It's been over eight years since the FDA articulated, in its PAT guidance, the goal of "facilitating continuous processing to improve efficiency and manage variability" in pharmaceutical manufacturing. Since that time there has been a steady development of the concept in the literature. This includes reviews of how and why the industry in general has had difficulty realizing the vision. But, there has been in particular less activity with respect to biopharmaceutical manufacturing — where we have seen very little in the way of systems design, not to mention implementation.
Introducing 3M™ Single-Use Biocontainers from 3M Purification Inc., offering scalable and cost-effective sterilized "Plug 'n Play" solutions for storage, transfer, and process applications in the biopharmaceutical industry. Our single-use biocontainers are available in 2D and 3D versions made from state-of-the-art, coextruded film in a ISO Class 5 cleanroom using medical-grade polymers. They offer exceptional strength, superior barrier properties, and are exceptionally clean. Learn more.
Executive Insights Into Single-Use: Maik Jornitz Of Sartorius Stedim
With nearly 25 years of experience, Maik Jornitz supports the biopharmaceutical industry on a global basis with a focus on validation, optimization, and training in aseptic processing. Jornitz is the author and coauthor of over 100 professional papers, nine books, and nine book chapters, covering presterilizing and sterilizing filtration, integrity testing, single-use technologies, process validation, and qualification.
Increase Production Efficiencies With Single-Use Transfer Lines
Manufacturers across industries rely on innovative technology to meet two critical production requirements: speed and cost-efficiency. Biopharmaceutical manufacturers understand this concept and are implementing new ways to leverage existing plant infrastructure to enhance process reliability and flexibility. One solution that continues to gain momentum is single-use systems — particularly single-use transfer lines — which can deliver significant value through added flexibility, improved asset/equipment utilization, and increased cost savings.
Thank you for reading Bioresearch Online's Single-Use Insights. Do you have a topic you would like to see addressed in future issues, or do you have experience with single-use technology that you could share? Let us know!