American Pharmaceutical News In Review

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September 20, 2021

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An advancement in contamination monitoring solutions. The new PRO Series of complete contamination control solutions helps you provide lifesaving and life changing solutions to your customers by confirming clean manufacturing. The PRO Series includes portable and remote, viable and non-viable particle counters and FMS and Data Management solutions. Select any products or services from the PRO Series with the confidence that they are fully compliant with the most recent global regulations and are positioned for anticipated regulatory requirements.

	Industry News

FDA Authorizes Antibody Therapy for Post-Exposure Prophylaxis for COVID-19
The FDA revised the emergency use authorization (EUA) for bamlanivimab and etesevimab, administered ... read more »

Jacobus Pharmaceutical Company Inc. Issues Voluntary Worldwide Recall of Ruzurgi 10 mg Tablets Due to Yeast, Mold and Bacterial Contamination
Jacobus Pharmaceutical Company Inc. is voluntarily recalling 3 lots of Ruzurgi® (amifampridine) 10 ... read more »

Zai Lab Expands U.S. Operations to Join the Cambridge Biotechnology Community
Zai Lab Limited an innovative commercial-stage biopharmaceutical company, announced that it will ... read more »

FDA and Press Updates on Chantix Recall
FDA is alerting patients and health care professionals that Pfizer is expanding its voluntary recall... read more »

	Infographic

5 Key Steps to a Successful Laboratory Relocation
20 instruments or 2,000? Across the hall or across the world? Moving a laboratory anywhere can be an extensive process. Worried you'll overlook an ... read more »

	Featured Articles

Microbiology of COVID-19: The Rise of the Mutants, Emergence of SARS-CoV-2 Variants as a Response to Evolutionary Pressures to Optimize Viral Transmissibility and Replication The COVID-19 pandemic has presented major challenges to national public health systems and created serious socio-economics disruptions around the ... read more »

Quantification of Residual Host Cell DNA in Protamine Sulfate Drug Product Using Droplet Digital PCR Protamine Sulfate (ProS) is the only FDA approved anticoagulation reversal agent for unfractionated heparin. ProS is biologically derived from chum ... read more »

	Featured Video

On-Demand Webinar: Development and Validation of a Platform Assay Method Using Variable Pathlength Technology for Oligonucleotide Drug Products
This webinar will share Ionis’ experience with developing and validating a platform SoloVPE® in-process assay method for GMP manufacturing of ... watch »

On-Demand Webinar: Clarifying Pharmacopeial Requirements for Pharma Waters and Process Analytics
In this webinar you’ll learn answers to common questions to distinguish actual pharmacopeial requirements for pharmaceutical waters vs what has become... watch »

	Featured Products

Sterile CyQuanol Disinfectant Solution
read more »

	Featured Whitepaper

eBook: The Modern Microbiologist’s No-Nonsense Guide to Quality Control
The growth promotion test (GPT) can be a hassle, but it’s necessary for determining if a new batch of media is acceptable. Pharmaceutical Microbiologists have the great responsibility of ensuring ... read more »

	Events

SMi’s Aseptic Processing Conference
London, UK – 09/20/2021
The aseptic processing industry has seen many changes during its progression towards the 21st century. With advances in innovative therapeutic ... event details »

Oligonucleotide Therapeutics and Delivery Conference
London, UK – 09/22/2021
On the way to maximising the potential of oligo-based medicine Oligonucleotide therapeutics - the emerging medicine class - are harnessing the ... event details »

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