What Is a Comparative Dissolution Study and When Is It Required for Generic Drug ANDA Approval?
Introduction: For any company preparing to file an Abbreviated New Drug Application (ANDA), a Comparative Dissolution Study for ANDA is […]
Case Study: Stabilising a Growth Hormone Protein API Inside PLGA Microspheres for a 1-Month Depot Formulation
Introduction Stabilising a Growth Hormone Protein API within poly(lactic-co-glycolic acid) (PLGA) microspheres requires the control of several degradation mechanisms, including
Case Study: Building a Nitrosamine Testing Program from Scratch for a Generic Drug Portfolio of 15 Products
Introduction Developing a Nitrosamine Testing Program from scratch for a multi-product generic drug portfolio requires a well-organized, cross-functional strategy that
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,