Bioprocessing and Sterile Manufacturing

May 01, 2014
By Pharmaceutical Technology Editors

Pharmaceutical Technology’s Bioprocessing and Sterile Manufacturing e-book examines emerging trends in the development and manufacturing of parenteral and biologic drugs, including continuous manufacturing, monitoring, steriilzation procedures, modular manufacturing, and single-use technologies. This e-book format includes videos, interactive functionality, and links to additional resources.

--The editors of Pharmaceutical Technology

View Pharmaceutical Technology's Bioprocessing and Sterile Manufacturing eBook

Continuous Manufacturing
Potential Benefits Drive Interest in Continuous Manufacturing
Players across the biologics value chain are attracted by the advantages of continuous biopharmaceutical manufacturing.

by Cynthia A. Challener

Video Interview
Continuous Bioprocessing Challenges
What challenges do biopharmaceutical manufacturers face when deciding to move from a fed batch process to a continuous process? Stéphanie Dubois, cell culture laboratory manager and application specialist at Pall Life Sciences, describes challenges and explains how alternative types of perfusion bioreactors can simplify the process.

Continuous Monitoring
Achieving and Maintaining Compliance Using Continuous Monitoring Systems
There are a number of challenges when implementing a continuous monitoring system. The author presents issues encountered at Novo Nordisk and discusses how expanding the scope of monitoring, together with frequent and thorough review of data, can help keep a facility in compliance.

by Asbjørn Jensen, Novo Nordisk

Cross Contamination
Determining Cross-Contamination Risks in Multiproduct Biopharmaceutical Facilities
A global contract manufacturer of biologics discusses the increasing impact of health-based exposure limits in assessing cross-contamination risks.

by Cynthia A. Challener

Sterilization of Liquids
Optimizing the Sterilization of Liquids in Sealed Containers
Establishing a sterilization process for liquids in containers involves trial and error, as pressure adjustments must be made during the heating, sterilization, and cooling phases. An alternate approach—cycles controlled by differential pressure—maintains the pressure in the chamber at a level that prevents the rigid containers from exploding and the non-rigid containers from becoming deformed.

by Jordi Net, Telstar

Protein Oxidation
Determining Protein Oxidation Induced During Fill-Finish Operations
Residual hydrogen peroxide (HP) from the vapor-phase HP (VPHP) isolator decontamination process can diffuse into drug product, potentially resulting in significant protein oxidation and thus impacting product quality. The effect of absorbed VPHP on a lyophilized product Protein Z, was studied by spiking experiments with different amounts of hydrogen peroxide and the stability of the lyophilized product was studied for up to six months.

by Sangeeta Benjwal, Mark Yang, Arun Jangda, Anders Lund, and Konstantin Konstantinov; Genzyme

Video Interview
Using Modular Systems in Biopharmaceutical Manufacturing
What is a modular system and how are modular systems being used in the biopharmaceutical industry? Pär Almhem, president of ModWave, gives his perspective on modular systems.

Single-Use Technology in Parenteral Fill/Finish
Application of single-use technology in a parenteral facility for syringe filling.

by Dr. Andrea Detroy, Roche Diagnostics GmbH; Dr. Christian Matz, F. Hoffmann-LaRoche Ltd,; and Mark Leykin, Ernest Jenness, and Ross W. Acucena, EMD Millipore



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