American Pharmaceutical News In Review

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July 14, 2023

Newsletter Sponsor

Compendial Water Testing and Data Integrity Challenges
Sponsored by Veolia Water Technologies & Solutions
TOC data & data integrity are critical components to successful and compliant cGMP processes. Currently, many facilities fail to apply the same validation standards & protocols to software as instruments. The software where data is managed & stored should have the same comprehensive validation standards! Like instruments, software has a set of specifications that describe functions & compliance with regulations, for ex: 21 CFR Part 11. Software validation is fundamental to risk management & mitigation when it comes to data integrity.

	Industry News

SERB Pharmaceuticals Acquires Vistogard® and Xuriden® from Wellstat Therapeutics
SERB Pharmaceuticals acquired two medicines, Vistogard® (uridine triacetate) and Xuriden® (uridine ... read more »

Aeterna Zentaris Outlines Progress on Development Pipeline Programs and Provides Corporate Update
Aeterna Zentaris provided a lengthy update on its therapeutic and diagnostic development pipeline ... read more »

FDA Approves First OTC Daily Oral Contraceptive
The FDA has approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy. This ... read more »

Longeveron Names Chief Medical Officer for Cellular Therapy Programs
Longeveron announced the appointment of Nataliya Agafonova, M. D., as the Company’s Chief Medical ... read more »

	QC Corner

Oxygen Transfer Considerations for Expanding Cell and Gene Therapy Cultures in Stirred-Tank Bioreactors
Mike Auerbach, Editor in Chief of American Pharmaceutical Review magazine, speaks with Justin Cesmat... read more »

	Infographic

Extractables and Leachables Testing for (Bio)Pharmaceuticals
This infographic breaks down some of the most important terms and definitions of the E&L process. Download this infographic to learn more. read more »

	Featured Video

Watch Video: New Age Industries® Single Use Systems for Biologics and Pharmaceuticals
In this video, hear from Ken Baker, CEO of New Age Industries® as he talks about Single Use Systems for Biologics and Pharmaceuticals. watch »

Watch Video - viewLinc Continuous Monitoring System
In this video, hear from Paul Daniel, Senior GxP Regulatory Export from Vaisala as he discusses the viewLinc Continuous Monitoring System. watch »

	Featured Products

Thermo Scientific™ Pharma 11 Twin-screw Extruder
Thermo Fisher Scientific Perform material- and labor-effective extrusion and granulation processes with the Pharma 11 Twin-... learn more »

LCMS-2050 Single Quad Liquid Chromatograph Mass Spectrometer
Shimadzu Scientific Instruments The LCMS-2050 single quadrupole mass spectrometer combines the user-friendliness of an LC detector ... learn more »

SALD-2300 Laser Diffraction Particle Size Analyzer
Shimadzu Scientific Instruments Ensuring outstanding product quality in a variety of industries, Shimadzu’s SALD-2300 is able to ... learn more »

	Featured Whitepaper

eBook: Enhancing Impurity Control with Data Management
Pharmaceutical development teams must demonstrate a comprehensive understanding of impurities found in their medication. This requires high-quality data, but handling the necessary information is a ... read more »

Upstream Process Development with a kLa Criterion Within the BIOne Single-Use Bioreactor
The findings of this study affirm the effectiveness of utilizing kLa as a central criterion for bioprocess development. Moreover, these results highlight the remarkable suitability of the BIOne SUB ... read more »

	More Products

Abbemat 200 Economy Line Refractometer Learn More
AccuPyc II HP 1340 High Pressure Pycnometer Learn More
DOMINA Tablet Press Learn More

	Directory Categories

Pharmaceutical Inspection Search More

Mycoplasma Detection and Testing Search More

Pharmaceutical Excipients Search More

	Events

SciX 2023
Sparks, NV – 10/08/2023
SciX 2023 will be in Sparks, Nevada October 8-13, 2023 – our 50th Annual Meeting! This leading conference presented by FACSS has world-class technical... event details »

15th Annual Next Generation Dx Summit
Washington, D.C. – 08/21/2023
CHI's 15th Annual Next Generation Dx Summit will take place in-person at the Grand Hyatt Washington, D.C. on August 21-23, 2023. The Next Generation ... event details »

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