USP <1663> and <1664> in Practice: How GMP Labs Apply Them to Extractable & Leachable Studies
Introduction: USP <1663> and <1664> E&L Testing is the analytical backbone that connects a packaging or delivery-system material to a […]
Case Study: NDSRI Identification, Potency Prediction, and Confirmatory Quantification for a Novel NDA Submission
Introduction Executing NDSRI Identification, Potency Prediction, and Confirmatory Quantification represents an important regulatory milestone for obtaining New Drug Application (NDA)
Case Study: Bioanalytical Support for an AAV Gene Therapy IND — Navigating Novel Matrix and Sensitivity Challenges
Introduction Delivering comprehensive Bioanalytical Support for an AAV Gene Therapy IND requires the validation of highly sensitive molecular and immunoassay
What Is a Peptide CDMO? Capabilities, Services, and How They Differ from Small-Molecule CDMOs
Introduction: A Peptide CDMO is a Contract Development and Manufacturing Organization that provides specialized development, analytical, process, and manufacturing services
Case Study: Scaling a GLP-1 Analog from Preclinical Synthesis to GMP Kilogram-Scale Manufacturing
Introduction Scaling a GLP-1 analog from preclinical synthesis to Good Manufacturing Practice (GMP) kilogram-scale manufacturing involves moving beyond small-scale discovery
Single-Use Systems and GMP Extractables and Leachables (E&L) Testing: Managing Leachables Risk in Biologics
Introduction Single-Use Systems and GMP Extractables and Leachables (E&L) Testing establishes the analytical foundation necessary for detecting, identifying, quantifying, and
Designing a GMP-Compliant Extractables and Leachables (E&L) Study for Container Closure Systems
Introduction Designing a GMP-Compliant Extractables and Leachables (E&L) Study requires a structured, risk-based approach that brings together advanced analytical chemistry,
Case Study: Analytical Characterization of a Multi-Linker Peptide-Oligonucleotide Conjugate
Introduction: Analytical characterization of peptide-oligonucleotide conjugates becomes significantly more complex once a molecule moves from a single-linker design to a
Case Study: Supporting a Poorly Soluble Generic API Through Formulation Screening and ANDA-Ready Analytics
Introduction Supporting a poorly soluble generic API requires an integrated Chemistry, Manufacturing, and Controls (CMC) framework that combines systematic reference-listed
Case Study: Generic Metered Dose Inhaler (MDI) ANDA Development — Formulation, Device Characterization, and BE Study Design
Introduction Executing a successful Generic Metered Dose Inhaler (MDI) ANDA Development program requires a comprehensive weight-of-evidence regulatory framework that demonstrates