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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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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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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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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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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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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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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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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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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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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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DCAT Week 2014
Patti Seymour, Senior Consultant, will be presenting at Drug, Chemical & Associated Technologies Association (DCAT) Week 2014 to be held in New York City from March 10-13. Patti’s presentation on...
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Once Again, Lack of SOP Compliance Tops List of 483 Observations
By Alex Kanarek (akanarekbptccom) and Howard Levine (hlevinebptccom) On January 15, FDA published its annual summary of inspectional observations for the period October 2102 – September 2013. Out...
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2nd Annual Quality Assurance in Pharmaceutical Manufacturing Conference
Join Dr. Sheila Magil (smailbptccom) , Senior Consultant, at the 2nd Annual Quality Assurance in Pharmaceutical Manufacturing Conference to be held from May 20-21, 2013 in Alexandria, VA. To...
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Second Biosimilar Infliximab Submitted to EMA for Approval; Teva Halts...
Patti Seymour (pseymourbptccom) and Howard L. Levine (hlevinebptccom) In late September, a second biosimilar version of Remicade® (infliximab) was submitted by an unnamed company to the EMA for...
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European Commission Finally Publishes Changes to GMP Guidelines
By: Patti Seymour (pseymourbptccom) , Alex Kanarek (akanarekbptccom) , and Sheila Magil (smagilbptccom) Almost two years after the initial changes were proposed, the European Commission (EC)...
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