Search results for " manufacturing processes"

Article Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015 By Randi Hernandez BioPharm International Volume 28, Issue 4 Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …

Article Modular Manufacturing Platforms for Biologics
According to Pär Almhem, president of ModWave, modular design and construction in pharmaceutical process facilities can include either breaking a facility and its manufacturing processes into function…

Article Assessing Manufacturing Process Robustness
…ecisions for the product as well as to identify areas where QbD development should focus for similar manufacturing processes/products. The Stage 3a monitoring measures are developed in line with upco…

Article Continued Process Verification for Biopharma Manufacturing
The authors discuss complications of implementing continued process verification and provide recommended approaches. Oct 1, 2014 By: Jeff Fleming, Robin Payne BioPharm International …

Article Strategizing for Rapid Changeovers in Biologics Manufacturing
Olivier Le Moal/Stock.Adobe.com By Cynthia A. Challener  Facility and equipment design are important, but the team and its experience matter most. Through its Operation Warp Speed pro…

Article Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
Innovative approaches, including ready-to-use materials and in-line dilution, can significantly streamline overall bioprocessing operations.   By: Pranav Vengsarkar and Nandu Deorkar I…

Article Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …

Article Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The authors review efforts to limit polymer degradation without significantly impeding cell growth. Jan 01, 2015 By Sara Ullsten, Shujian Yi, Jeffrey Carter, Eva Lindskog, Pokon Ganguli, Her…

Article Contract Manufacturing Through the Years
Contract Manufacturing Through the YearsHow has the bio/pharmaceutical contract manufacturing industry evolved over the years and what does the future hoHow has the bio/pharmaceutical contract ma…

Article Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Price pressure on biosimilars has driven trends toward more cost-effective manufacturing processes, such as single-use technologies, throughout the biopharmaceutical industry. One counterintuitive tre…

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