Introduction The GMP Manufacturing of Peptide-Oligonucleotide Conjugates requires a Contract Research Organization (CRO) or Contract Development and Manufacturing Organization (CDMO) […]
GMP Manufacturing of Peptide-Oligonucleotide Conjugates: What to Expect from a CRO Read More »
Introduction Selecting between a Phosphorothioate vs Phosphodiester Backbone for peptide-oligonucleotide conjugate (POC) design involves carefully balancing metabolic stability and bio-distribution
Introduction: Peptide Impurity Profiling by LC-MS is an advanced analytical approach used to detect and characterize structurally related impurities in
Introduction A peptide purity testing report, commonly presented as a Certificate of Analysis (CoA) or analytical datasheet, is a critical
How to Qualify and Audit a CDMO Under FDA GMP and ICH Q10 Requirements Read More »
Introduction When a Complete Response Letter (CRL) is issued for a Generic ANDA under 21 CFR 314.110, the applicant immediately
Introduction: A Nitrosamine Compliance Strategy for Biosimilars is fast becoming a required part of modern pharmaceutical quality and regulatory planning,
Introduction Covalently attaching functional peptide vectors to synthetic nucleic acids can substantially modify the pharmacokinetics and biodistribution of oligonucleotide therapeutics
Pharmacokinetics and Biodistribution of Peptide-Oligonucleotide Conjugate Therapeutics Read More »
Introduction: Forced Degradation Testing for Biosimilars is an important analytical strategy for understanding how a biosimilar drug substance changes when
Introduction The choice between the 505(b)(2) vs ANDA Regulatory Pathway depends largely on whether the proposed drug product is an
505(b)(2) vs ANDA: Which Regulatory Pathway Should Your Generic Drug Use? Read More »
Introduction: Dexamethasone Injection CMC requirements are a critical part of developing and submitting a generic injectable drug product through the
CMC Requirements for Dexamethasone Injection ANDA Read More »
