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Navigating the Analytical Development Challenges for Bioprocess Residuals and...
To ensure the safety and efficacy of biopharmaceutical products administered to patients, manufacturers are expected to measure and control impurities in their products, including the host cell...
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Introduction to Bioprocessing Training Seminar
Drs. Sheila G. Magil, Senior Consultant, and Frank Riske, Senior Consultant, will be leading CHI’s Introduction to Bioprocessing training seminar during PepTalk to be held from January 18-22, 2016 in...
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With Start-Up Biotechs, First-in-Human Trumps Quality by Design (QbD)
By Susan Dana Jones (sjonesbptccom) According to the 2011 FDA Guidance for Industry on process validation and 2012 EMA process validation guideline, process design and understanding should begin as...
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Supercharged T-Cells Battle Cancer But Will GxP Compliance Be Their Kryptonite?
By Sheila G. Magil (smagilbptccom) What if your company had to sign off on hundreds of unique product batch releases a year; each a therapeutic for a specific individual, and where a “mix-up” could...
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Raw Material Testing: When is Enough, Enough?
by: Joe Siemiatkoski (jsiemiatkoskibptccom) The CaSSS WCBP (Well-Characterized BioPharmaceutical) conference focusses on addressing issues at the interface of analytical development and global...
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Biosimilars, Clinical Studies and Analytical Similarity Summit
Joseph Siemiatkoski, Consultant will be attending Biosimilars, Clinical Studies and Analytical Similarity Summit to be held at the Hyatt Regency Boston from March 21-23, 2016. If you’re interested in...
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