Search results for " monitoring"
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
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Poster
Modes of controlling charge variant distribution in Mab production
The characteristics of a biological drug, for example, charge variant profile, are determined to a large extent by the upstream expression system and conditions, but can also be influenced by the pu…
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 …