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Sterility Assays in Drug/Device Manufacturing

In the biomanufacturing industry, Critical Quality Attributes (CQA) are essential standards that must be met before biopharmaceuticals or medical devices can be released for patient use. As a fundamental component of CQA for a Drug Product (DP), manufacturers are required to conduct rigorous testing to ensure compliance with regulatory limits for adventitious agents.


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Mol2Med™ Integrated Services Developability Assessment API Form and Solid-State Research Crystallization Development Services Pre-formulation Studies Formulation and Analytical Development GMP Manufacturing Clinical Supply
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Small Molecule
Mol2Med™ Integrated Services Developability Assessment API Form and Solid-State Research Crystallization Development Services Pre-formulation Studies Formulation and Analytical Development GMP Manufacturing Clinical Supply
Crystal Bio Solutions
Biologics CMC Analytical Services Bioanalytical and Biomarker Services Quantitative Clinical Pharmacology (QCP)
Technology
Quick Links
About Us Events
NJ Sites: Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey, USA 08512
2005 Eastpark Blvd, Cranbury, New Jersey, USA 08512
CA Site: 7133 Koll Center Parkway, Suite 200, Pleasanton, California, USA 94566
bd_global@crystalpharmatech.com +1-609-604-8303
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