12-Year Exclusivity and the 4-Year Filing Bar: When Can a Biosimilar 351(k) Application Be Submitted?
Introduction Under Section 351(k) of the Public Health Service Act (PHS Act), an abbreviated Biologics License Application (aBLA) for a […]
Nitrosation Assay Procedure (NAP Test): How to Assess the Nitrosation Potential of Amine-Containing APIs
Introduction: The Nitrosation Assay Procedure (NAP Test) is an experimental approach for investigating the nitrosation potential of amine-containing active pharmaceutical
How to Use FDA’s Purple Book to Research Reference Products, Exclusivity and Approved Biosimilars
Introduction The FDA Purple Book is an online database that enables biopharmaceutical researchers and regulatory specialists to assess FDA-licensed Section
USP <665> and <1665>: How to Qualify Plastic Components Used in Drug Manufacturing
Introduction Qualifying plastic manufacturing equipment under USP and requires a structured, risk-based chemical characterization approach to ensure that organic extractables
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Process Equipment-Related Leachables (PERLs): A Risk-Based Assessment Under 21 CFR 211.65
Introduction Evaluating Process Equipment-Related Leachables (PERLs) under 21 CFR 211.65 is an essential compliance requirement for pharmaceutical and biopharmaceutical manufacturers
Small-Molecule API Process Development and Scale-Up Services at a CDMO
Introduction: Small molecule API process development CDMO services help drug developers convert a promising synthetic route into a robust, scalable
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Are Animal Toxicity Studies Still Needed for Biosimilars? Nonclinical Testing After the FDA Modernization Act 2.0
Introduction Biosimilar nonclinical toxicity studies are no longer legally required to include in vivo animal testing following the enactment of
When Are Comparative Efficacy Studies Still Needed? Complex and Poorly Characterized Biologics Explained
Introduction A situation in which a biosimilar comparative efficacy study is still required typically arises when high molecular complexity, a
Oligonucleotide Purification Explained: Anion-Exchange vs Ion-Pair Reversed-Phase Chromatography
Introduction Oligonucleotide Purification Explained focuses on assessing Anion-Exchange Chromatography (AEX) and Ion-Pair Reversed-Phase Chromatography (IP-RP), the two primary chromatographic techniques
Case Study: Improving Conjugation Yield in a Complex Peptide-Oligonucleotide Program
Introduction: Peptide-Oligonucleotide Conjugation Optimization is the systematic tuning of chemistry, reaction conditions, monitoring and purification so that a peptide and
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