How Molecular Weight and End-Group Chemistry of PLGA Affect Degradation Rate and Drug Release
Introduction: PLGA Molecular Weight and End-Group Chemistry together determine how quickly a PLGA matrix hydrolyzes and how a drug moves […]
ICH Q2(R2) and ICH Q14: How CDMOs Apply the Analytical Procedure Lifecycle
Introduction Contract Development and Manufacturing Organizations (CDMOs) implement ICH Q2(R2) and ICH Q14 as an integrated, lifecycle-oriented framework that brings
ICH Q2(R2) and ICH Q14: How CDMOs Apply the Analytical Procedure Lifecycle Read More »
CDMO Quality Agreements: What FDA Guidance Requires and What Sponsors Should Include
Introduction CDMO Quality Agreements function as legally binding quality management frameworks established under Current Good Manufacturing Practice (CGMP) regulations to
CDMO Quality Agreements: What FDA Guidance Requires and What Sponsors Should Include Read More »
Analytical Method Transfer Between CDMO Sites: Protocols, Acceptance Criteria, and USP <1224>
Introduction Analytical Method Transfer Between CDMO Sites is a formal and documented process used to qualify a receiving Contract Development
How Do You Detect and Quantify D-Amino Acid Impurities in a Synthetic Therapeutic Peptide?
Introduction: D-Amino Acid Impurity Analysis in Peptides is the set of analytical procedures used to detect, locate, and quantify unwanted
Phase-Appropriate CMC Development at a CDMO: What Changes from Preclinical to Phase III
Introduction Phase-Appropriate CMC Development at a CDMO represents a risk-managed approach to scaling that aligns Chemistry, Manufacturing, and Controls activities
Phase-Appropriate CMC Development at a CDMO: What Changes from Preclinical to Phase III Read More »
Analytical Characterization for 505(b)(2) Peptide Products: Comparative Data to Bridge to the Listed Drug
Introduction Analytical Characterization for 505(b)(2) Peptide Products provides the comprehensive physicochemical, structural, and functional profile required to establish product safety,
Peptide-Drug Conjugate (PDC) Characterization Services: Conjugation Site, Payload Ratio and Linker Stability
Introduction Peptide-Drug Conjugate (PDC) Characterization Services deliver specialized analytical testing that uses high-resolution mass spectrometry and liquid chromatography to confirm
Case Study: PLA Nanoparticle Formulation for Targeted Solid Tumour Oncology Delivery
Introduction: PLA nanoparticles for targeted cancer delivery are nanoscale polymeric carriers in which an anticancer compound is incorporated into biodegradable
Case Study: PLA Nanoparticle Formulation for Targeted Solid Tumour Oncology Delivery Read More »
GMP Release and ICH Stability Testing Services for Peptide Drug Substance and Drug Product
Introduction The execution of GMP Release and ICH Stability Testing establishes the comprehensive analytical framework necessary to demonstrate that therapeutic