Introduction Producing audit-ready Extractables and Leachables (E&L) data depends on a scientifically defensible, cGMP-compliant testing architecture capable of proving that […]
Introduction How to Choose a Peptide CDMO? Sponsoring organizations must perform a comprehensive technical audit that assesses chemical synthesis platforms,
Introduction: For sponsors planning an Abbreviated New Drug Application (ANDA) or Abbreviated New Drug Submission (ANDS), one of the first
How Long Does Generic Drug Development Take at a CDMO? Timeline Expectations Explained Read More »
CDMO Technology Transfer Peptide Technology Transfer: A Sponsor’s Step-by-Step Guide to Moving Programs Between CDMOs By Anusha Sinha • July
Introduction Endosomal Escape in Peptide Oligonucleotide Conjugates (POC) Therapeutics refers to the physical translocation of synthetic nucleic acid-peptide chimeras from
Introduction Container closure elastomers are considered one of the most significant sources of extractables and leachables in pharmaceutical packaging. Their
Introduction: GMP Data Integrity for Extractables and Leachables Testing has become one of the most important compliance requirements in pharmaceutical
Data Integrity and 21 CFR Part 11 in a GMP Extractables and Leachables Lab Read More »
Introduction Synthetic peptide active pharmaceutical ingredients (APIs) present unique regulatory and analytical challenges because conventional International Council for Harmonisation (ICH)
Introduction Nitrosamine Testing for Antibiotics and Beta-Lactam APIs is a specialized analytical mandate focused on the detection, identification, and quantification
Introduction Poly(lactic-co-glycolic acid) characterization provides the essential analytical data required to control degradation rates, optimize drug entrapment, and ensure batch-to-batch
