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May 26, 2021

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Requirements and Impact of the New Guideline – ISO 10993-23: Tests for Irritation-Body

The requirements for assessing irritation is now moved from ISO 10993-10 to ISO 10993-23 and with this new standard comes the inclusion of in vitro irritation testing.

	Industry News

Ajinomoto Bio-Pharma Services Expands Fill Finish Capacity
Ajinomoto Bio-Pharma Services (Aji Bio-Pharma), a leading provider of biopharmaceutical contract ... read more »

FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer
The U.S. FDA approved Rybrevant as the first treatment for adult patients with non-small cell lung ... read more »

Xeris Pharmaceuticals, Inc. to Acquire Strongbridge Biopharma plc in Stock and CVR Transaction
Xeris Pharmaceuticals, Inc., a pharmaceutical company leveraging its novel formulation technology ... read more »

	Featured Announcements

Register Now: Risk Assessment for Drug Products and Medical Devices
Webinar
This webinar will address how to deal with “Risk Assessment for Potential Elemental Impurities” on Drug Products and Medical Devices. The USP, in parallel with the International Council for Harmonization of Technical Requirements for Pharmaceuticals ... read more »

	Infographic

Top 5 Things to Know About the USP <643> Changes
The United States Pharmacopeia (USP) specifies regulations for pharmaceutical manufacturing to ensure safe and effective drug products. USP <643> Total ... read more »

	Featured Articles

Raman Process Modelling and Glucose Control for Biologics Abstract Pharmaceutical manufacturing continues to expand the use of Raman spectroscopy and is especially useful in CHO cell-based processes such ... read more »

Microfluidic Automation and the Sievers Eclipse BET Platform - FAQs Microfluidic automation is the simplest form of automation available to the market today. It simplifies endotoxin testing in a platform that is ... read more »

	Featured Video

On-Demand Webinar: Risk Assessment for Potential Elemental Impurities on Drug Products/Medical Devices
This webinar will address how to deal with “Risk Assessment for Potential Elemental Impurities” on Drug Products and Medical Devices. The USP, in ... watch »

On-Demand Webinar: Increase Overall GMP Operational Efficiencies with Dilution-free Concentration Measurement and Capital ROI within 12 Months
Live Webinar: Increase Overall GMP Operational Efficiencies with Dilution-free Concentration Measurement and Capital ROI within 12 Months watch »

On-Demand Webinar: Scalable In-line Concentration Measurement for Biologic Process Development and GMP Manufacturing
In this webinar you'll learn what is Variable Pathlength Technology and how it differs from traditional UV-Vis techniques and equipment, overview of ... watch »

	Featured Whitepaper

eBook: Slope Spectroscopy Method
The SoloVPE System is an innovative instrument for the UV-VIS-NIR spectroscopy. read more »

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