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June 01, 2022

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Transition from R&D Cell Line Development to GMP Bank Manufacture

Join Eurofins BioPharma Product Testing and Eurofins Discovery for this live webinar focusing on mammalian cell line development and GMP banking requirements to transition your research from an R&D environment to the GMP regulated manufacturing world to take your molecule into the clinic. Topics discussed will include considerations for CHO and HEK-293/Sf9, cell line selection and clonality, GMP documentation and additional testing. Register today!

	Industry News

FDA Approves Label Extension for Evrysdi® for Infants with Spinal Muscular Atrophy Under 2 Months Old
PTC Therapeutics, Inc. announced that the FDA has approved a label extension for Evrysdi® (risdiplam... read more »

FDA Accepts NDA Filed by Avillion for AstraZeneca's Asthma Treatment
Avillion LLP, a drug development company focused on the co-development and financing of ... read more »

Regeneron Completes Acquisition of Checkmate Pharmaceuticals
Regeneron Pharmaceuticals, Inc. announced that it has successfully acquired Checkmate ... read more »

FDA Approves Two Opdivo® Regimens as First-Line Treatments for Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has approved both ... read more »

	QC Corner

Robotics and Automation: The Future of Pharma QC
Watch Now! The pharmaceutical industry is evolving towards automated, intensified and real-time-... read more »

	Infographic

Infographic: Co-processed Excipients Vs. Individually Blended Excipients
Co-processed Excipients Vs. Individually Blended Excipients
Download this infographic to see the top five reasons why co-processed excipients are inherently better than their individually blended counterparts. read more »

	Featured Articles

Use of Statistical Models to Uncover Fraud, Shorten Timelines and Improve Patient Safety Unsupervised statistical monitoring could have uncovered fraud at a clinical trial site around a year earlier than traditional methods were able to do... read more »

Microbial Control During Process Pool Holds of Biological Products – Building Quality into the Production Process Production processes for biological products are often designed to include in-process hold steps to provide flexibility during operations. During hold... read more »

	Featured Video

On-Demand Webinar: Modeling Inflammatory Immune Cell Recruitment and Response with the Colon Intestine-Chip
Join this webinar to learn how you can use the Colon Intestine-Chip to develop more effective, targeted therapeutic strategies for IBD across an ... watch »

On-Demand Webinar: The Data Quality Journey – Focus on Environmental Monitoring Systems
Live Webinar: The Data Quality Journey – Focus on Environmental Monitoring Systems watch »

	Featured Products

Discovery DSC 2500
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Nano DSC Complete Autosampler System v2
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Luminata Product Development Software
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	Featured Whitepaper

eBook: Guidance for Cell and Gene Therapy Manufacturing - Meeting GMP and Regulatory Challenges
As biopharmaceutical manufacturers embrace new technologies, mycoplasma testing continues to present challenges at various stages in the production process for cell therapy products. Risk assessment ... read more »

eBook: Glass Related Recalls in Pharma
Typically, drug recalls fall into two categories: recalls issued for the cracking or breaking of glass vials and recalls issued for the presence of particulates being detected in the drug solution. read more »

	Events

ASMS Conference
Minneapolis, Minnesota – 06/05/2022
The 70th ASMS Conference on Mass Spectrometry and Allied Topics (ASMS 2022) will take place 5-9 June 2022 in Minneapolis, MN, USA. The annual ... event details »

Controlled Release Society 2022
Montreal, Canada – 07/11/2022
CRS is the home for experts dedicated to delivery science, including delivery scientists, engineers, clinicians, and technical professionals. CRS ... event details »

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