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02.16.21 -- Do These Recent Warning Letters Signal A Shift In FDA Enforcement?


02.16.21 Do These Recent Warning Letters Signal A Shift In FDA Enforcement?
 
Upload an image of your current/old CO2 incubator for a chance to win a brand new FREE NuAire In-Vitrocell NU-5810 CO2 Incubator. Other prizes include a monthly drawing for a branded Under Armour backpack, Camelbak metal water bottle, and various gift cards. All entries will receive a FREE NU-1582 CO2 Incubator Castered Platform with your next NuAire CO2 Incubator purchase. Contest valid until 7/31/2021. Restrictions apply.
Featured Editorial
By Barbara Unger, Unger Consulting Inc.
The FDA posted two unique warning letters that all pharmaceutical and API firms, regardless of their product category, should consider and evaluate. These first-of-a-kind warning letters represent a renewed emphasis on both alternatives to on-site inspections and the importance of purchasing controls and supplier management. ....

Dominic Hyde , Stephen Natoli , Mark Robbins , Oliver Stauffer , Matthew Gorton , Hemi Sagi , Steve Wang , Zoltan Gulyas , Joshua Hicks , Sharon Nowak , Maaike Everts , John Simpson , Brian Stephens , Piergiuseppe Nestola , Bora Pharmaceuticals , White Paper Alconox Inc , Pfeiffer Vacuum Inc , Natoli Engineering Company Inc , Automated Systems Of Tacoma Inc , Pharma Services , Evonik Corporation , Automated Systems , Pfeiffer Vacuum , Thermo Fisher Scientific , Natoli Engineering Company , Sartorius Stedim ,

01.26.21 -- Top 10 Most-Cited MHRA GMP Inspection Deficiencies


01.26.21 Top 10 Most-Cited MHRA GMP Inspection Deficiencies
 
Continuing our Cell & Gene series,
Business of Biotech features Dr. Bobby Gaspar, Orchard Therapeutics CEO, speaking on the challenges his company faces in the production of hematopoietic stem cells to treat neurometabolic disorders, primary immune deficiencies, and blood disorders. Listen now and subscribe so you never miss an episode.
Featured Editorial
By Barbara Unger, Unger Consulting Inc.
In Part 1 of this two-part article, we evaluated the U.K. Medicines and Healthcare products Regulatory Agency’s GMP inspection data for 2019 and addressed the critical and major deficiencies and the annexes and chapters with which they are associated. In this part, we take the 10 chapters and annexes with the highest numbers of deficiencies and do a deeper dive into the specifics of each. ....

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01.07.21 -- Facility Engineering, Design, And Construction Tips For Up-Start Biotech Companies


01.07.21 Facility Engineering, Design, And Construction Tips For Up-Start Biotech Companies
 
 
This report helps small and emerging biopharma companies make more informed CMO decisions, and helps CMOs optimize operational and marketing strategies to better accommodate this segment. Findings are based on 93 service encounters from 42 respondents involved in outsourced small molecule API projects in the past 18 months. Learn more here.
Featured Editorial
By Herman F. Bozenhardt and Erich H. Bozenhardt
Fledgling biotech companies are financially fragile, and they can ultimately become controlled by demanding fund managers. Those who manage facility engineering, design, and construction for these companies must adjust their thinking and employ some new tactics to document all costs and impacts, reduce schedules, and maintain quality. ....

Kevin Queensen , Samsung Biologics , Ray Ryan , Monicam Commerford , Nick Armstrong , Peter Poechlauer , Gabriela Mikhaiel , David Koechlein , Steve Janz , Derek Pendlebury , Sundeep Sethia , Matthew Jones , Patti Cuevas , Shawn Watson , Matthias Wiehn , Amy Trotch , Catalent Bloomington , Maria Lloris , Bernat Busquet , Robertk Haugen , Julie Stiller , Bryan Braxton , Justin Carbungco , Catalent Biologics , Kieran Coffey , Case Study Seeq Corporation ,