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January 11, 2023

Newsletter Sponsor

Redesigned Product Validation Guides

AdvantaPure® announces the availability of new validation guides that provide supporting documentation in a comprehensive and organized format. The guides deliver detailed information covering all manufacturing sites, QMS, and the full range of testing on each product based on industry guidance and user feedback. Product validation guides are now available for AdvantaFlex® weldable and sealable tubing and for AdvantaSil® silicone tubing and reinforced hose.

	Industry News

Ajinomoto and Exelixis Enter into a License Agreement to Discover and Develop Novel Antibody-Drug Conjugates for the Treatment of Cancer
Ajinomoto Co., Inc. announced a license agreement with Exelixis, Inc. to incorporate AJICAP®, ... read more »

Spectrum Labs Issues Voluntary Worldwide Recall of Epinephrine USP Bulk API Due to Discoloration of Product
Spectrum Laboratory Products, Inc. is voluntarily recalling three lots of Epinephrine (L-Adrenaline)... read more »

AstraZeneca to Acquire CinCor Pharma
AstraZeneca has entered into a definitive agreement to acquire CinCor Pharma, Inc. (CinCor), a US-... read more »

Santhera and ReveraGen Announce FDA Acceptance of NDA for Vamorolone in Duchenne Muscular Dystrophy
Santhera Pharmaceuticals and ReveraGen BioPharma, Inc. announced that the FDA accepted the new drug ... read more »

	QC Corner

Effective Contamination Control Strategy and Microbial ID Workshop
What is an effective contamination control strategy, microbial ID methodology? This video goes in-... read more »

	Infographic

Guide to Pharmaceutical Support and Services
Download this Infographic Now!
This infographic shows five important categories in which a contract testing services provider should offer a range of tests and deep expertise. read more »

	Featured Articles

		Is COVID-19 mRNA Vaccination Safe in HIV-1 and Other Retroviral Infections? Translocation from the cytoplasm to nucleus and integration of reverse-transcribed SARS-CoV-2 spike mRNA into the genomic DNA of COVID-19 mRNA-... read more »

		FDA’s Updated Inspectional Approach in the Post-Pandemic Landscape The COVID-19 pandemic posed unprecedented challenges to the U.S. Food and Drug Administration’s (FDA) inspection program. Emergency public health ... read more »

	Featured Video

On-Demand Webinar: Real-Time Measurements for Microbial Health of your Pharmaceutical Water System
In this webinar, hear from Peggy Banarhall & Tracy Radcliffe as they discuss Real-Time Measurements for Microbial Health of your Pharmaceutical Water ... watch »

On-Demand Webinar: Organizational Readiness for an FDA Audit of a 503B Compounding Pharmacy
In this webinar, hear from Lisa McChesney-Harris, PhD, CEO, CSO & Founder, as she discusses Organizational Readiness for an FDA Audit of a 503B ... watch »

	Featured Products

StabiCaps
Rousselot BV StabiCaps is a line of gelatins specifically designed for the production of soft gels. StabiCap ... learn more »

Labrafil® M 1944 CS
Gattefossé Oleoyl polyoxyl-6 glycerides NF / Oleoyl macrogol-6 glycerides EP learn more »

Precirol® ATO 5
Gattefossé Glyceryl distearate NF / Glyceryl palmitostearate learn more »

	Featured Whitepaper

Application Note: Pharmaceutical Cleanroom Design Basics
To satisfy the assurances required by regulatory agencies, pharmaceutical products are manufactured in a controlled environment. Cleanrooms are an example of a controlled environment and are employed ... read more »

Whitepaper: Stay on Target: Improving Process Control through Strategic Cascade Feedback Loop Tuning
Well-developed control strategies are essential for reliable and consistent upstream bioprocess manufacturing. Feedback control loops must be properly engineered to ensure critical process parameters ... read more »

	More Products

ALPHA FTIR Routine Spectrometer Learn More
VeriPac 455 Vacuum Decay Technology Inspection System Learn More
Venticell Ovens Learn More

	Directory Categories

Analytical Instrumentation Search More

Pharmaceutical Microbiology Search More

Pharmaceutical Excipients Search More

	Events

IFPAC 2023
North Bethesda, Maryland – 06/04/2023
The IFPAC-2023 meeting is being held June 4-7, 2023. The meeting will remain fully in-person at the Bethesda North Marriot, in North Bethesda, ... event details »

2023 PDA Annual Meeting
New Orleans, LA – 04/03/2023
The PDA Annual Meeting is the premier meeting on pharmaceutical/biopharmaceutical manufacturing science and technology. event details »

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