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September 15, 2023

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Transforming CDMO Partnerships Through a Holistic Understanding of Quality

To identify the key indicators of a quality CDMO partner, Thermo Fisher Scientific convened a focus group of pharma and biotech companies and conducted independent interviews with participants. Multiple variables were determined as essential criteria of CDMO quality performance based on the collective feedback. These indicators provide the foundation for a holistic definition of quality performance based on objective parameters, as well as customer needs and expectations. This whitepaper analyzes each criterion, pinpoint tools and best practices to accelerate progress, strengthen collaboration, and cultivate trust.

	Industry News

First Wave BioPharma Licenses Capeserod from Sanofi
First Wave BioPharma, a clinical-stage biopharmaceutical company specializing in the development of ... read more »

AlveoGene Launches to Develop Unique Inhaled Gene Therapies for Rare Respiratory Disorders
AlveoGene, a company focused on transforming rare respiratory disease outcomes using inhaled gene ... read more »

Takeda Commits Over $30M in Five New Global CSR Partnerships
Takeda announced five new partnerships to its Global Corporate Social Responsibility (CSR) Program, ... read more »

FDA Issues Warning Letters to Firms Marketing Unapproved Eye Products
The FDA issued warning letters to eight companies for manufacturing or marketing unapproved ... read more »

	QC Corner

QC Corner: Automated Data Integrity in Sterility Testing
Pharma 4.0 transformation processes are reaching microbiological QC labs, using automation, robotics... read more »

	Infographic

Data Integrity in Pharmaceutical Quality Control
This infographic gives an overview on important terms and definitions, points of compliance, and ways to achieve quality control and data integrity. read more »

	Featured Articles

		Designing an Environmental Monitoring Solution for GMP Applications With the release of the new EU GMP Annex 1 revision, a review of current practices is required to ensure that the installed monitoring system, chosen ... read more »

		The Value and Benefits of Rapid Mold Detection in the Pharmaceutical Industry In the pharmaceutical industry, maintaining a clean and sterile environment is of utmost importance to ensure product quality, safety, and efficacy. ... read more »

	Featured Video

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 »

On-Demand Webinar: Annex 1 Environmental Monitoring Common Questions and Answers
In this live webinar, hear from Mark Hallworth, GMP Scientific Advisor from Particle Measuring Systems as he addresses Annex 1 Environmental ... watch »

	Featured Products

Lasair Pro
Particle Measuring Systems The Lasair Pro supports a complete contamination control solution including clean area monitoring (... learn more »

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 »

MiniCapt® Remote Microbial Air Sampler
Particle Measuring Systems Ideally suited for aseptic environments as part of a facility monitoring system, the MiniCapt® ... learn more »

	Featured Whitepaper

Whitepaper: Use of Laboratory Balances in the Pharmaceutical Industry
Pharmacopoeias are collections of recognized and binding quality regulations that specify, among other things, test requirements and methods for the analysis of drugs. Both the European Pharmacopoeia... read more »

Article: Addressing Challenges with Clinical In-Use Testing of Biotherapeutics
Lonza Drug Product expert Léa Sorret PhD explores Clinical In-Use Testing of Biotherapeutics in this white paper. Lea shares her expertise and describes the key elements to support superior product ... read more »

	More Products

Cary 630 FTIR Spectrometer Learn More
BIOne 1250 Bioprocess Control Station Learn More
Cipher Dissolution Instrument Control Software Learn More

	Directory Categories

Pharmaceutical Excipients Search More

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Pharmaceutical Manufacturing and Testing Services Search More

	Events

Temperature Control & Logistics North American Summit
Falls Church, VA – 09/19/2023
Join us at the Temperature Control & Logistics North American Summit as we cut through the complexity to identify which approaches will work for you, ... event details »

2023 PDA Pharmaceutical Microbiology Conference
Washington, DC – 10/02/2023
The 2023 PDA Pharmaceutical Microbiology Conference continues the ongoing tradition of addressing the opportunities and challenges, most relevant, to ... event details »

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