American Pharmaceutical News In Review

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June 14, 2022

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Data Integrity for Microbial Detection

The 7000RMS microbial detection analyzer is ready to use in 21CFR.11 and Annex 11-compliant operations. This white paper considers the basics of 21CFR.11 and Annex 11 as they relate to 7000RMS implementation. It also details how the 7000RMS complies with ALCOA+ data integrity principles. A record-keeping system installed within GMP environments may be validated to meet the requirements of 21CFR.11 and Annex 11-compliant operations. The 7000RMS is designed to meet the needs of such validation.

	Industry News

More Sensitive Non-endotoxin Pyrogen Detection Possible with Lonza’s PyroCell Monocyte Activation Test
Lonza has launched the PyroCell® Monocyte Activation Test - Human Serum System (PyroCell® MAT HS ... read more »

Novavax COVID-19 Vaccine Nuvaxovid™ Provisionally Registered in Australia as a Booster in Individuals Aged 18 and Over
Novavax, Inc. announced that the Australian Therapeutic Goods Administration (TGA) has granted ... read more »

Mallinckrodt Resubmits Terlipressin to the FDA for the Treatment of Hepatorenal Syndrome
Mallinckrodt plc announced the resubmission of the Company's New Drug Application (NDA) to the FDA ... read more »

FDA Accepts Application for Merck’s KEYTRUDA® as Adjuvant Therapy for Stage IB – IIIA Non-Small Cell Lung Cancer Following Complete Surgical Resection
Merck announced the FDA has accepted for review a new supplemental Biologics License Application (... read more »

	Infographic

Infographic: Co-processed Excipients Vs. Individually Blended Excipients
Co-processed Excipients Vs. Individually Blended Excipients
Download this infographic to see the top five reasons why co-processed excipients are inherently better than their individually blended counterparts. read more »

	Featured Articles

Single Pass Tangential Flow Filtration for Process Intensification in Biomanufacturing There is growing interest in the application of Single Pass Tangential Flow Filtration (SPTFF) systems for process intensification in biomanufacturing... read more »

High Throughput In Vitro Screening for Transdermal Drug Delivery Transdermal drug delivery is a pain-free, non-invasive alternative to other parenteral options such as injection and infusion that similarly avoids ... read more »

	Featured Video

On-Demand Webinar: Modeling Inflammatory Immune Cell Recruitment and Response with the Colon Intestine-Chip
Join this webinar to learn how you can use the Colon Intestine-Chip to develop more effective, targeted therapeutic strategies for IBD across an ... watch »

On-Demand Webinar: The Data Quality Journey – Focus on Environmental Monitoring Systems
Live Webinar: The Data Quality Journey – Focus on Environmental Monitoring Systems watch »

	Featured Products

Discovery DSC 2500
read more »

Remote Particle Counter: IsoAir® Pro-Plus
read more »

4Cell® Nutri-T Medium
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	Featured Whitepaper

eBook: Glass Related Recalls in Pharma
Typically, drug recalls fall into two categories: recalls issued for the cracking or breaking of glass vials and recalls issued for the presence of particulates being detected in the drug solution. read more »

eBook: Guidance for Cell and Gene Therapy Manufacturing - Meeting GMP and Regulatory Challenges
As biopharmaceutical manufacturers embrace new technologies, mycoplasma testing continues to present challenges at various stages in the production process for cell therapy products. Risk assessment ... read more »

	Events

Controlled Release Society 2022
Montreal, Canada – 07/11/2022
CRS is the home for experts dedicated to delivery science, including delivery scientists, engineers, clinicians, and technical professionals. CRS ... event details »

Microscopy & Microanalysis 2022
Portland, OR – 07/31/2022
Portland provides an ideal summer backdrop for what promises to be another stellar M&M meeting! The Pacific Northwest region is a vacationer's dream, ... event details »

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