Manufacturing

Articles

Innovative polyethylene film sets new benchmark

Sartorius Stedim Biotech Launches New Generation of Single-Use Bags, Flexsafe

Bioreactor for Mammalian Cell Culture

What challenges do biopharmaceutical manufacturers face when deciding to move from a fed batch process to a continuous process?

Continuous Bioprocessing Challenges

Mark Leykin is senior validation engineer, EMD Millipore.

Andrea Detroy is head of QC packaging materials projects, Medical Devices & Disposables, Roche Diagnostics GmbH, Mannheim, Germany.

Christian Matz is global project manager, Biologics Manufacturing Science and Technology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.

Ross W. Acucena is regulatory consultant, Provantage Services, EMD Millipore

Application of single-use technology in a parenteral facility for syringe filling.

Single-Use Technology in Parenteral Fill/Finish

Catalent's Advasept platform uses blow-fill-seal technology to aseptically manufacture, fill, and seal a polymeric primary container for injectable drugs.

Advanced Aseptic Technology Provides Glass-Free Delivery of Injectable Drugs

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Both upstream and downstream processes can benefit from continuous manufacturing advantages.

Advances in Continuous Biopharmaceutical Manufacturing

Higher antibody titers and a growing demand for smaller-volume, flexible processes are creating the need for more cost-effective downstream processing.

Increased Efficiency Key to Competitiveness in Downstream Bioprocessing

Automated sample handling, advanced glycan analysis, and specially designed columns are help speed up confirmation of the biosimilarity.

Advances in UPLC Techniques and Column Chemistry Aid the Confirmation of Biosimilarity

John Schmitz, director of strategy and business development, life sciences, Saint-Gobain Performance Plastics.

Consider these best practices when deciding to implement single-use components.

Selecting Single-Use Systems for Biopharmaceutical Manufacturing

Eric Langer has over 25 years experience in biotechnology and life sciences strategic marketing management, market research, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He has published and authored many books and reports on topics in Biotechnology, Large-scale BioManufacturing, and bioscience commercialization and communication. He teaches at Johns Hopkins University marketing management, biotech marketing, services marketing, and marketing in a regulated environment. In 1989 he co-founded BioPlan Associates, Inc. to provide market analysis, and strategy to biotech and healthcare organizations.

Data from BioPlan Associates’ 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production suggest that the interest in disposable devices has begun to extend to biopharma operations beyond basic single-use bags and connectors.

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