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
Introduction Quality control of Oligonucleotide Starting Materials involves systematic analytical characterization, impurity quantification, and physical validation of phosphoramidites and functionalized
