Introduction: The FDA Regulatory Pathway for Peptide-Oligonucleotide Conjugates is not determined simply by identifying a product as either a peptide […]
What FDA Regulatory Pathway Applies to Peptide-Oligonucleotide Conjugate Therapeutics? Read More »
Introduction: For any company preparing to file an Abbreviated New Drug Application (ANDA), a Comparative Dissolution Study for ANDA is
Introduction Stabilising a Growth Hormone Protein API within poly(lactic-co-glycolic acid) (PLGA) microspheres requires the control of several degradation mechanisms, including
Introduction Developing a Nitrosamine Testing Program from scratch for a multi-product generic drug portfolio requires a well-organized, cross-functional strategy that
Introduction: USP <1663> and <1664> E&L Testing is the analytical backbone that connects a packaging or delivery-system material to a
Introduction Executing NDSRI Identification, Potency Prediction, and Confirmatory Quantification represents an important regulatory milestone for obtaining New Drug Application (NDA)
Introduction Delivering comprehensive Bioanalytical Support for an AAV Gene Therapy IND requires the validation of highly sensitive molecular and immunoassay
Introduction: A Peptide CDMO is a Contract Development and Manufacturing Organization that provides specialized development, analytical, process, and manufacturing services
Introduction Scaling a GLP-1 analog from preclinical synthesis to Good Manufacturing Practice (GMP) kilogram-scale manufacturing involves moving beyond small-scale discovery
Introduction Single-Use Systems and GMP Extractables and Leachables (E&L) Testing establishes the analytical foundation necessary for detecting, identifying, quantifying, and
