Search results for " monitoring" in Articles / App Notes

Article Platform Approach Speeds Process Development
…ration sequencing, combined with further improvements in media, high-throughput technologies, online monitoring, and automation, will allow enlargement of the experimental design space, but will also…

Article A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells. By Luhong He, Christopher Frye Abstract …

Article Innovative Therapies Require Modern Manufacturing Systems
FDA and industry see progress and challenges in bringing cutting-edge medicines to patients. By Jill Wechsler FDA set a 19-year record in 2015 in approving more new drugs and biologics, and …

Article CMOs Continue to Improve Overall Biomanufacturing Performance
Better process development is creating industry benchmarks for bioprocessing. By Eric Langer Biomanufacturing efficiency is on everyone’s minds, being the single most important area of focus…

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 USP Stresses Pharmacopeial Standards at CPhI China
Topics included global harmonization with industry standards and regulations, compliance monitoring, and accountability. The USP requirements for elemental impurities, FDA’s metrics program, and the g…

Article Biopharma Advances Demand Specialized Expertise
BioPharm: What additional technology improvements are needed to improve the efficiency of bioprocessing? Lorimer (Patheon Biologics): Process analytical technology (PAT) for continuous monitoring o…

Article Modular Manufacturing Platforms for Biologics
May 01, 2015 By Randi Hernandez BioPharm International Volume 28, Issue 5 It should come as no surprise that the good design principles governing the execution of pharmaceutical manu…

Article Drug Discovery and Development in India
Apr 01, 2015 By Jane Wan BioPharm International Volume 28, Issue 4 Indian pharmaceutical companies’ entry into the drug discovery and development field dates back to the early 1990s …

Article The Bullish Outlook for Biosimilars
Feb 01, 2015 By Jill E. Sackman, PhD, Michael J. Kuchenreuther, PhD BioPharm International There are several important reasons for stakeholders to be optimistic about prospects for b…

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