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May 05, 2022

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Ensuring Quality Through a Robust CAPA Program

A well-functioning CAPA program starts with a well-functioning investigations program. One of the most useful strategies for investigations is to ask questions and avoid assumptions. After investigations uncover a problem, further investigations should help determine any root causes. Determining root causes will lead to a robust CAPA. The root cause(s) will direct how a company will take corrective and preventative action. Ultimately the appropriate correction should prevent the deviation from occurring again.

	Industry News

Amphista Therapeutics to Collaborate with Merck for Discovery and Development of Targeted Protein Degradation Therapeutics
Amphista Therapeutics, a provider of next generation targeted protein degradation (TPD) therapeutics... read more »

RedShift BioAnalytics Announces Launch of Next Generation Apollo for Ultra-Sensitive Biophysical Characterization of Biomolecules
RedShift BioAnalytics announces the launch of Apollo, the company’s latest system using ground-... read more »

Belite Bio Receives FDA Fast Track Designation For LBS-008
Belite Bio, Inc, a San Diego based clinical stage biopharmaceutical drug development company ... read more »

FDA Accepts Supplemental New Drug Application (sNDA) and Grants Priority Review for NUBEQA® in Combination with Docetaxel for Metastatic Hormone-Sensitive Prostate Cancer
Bayer announced that the FDA has accepted a supplemental New Drug Application (sNDA) and granted ... read more »

	QC Corner

QC Corner: Environmental Monitoring as a Component of a Contamination Control Strategy
Watch Now! In this webinar, Mark Hallworth discusses environmental monitoring as a component of a ... 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

Maximizing the Return on Investment of Water Quality Analyzers Water quality monitoring is a cornerstone of pharmaceutical production. Whether used as a raw material or for processing, formulation, reagents, ... read more »

Building Resiliency into Single-Use Systems The integration of single-use (disposable) processing equipment has become well accepted in the last 10-15 years. The growth of biological therapies ... read more »

	Featured Video

On-Demand Webinar: FT-NIR Applied to Bioprocess Monitoring in a cGMP Environment
In this webinar, learn how FT-NIR is applied to Bioprocess Monitoring in a cGMP Environment. watch »

On-Demand Webinar: Back to Basics: Growth Promotion Testing
In this webinar you’ll learn the rules for performing growth promotion testing, why we perform growth promotion testing and best practices. watch »

	Featured Products

BRAND® accu-jet® S Pipette Controller
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Discovery DSC 2500
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	Featured Whitepaper

App Note: Cubis® II Lab Balance in the Context of Therapeutic Antibodies
Antibodies are subject to instability issues due to chemical and physical instabilities. Oxidation, disulfide bond formation, Glycation and Deamidation are the most frequent chemical instabilities ... read more »

	Events

PEGS: The Essential Protein Engineering & Cell Therapy Summit
Boston, MA – 05/02/2022
PEGS Boston, The Essential Protein Engineering and Cell Therapy Summit will be returning to Boston, Massachusetts as an in-person event on May 2-6, ... event details »

Excipient World 2022
Gaylord Palms Resort & Convention Center – Kissimmee, FL – 05/02/2022
Excipient World showcases formulation and delivery system advances, regulatory and compliance initiatives, innovative product applications, ... event details »

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