Search results for " specification"

Article Microbiological Testing: Time is of the Essence
Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods. By Cynthia A. Challener Effective microbiological testing during biopharmace…

Article Reporting Quality Metrics to FDA
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA. By Siegfried Schmitt Q: We are a contract manufacturing organization (CMO), sp…

Article Platform Approach Speeds Process Development
A modular cell-culture platform demonstrates accelerated process development. By Harald Bradl, Jan Bechmann, Benedikt Greulich, Markus Michael Mueller, Patrick Schulz, Thomas Wucherpfennig C…

Article Lessons Learned Accelerate Vaccine Development
Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing. By Cynthia A. Challener Vaccine development is a complicated process that can take many yea…

Article Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
The necessity to detach cells from a culture substrate during cell harvesting remains one of the most challenging steps in a cell-culture process. By Marcos Simon, Juan J. Giner-Casares Cell…

Article Framing Biopharma Success in 2016
Corporate restructurings, regulatory initiatives, and biosimilars will shape biopharma development in 2016. By Rita C. Peters The US biopharmaceutical industry turned a new page in 2015 when…

Article mAbs to Watch in 2016
By Randi Hernandez Of the 45 new molecular entities and new therapeutic biological products approved by FDA in 2015, nine products were monoclonal antibodies (mAbs). And there may be many more o…

Article Biacore Concentration and Ligand-Binding Analyses
Biotherapeutic drugs including antibodies, cytokines, and hormones are used for treatment of a variety of diseases including arthritis, cancer, and diabetes. Compared to traditional small-molecule dru…

Article Cleaning of Dedicated Equipment: Why Validation is Needed
…otential degradation residues in the equipment was maintained to a minimum and below pre-established specifications. CHT is defined as the time between the completion of cleaning and the beginnin…

Article Quality Systems Key to Lifecycle Drug Management
The goal for OPQ is to ensure that all new and generic drugs meet the quality standards and clinically relevant specifications through pre- and post-approval. Robert Iser, senior scientific advisor in…

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