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August 16, 2023

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Webinar: Microbial Identification and Control - Meeting Regulatory Requirements

Microbial control within biopharmaceutical manufacturing is a critical quality control to help ensure drug products are free from viable microorganisms. Per regulatory guidelines, the implementation of an environmental monitoring program is required to comply with current good manufacturing practices (cGMP) and identification of microorganisms to species level is a minimal requirement. Join us for a discussion on implementing an environmental program, including regulatory expectations.

	Industry News

Roquette Acquires Qualicaps
Roquette announced an agreement to acquire Qualicaps and reinforce its position as a major supplier ... read more »

FDA Accepts Three IND Transfers from Biostax Corp. for the Treatment of NASH, NAFLD and AIH
Immune Therapeutics, Inc. d/b/a Biostax Corp. announced that they have accepted the transfer of ... read more »

Sandoz Announces Positive Results From Mylight Phase lll Study for Biosimilar Aflibercept
Sandoz released positive results from the MYLIGHT Phase III confirmatory efficacy and safety study ... read more »

Novartis Acquires Chinook Therapeutics
Novartis announced that it has completed its acquisition of Chinook Therapeutics, a Seattle, WA, ... read more »

	QC Corner

On-Demand Webinar: Ensure your Pipetting is QC Compliant
In this webinar, Joni Åke, Product Manager at Sartorius, and Axel Taube, Service Product Manager at ... read more »

	Infographic

Extractables and Leachables Testing for (Bio)Pharmaceuticals
This infographic breaks down some of the most important terms and definitions of the E&L process. Download this infographic to learn more. read more »

	Featured Articles

		Transitions Have you heard the term: liminal space? I first learned of the term while watching the excellent AppleTV series Severance. Without giving too much... read more »

		Origin and Application of the 50-200% Range in the Bacterial Endotoxins Test Laboratory analysts who have been performing compendial Bacterial Endotoxins testing (BET) for a number of years have come to accept the idea that the... read more »

	Featured Video

On-Demand Webinar: Microbial Identification and Control - Meeting Regulatory Requirements
Microbial control within biopharmaceutical manufacturing is a critical quality control to help ensure drug products are free from viable ... watch »

On-Demand Webinar: Container Closure Requirements: Preparing for USP 382, 661.1, and 661.2
Container closures are critical to ensure sterility of drug products. Physical, chemical, and biological assessments must be made to ensure components... watch »

	Featured Products

BRAND® HandyStep® Touch Electronic Repeating Pipette
BRANDTECH® Scientific The BRAND® HandyStep® Touch and Touch S are the first electronic repeating pipettes with touchscreen... learn more »

Klucel™ exf ultra hpc
Ashland Inc. Klucel™ EXF Ultra HPC, ultra fine particle size, takes tablet binding effectiveness to the next ... 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

eBook: Formulation of Dry Powder Inhaler
Learn about the local treatment of non-small cell lung cancer with a spray-dried bevacizumab Formulation and simultaneous spray drying for innovative dry-powder inhaler combination formulations in ... read more »

Whitepaper: Microbial Testing for the Pharmaceutical Industry
This white paper covers what you should consider when implementing a microbial identification system, including ensuring data integrity and validating the computer system used for microbial testing in... read more »

	More Products

1290 Infinity II Diode Array Detector Learn More
8700 LDIR Chemical Imaging System Learn More
Clarity LC BioSolutions for Synthetic DNA/RNA Learn More

	Directory Categories

Bioprocessing Search More

Drug Delivery Search More

Pharmaceutical Excipients Search More

	Events

Global Bioprocessing Summit
Berlin, Germany – 11/16/2023
The industry, professionals, and scientists are actively seeking methods to delineate more precise guidelines and anticipated requirements for ... event details »

AAPS PharmSci 360
Orlando, FL – 10/22/2023
PharmSci 360 delivers research from across the pharmaceutical continuum, from discovery to delivery, and all stages in between. Thousands of ... event details »

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