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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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Is the TPP for your IND MIA?
By: Al Doig (adoigbptccom) and Taylor Burtis (tburtisbptccom) You are a small to mid-size biotech company with a molecule you believe has efficacy for the treatment of one or more human disease...
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PepTalk 2015
Drs. Susan Dana Jones (sjonesbptccom) and Sheila Magi (smagilbptccom) l will be leading a 1.5-day training course titled, “Introduction to Bioprocessing” from January 19-23, 2015 at the Town and...
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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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Breakthrough Therapy Designation-Not Necessarily a Slam Dunk
Accelerating your CMC Timeline By: Patti Seymour (pseymourbptccom) Breakthrough therapy (BT) designations have been receiving much attention since the Advancing Breakthrough Therapies for Patients...
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QbD Leads to Breakthrough Therapy Jackpot
by: Andreas Woppmann, Ph.D. (awoppmannbptccom) Is your innovative biotech medicine a Breakthrough Therapy? If it treats a serious disease, fills an unmet medical need and demonstrates substantial...
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Biobetters Need a Definition!
By: Joe Siemiatkoski (jsiemiatkoskibptccom) The Biosimilars Clinical Studies & Analytical Similarity Summit held in Boston from March 21-23, 2016 covered a broad range of topics ranging from...
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BIO International Convention 2016
Title: BIO International Convention 2016 Location: San Francisco, CA. Description: Join BPTC at the annual BIO International Convention 2016 in beautiful San Francisco, CA from June 6-9, 2016 to...
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FDA Doubles Down on QbD
by: Brendan Cooney After a 13 year gap the US FDA has updated its guidance on Comparability Protocols bringing it in line with contemporary thinking on modern pharmaceutical development practices. So...
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Quality by Design (QbD): Seeing the Glass as Half Full
by: Brendan Cooney As the biopharmaceutical manufacturing industry grows and becomes global, companies face demands to improve quality, while reducing costs and increasing output. The road to achieving...
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