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
Introduction Peptide drug formulation challenges encompass the complex chemical and physical degradation risks that biological drugs may encounter during freeze-drying,
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
ADME Bioanalytical Testing Services: What Drug Developers Need from a CRO
Introduction: ADME bioanalytical testing services are the analytical foundation that tells a drug developer whether a molecule behaves the way
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Selecting the Right CRO for Injectable Drug Development
Introduction: Choosing the right CRO for Injectable Drug Development is one of the most important strategic decisions pharmaceutical and biotechnology
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Case Study: Forced Degradation and Stress Testing to Predict Stability Risks in a Bevacizumab Biosimilar Programme
Introduction: Developing a biosimilar monoclonal antibody involves far more than demonstrating analytical similarity with the reference product. One of the
CDMO Services for Generic Oral Solid Dosage Forms: Tablets, Capsules, and Modified-Release ANDA Programs
Introduction Sponsors of generic drugs can improve their time-to-market and increase the likelihood of regulatory approval by utilizing comprehensive CDMO