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November 28, 2022

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Whitepaper: Global regulators’ FAQs on CMC in IND/BLA filing
Whitepaper: Global regulators’ FAQs on CMC in IND/BLA filing
Mammalian cell cultures used in the manufacturing of therapeutics must be tested to ensure lack of mycoplasmal contamination. Previously, the only test for mycoplasma accepted by regulatory agencies was a culture-based test such as the test detailed in USP <63>. Currently, regulatory agencies globally accept nucleic acid testing methods as an alternative to the 28-day test, following acceptable validation, submission and review. This whitepaper will help readers understand some of the regulatory inquiries related to rapid mycoplasma testing and validation, and provide insight into potential responses.

	Industry News

Sartorius BIA Separations and Exopharm to Develop Integrated Technology for Large-Scale Exosome Production
Sartorius BIA Separations (BIA) and Exopharm Ltd. have signed a Material Transfer Agreement and ... read more »

Fujifilm Invests $188M in New Cell Culture Media Manufacturing Facility
FUJIFILM Corporation announced a $188 million investment to establish a cell culture media ... read more »

Alcon Completes Acquisition of Aerie Pharmaceuticals
Alcon announced that it has completed its acquisition of Aerie Pharmaceuticals, Inc. This ... read more »

FDA Fast Tracks New Drug for Accelerated Return of Bowel Function after GI Surgery
Palisade Bio announced that the FDA granted Fast Track designation to LB1148 for the acceleration of... read more »

	QC Corner

Clean Label Podcast with Ken Seufert
Join Ken Seufert, JRS Pharma Chief Executive Officer, and Mike Auerbach, American Pharmaceutical ... read more »

	Infographic

Advancing Raman Microscopy
Download this Infographic Now!
This infographic reviews the latest Raman microscopy features you should look for when choosing a next generation Raman instrument. read more »

	Featured Articles

		Using Space-Charge Electret Products for Contamination Control Recently, the European Union released a revision to the Good Manufacturing Practices (GMP) Annex 1, which provides the rules for the manufacture of ... read more »

		An Interview with Dr.Arne Kusserow and Robin B.Shore, Merck, KGaA, Darmstadt, Germany As you said, chromatography is ubiquitous: it’s used in many different forms and for answering numerous analytical questions in Research and ... read more »

	Featured Video

On-Demand Webinar: Long-Acting Injectables: Successful Microsphere Development and Scale-Up
This webinar will explore existing LAI’s in the context of release profiles, types of molecules, indications, drug loading limits to-date and ... watch »

On-Demand Webinar: Purification Strategies for Industrial Antibody Manufacturing
In this webinar, James Sulzberger and Andy Lloyd, both product Specialists from Sartorius discuss Purification Strategies for Industrial Antibody ... watch »

	Featured Products

BRAND® accu-jet® S Pipette Controller
BRANDTECH® Scientific Brought to you by BRANDTECH® Scientific, the accu-jet® S pipette controller stands alone as ... learn more »

PROSAT Sterile Pi Microfiber Wipes
Contec, Inc. PROSAT® Sterile™ Pi wipes are designed for the most critical environments to control contamination ... learn more »

LCMS-2050 Single Quad Liquid Chromatograph Mass Spectrometer
Shimadzu Scientific Instruments The LCMS-2050 single quadrupole mass spectrometer combines the user-friendliness of an LC detector ... learn more »

	Featured Whitepaper

Poster: Adoption of ATP Bioluminescence Technology
SQZ Biotechnologies has successfully adopted the established Milliflex® Rapid ATP Bioluminescence based RMM (Rapid Microbiological Method) technology platform from MilliporeSigma to support 3 ... read more »

Are You Prepared for the Complexity of Pediatric Drug Development?
The numerous controls and processes in place to ensure a medication is safe, effective, and manufactured with the utmost efficiency make drug development extremely complicated. The challenges of drug ... read more »

	More Products

AeroTrak+ Remote Airborne Particle Counters Learn More
Growth Direct Microbial Contamination Detection System Learn More
REVO R&D Freeze Dryer Learn More

	Directory Categories

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	Events

Pittcon Conference and Expo
Pennsylvania Convention Center | Philadelphia, Pennsylvania, USA – 03/18/2023
We can't wait to see you in person! Pittcon is a catalyst for the exchange of information, a showcase for the latest advances in laboratory science, ... event details »

2023 PDA Annual Meeting
New Orleans, LA – 04/03/2023
The PDA Annual Meeting is the premier meeting on pharmaceutical/biopharmaceutical manufacturing science and technology. event details »

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