Cross-Border Drug Development: One Testing Lab for Both FDA and Health Canada Submissions
Introduction: Sponsors developing a drug for the North American market almost always end up filing in both the United States […]
Disulfide Bond Mapping Service for Biosimilars: LC-MS Approaches and Regulatory Compliance
Introduction Establishing structural equivalence through a specialized Disulfide Bond Mapping Service for Biosimilars is critical for verifying higher-order structural integrity,
Peptide API Scale-Up: From Milligram Discovery Batches to Kilogram GMP Production
Introduction Peptide API Scale-Up requires translating laboratory solid-phase synthesis into scalable, robust, and compliant current Good Manufacturing Practice (cGMP) processes
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Immunogenicity of Peptide-Oligonucleotide Conjugates: Risk Factors, Assessment, and Mitigation Strategies
Introduction The immunogenicity of peptide-oligonucleotide conjugates is a multifaceted biological phenomenon resulting from the synergistic interplay of immunogenic peptide epitopes,
Elemental Impurities (ICH Q3D) and Residual Solvents (ICH Q3C) Testing for Synthetic Peptide APIs
Introduction: Elemental Impurities and Residual Solvents Testing for Synthetic Peptide APIs has become one of the more scrutinized areas of
Peptide Drug Formulation Challenges: Lyophilization, Prefilled Syringes, and Injectable Stability
Peptide Formulation & Stability Peptide Drug Formulation Challenges: Lyophilization, Prefilled Syringes, and Injectable Stability By Anusha Sinha • July 20,
GLP-1 Peptide Manufacturing: Why Semaglutide and Tirzepatide Are Straining Global CDMO Capacity
Introduction Global contract development and manufacturing organization (CDMO) capacity is under severe pressure because the unprecedented multi-ton demand for semaglutide
Solid-Phase vs Liquid-Phase vs Hybrid Peptide Synthesis: Choosing the Right Technology for GMP Manufacturing
Introduction Developing therapeutic peptides within a regulated environment requires selecting a synthetic strategy that effectively balances chemical scalability with stringent
Case Study: PLA Nanoparticle Formulation for Targeted Solid Tumour Oncology Delivery
Introduction: PLA nanoparticle formulation for targeted oncology delivery is one of the more demanding areas of parenteral drug development, because
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Case Study: Nitrosamine Root Cause Investigation and Control Strategy for a Sartan-Class API Manufacturing Site
Introduction: Nitrosamine Root Cause Investigation for Sartan APIs has become a defining requirement across pharmaceutical manufacturing following the global recalls