challener, PhD, is a contributing editor to BioPharm International.

Gamma irradiation is being supplemented with alternative technologies.

Sterilization Trends for Single-Use Consumables

Novo Nordisk plans to invest $4.1 billion in a second fill/finish manufacturing facility in Clayton, N.C., boosting its current 2024 investments into production to $6.8 billion.

Novo Nordisk Targets $4.1 Billion Expansion of US Manufacturing Capacity 

Technological advances are aiding manufacturers to streamline aseptic processes and improve time-to-market.

Speeding Up Aseptic Processes

BioPharm International® spoke with Jeff Clement, executive director of Technical Sales for Development and Manufacturing Group at PCI Pharma Services, about the challenges and benefits of incorporating robotics into aseptic manufacturing

BIO 2024: Robotics in Sterile Processing

Vincenza Pironti, PhD,is strategic marketing director at Recipharm.

The rising demand for biologics and technological innovations are driving blow-fill-seal capacity, harnessing manufacturing efficiency, and benefitting patients.

Leveraging Blow-Fill-Seal Technology for Biologic Delivery

Sterile filtration and use of sterile single-use materials provide the best solutions depending on vector size.

Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges

At INTERPHEX 2024, BioPharm International spoke with Mary Van Gaasbeck, technical services specialist, LS Equipment and Services, at STERIS Life Sciences, about how to effectively conduct sterile powder transfer during the fill/finish step in parenteral drug product manufacturing.

Manufacturing, Aseptic Processing