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American Pharmaceutical News In Review
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March 22, 2022
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  Ensuring Drug Safety through Sterilization of Parenteral Products and Evaluation of Extractables

How do you help ensure that your pharmaceutical product can be released to market as quickly and safely as possible? Some important things you must consider include regulatory expectations, container closure integrity, extractables and leachables, method validation, and sterilization assurance. You can learn directly from our industry experts in Philadelphia on May 11th and 12th. There will be two days full of information and discussion about sterilization and lab testing. Learn more.

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» Industry News
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  FDA Approves First LAG-3-Blocking Antibody Combination for Melanoma Treatment
Bristol Myers Squibb announced that OpdualagTM (nivolumab and relatlimab-rmbw), a new, first-in-... read more »
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  Olympia Pharmacy Recalls Seven Compounded Products Due to Being Out-of-Specification
Olympia Pharmacy is voluntarily recalling 11 specific lots of Trimix Formulas F-9, T-105, SB-4, ... read more »
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  Health Canada Authorizes Use of the Moderna Spikevax (50 mcg) COVID-19 Vaccine in Children 6 to 11
Health Canada authorized the use of the Moderna Spikevax (50 mcg) COVID-19 vaccine in children 6 to ... read more »
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  35 Generic Manufacturers to Produce Low-Cost, Generic Versions of Pfizer's Oral COVID-19 Treatment
The Medicines Patent Pool (MPP) announced that it has signed agreements with 35 companies to ... read more »

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» Infographic
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  Transition to Recombinant rFC for Endotoxin Testing: The Sustainable Choice
Transition to Recombinant rFC for Endotoxin Testing: The Sustainable Choice
Recombinant Horseshoe Crab Factor C (rFC) provides a sustainable, highly effective, and environmentally friendly sustainable means of endotoxin ... read more »
» Featured Articles
USP Microbial Contamination Risk Factors Re-Visited
This review article discusses the microbial contamination risk factors presented in USP General Informational Chapter <1111> Microbiological Examination of ... read more »
Improving Preclinical Drug Safety by Evaluating Cytokine Release Syndrome in Humanized Mice
The human immune system is a powerful, intricate defense system that is effective against a wide range of microorganisms and other invading ... read more »
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» Featured Video
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  On-Demand Webinar: Viral Control in Pharmaceutical Processing
This webinar discusses the essential elements of control, testing, and remediation and it includes a spotlight on the maim viruses of concern. watch »
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  On-Demand Webinar: Disinfectant Efficacy Testing – Coupon/Carrier Method
We aim to provide insight into how the results of a coupon study can be utilized to improve cleaning procedures. watch »

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» Featured Products
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  Luminata Product Development Software
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» Featured Whitepaper
eBook: Key Learnings in Mycoplasma Detection for Biologics Quality Control
It is important for the safety and purity of biological products to assure that cell substrates and unprocessed bulk material used during manufacture are free of mycoplasmas. Additionally, regulatory ... read more »
Whitepaper: QC Executive Q&A - Research and Development of Protein-Based Therapeutics
As a global provider, MilliporeSigma offers a wide range of products and services to biopharma. On the analytical side, we have a growing selection of chromatography and sample preparation products ... read more »

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| Events
EVENT
  SMi’s 22nd Annual Pain Therapeutics Conference
London, UK –  05/04/2022
SMi’s 22nd Pain Therapeutics Conference will cover the leading advances in pain therapeutics, exploring late development clinical trials, novel ...
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EVENT
  SMi’s 6th Annual Highly Potent Active Pharmaceutical Ingredients
London, UK –  05/09/2022
The Global High Potency API/HPAPI Market is projected to reach 37 billion USD by 2027, growing at an ever-increasing CAGR of 8.43%. The expanding ...
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