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Building a CDMO Quality Management System
In the world of pharmaceuticals, quality is not just a measure of product excellence consistent adherence...
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Best Practices for Successful Method Validation
When method validation is performed incorrectly, companies pay a price in multiple ways. Inaccurate method...
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RFQs for Sourcing APIs: Top 9 Things a Drug Substance Supplier Needs to Know
As a bio/pharma API sourcing partner there are two straightforward questions we hear from clients: When...
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How the Right CDMO Partner Can Ensure Your Antibody Drug Conjugate Project is a Success
Antibody-drug conjugates (ADC) are one of the fastest-growing anticancer drug segments, linking the targeting...
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It’s a Simple Formula: Robust OSD Formulation = Successful Drug Product Fulfillment
Oral solid dose (OSD) drugs are pharmaceutical preparations for oral administration in tablets, capsules,...
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What You Need to Know About Post-Approval Change Pathways
Post-approval changes (PACs) – changes made to the drug substance manufacturing process after receiving...
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