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January 26, 2022

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Qualifying Small-Volume Parenteral Packaging

In many applications the combination between the pharmaceutical product and the selected container-closure system needs to be evaluated for safety, quality, performance, and protection. One of the aspects in this evaluation is the qualification of small-volume parenteral systems and extractable and leachable studies that need to be performed to support regulatory submissions across the globe. You can learn much more about these topics in a free virtual 2-day symposium presented by industry experts from Nelson Labs on March 30th and 31st. Learn More.

	Industry News

Merck Provides U.S. and Japan Regulatory Update for Gefapixant
Merck announced that the FDA has issued a Complete Response Letter (CRL) regarding the NDA for ... read more »

Pfizer and BioNTech Initiate Study to Evaluate Omicron-Based COVID-19 Vaccine in Adults 18 to 55 Years of Age
Pfizer Inc. and BioNTech SE announced the initiation of a clinical study to evaluate the safety, ... read more »

Ionis Announces Eplontersen Receives Orphan Drug Designation from U.S. FDA
Ionis Pharmaceuticals, a leader in antisense therapeutics, announced that the FDA has granted orphan... read more »

The Bioindustry's Most In-Depth, Global Benchmarking and Analysis Study
Your input is important as we benchmark current global and regional trends affecting the bioindustry... read more »

	Infographic

5 Ways to Optimize Water Monitoring
Download this Infographic Now!
This collection of articles covers a number of key topics in pharmaceutical water analysis. read more »

	Featured Articles

Changing the Methods Used for Inactivation of Microorganisms and Viruses For many years pharmaceutical companies have relied upon chemical methods to inactivate microorganisms and viruses present in their facilities. Over ... read more »

Functional Challenges for Alternative Bacterial Endotoxins Tests Part 4: Beyond Recombinant Reagents Introduction The two compendial tests, <151>, “Pyrogen Test” and <85>, “Bacterial Endotoxins Test” (henceforth “RPT” and “BET” respectively) share a common reason for their... read more »

	Featured Video

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 »

	Featured Products

4Cell® Nutri-T Medium
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	Featured Whitepaper

Whitepaper: How to Develop an Efficient Drug Formulation Process
Developing an efficient drug formulation development process requires expertise. Ascendia Pharmaceuticals, a leading specialty CDMO, has been recognized as a Partner of Choice by many drug companies ... read more »

	Events

SMi’s 3rd Annual AI in Drug Discovery Conference
London, UK – 03/14/2022
Exploring the Impact of Machine Learning and Artificial Intelligence in Drug Development from Discovery to Healthcare SMi Group is proud to ... event details »

Symposium the Higher Order Structures
Gaithersburg, MD, United States – 04/04/2022
Protein higher-order structure (HOS) and dynamics are essential to protein function. For protein-based therapeutic products, HOS is a critical quality... event details »

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