American Pharmaceutical News In Review

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November 02, 2021

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Learn from industry peers about their validation strategy for a fluorescence-based rapid detection method

Innovative rapid technologies have numerous advantages over traditional culture-based methods, particularly their faster time to result. Discover how a renowned microbiology QC expert used Milliflex® Quantum to significantly reduce the time needed to detect and count colony forming units (CFUs). The article describes the validation strategy for the rapid detection system to detect microorganisms in pharmaceutical grade water.

	Industry News

Merck Recalls CUBICIN® injection Due to Presence of Glass Particles
Merck is voluntarily recalling one lot of CUBICIN® (daptomycin for injection) 500 mg for intravenous... read more »

Bristol Myers Squibb Receives European Commission Approval for Opdivo + Chemotherapy for Patients with Gastric, Gastroesophageal Junction or Esophageal Adenocarcinoma
Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved ... read more »

Canada Announces Accelerated Delivery of COVID-19 Pediatric Vaccine
Throughout the pandemic, the Government of Canada has worked closely with vaccine manufacturers to ... read more »

FDA Update on Review of Biologics License Application (BLA) for Bimekizumab
UCB, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration ... read more »

	Infographic

Scaling-Up to Preparative HPLC: Advice for a Successful Scale-Up Process
Preparative HPLC is more focused than traditional HPLC and must therefore offer different capabilities than a normal analysis system. read more »

	Featured Articles

How Can Mathematical Modelling Support the Development of Next Generation Bioprocesses? The adoption of high-throughput experimentation systems and advances in multi-omics analysis methods are generating large volumes of bioprocessing ... read more »

Clarifying and Meeting the Requirements of 21 CFR Part 11 and Data Integrity for Dissolution Testing Since the release of the latest FDA guidance documents on 21 CFR part 11 and data integrity, there has been much confusion regarding what is required ... read more »

	Featured Video

On-Demand Webinar: Unified Particle Analysis by Raman and Infrared Microscopy
In this webinar you’ll learn: Identification of unknown particles in a wide variety of manufacturing processes. Reverse engineering and failure ... watch »

	Featured Products

Sievers M9 TOC Analyzers
read more »

	Featured Whitepaper

Scientific Poster: “Error-proofing” and “Future-proofing”: Updating the Bacterial Endotoxins Test with Automation and Recombinant Reagents – Part Deux
The use of robotics and automation reduces error levels common to many manual processes, thus saving time and resources spent on such tasks. Studies comparing manual and automated pipetting and mixing... read more »

	Events

Ophthalmic Drugs Conference
London, UK – 11/22/2021
The global ophthalmic drug market is forecast to surpass $60 billion USD by 2025 with increasing focus from the industry on alternative delivery ... event details »

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