Introduction The FDA Purple Book is an online database that enables biopharmaceutical researchers and regulatory specialists to assess FDA-licensed Section […]
Introduction Qualifying plastic manufacturing equipment under USP and requires a structured, risk-based chemical characterization approach to ensure that organic extractables
USP <665> and <1665>: How to Qualify Plastic Components Used in Drug Manufacturing Read More »
Introduction Evaluating Process Equipment-Related Leachables (PERLs) under 21 CFR 211.65 is an essential compliance requirement for pharmaceutical and biopharmaceutical manufacturers
Introduction: Small molecule API process development CDMO services help drug developers convert a promising synthetic route into a robust, scalable
Small-Molecule API Process Development and Scale-Up Services at a CDMO Read More »
Introduction Biosimilar nonclinical toxicity studies are no longer legally required to include in vivo animal testing following the enactment of
Introduction A situation in which a biosimilar comparative efficacy study is still required typically arises when high molecular complexity, a
Introduction Oligonucleotide Purification Explained focuses on assessing Anion-Exchange Chromatography (AEX) and Ion-Pair Reversed-Phase Chromatography (IP-RP), the two primary chromatographic techniques
Introduction: Peptide-Oligonucleotide Conjugation Optimization is the systematic tuning of chemistry, reaction conditions, monitoring and purification so that a peptide and
Case Study: Improving Conjugation Yield in a Complex Peptide-Oligonucleotide Program Read More »
Introduction The analytical characterization of Interferon Beta-1a Biosimilars involves an extensive evaluation of complex N-glycosylation profiles to establish structural and
Interferon Beta-1a Biosimilars: Glycosylation and Analytical Characterization Challenges Read More »
Introduction Formal Biosimilar Biological Product Development (BPD) Meetings serve as an essential regulatory bridge between sponsors and the United States
