Search results for "competence" in Articles / App Notes

Article Process Chromatography Selection for Downstream Processing Applications
Industry experts discuss best practices for selecting a separation technology. By Caroline Hroncich Process chromatography has changed significantly since it was first introduced to the biop…

Article Biosimilars: Making the Switch Comes with Challenges
More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars. By Sean Milmo The use o…

Article GMP Challenges for Advanced Therapy Medicinal Products
Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task. By Sean Milmo A consultation period…

Article Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed. Jul 01, 2015 By Susan Haigney BioPharm International Volume 28, Iss…

Article Taking a “Development-by-Design” Approach to Cell Therapies
Jun 15, 2015 By Agnes Shanley BioPharm International eBooks Volume 28, Issue 13 Whether outsourcing or developing cell therapies in-house, success demands a focus on quality, c…

Article Biopharma Advances Demand Specialized Expertise
Jun 15, 2015 By BioPharm International Editors BioPharm International eBooks Volume 28, Issue 13 Contract service providers share insights on biopharma market developments and the impl…

Article Advanced Technologies Facilitate Scale-up and Technology Transfer
Single-use and modular technologies plus continuous manufacturing are increasingly important to biopharma scale-up and tech transfer. Jun 01, 2015 By Cynthia A. Challener BioPharm Inte…

Article Biomanufacturing Outsourcing Globalization Continues
However, simply based on the weight of their emerging populations, their growing economic power, and demand for better, cheaper domestic biologics, it is likely that their growing bioprocessing compet…

Article Ensuring the Quality of Biologicals
May 02, 2015 By Stephen Wicks, PhD Pharmaceutical Technology Volume 39, Issue 5 The European Pharmacopoeia (Ph. Eur.), which celebrated its 50th anniversary in 2014, provides common …

Article Continuous Manufacturing: A Changing Processing Paradigm
“Continuous bioprocessing will not just prove to be feasible, but will also become a strategic core competence to therapeutic drug manufacturers. Process speed, tighter quality control, and lower cost…

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