Introduction Evaluating immunogenicity without a comparative efficacy trial relies on replacing Phase III clinical efficacy studies with orthogonal bioanalytical characterization, […]
Introduction The chemical synthesis of glycoproteins enables the precise, cell-free assembly of full-length, functional proteins containing uniform oligosaccharide chains. This
Chemical Synthesis of Glycoproteins: How Interferon β-1a Was Made Without Living Cells Read More »
Introduction The implementation of ICH Q7 for Peptide APIs establishes the essential regulatory framework and Good Manufacturing Practice (GMP) requirements
ICH Q7 for Peptide APIs: What GMP Really Means at Each Step of Peptide Synthesis Read More »
Introduction: Deriving an NDSRI Acceptable Intake Limit for a novel nitrosamine drug substance-related impurity with no existing toxicology data is
Introduction: A “reasonably expected” nitrosamine is one that your chemistry, process, materials or storage make plausible, and that judgment decides
Introduction Justifying Regulatory Starting Materials for Synthetic Peptides under the International Council for Harmonisation (ICH) Q11 guideline requires a robust
Regulatory Starting Materials for Synthetic Peptides: How to Justify Them Under ICH Q11 Read More »
Introduction Establishing rigorous quality attributes for Amino Acid Derivatives and Building Blocks is one of the most critical factors in
Introduction Neutralizing Antibody (NAb) Assays for Biosimilars evaluate the functional ability of anti-drug antibodies (ADAs) to inhibit the mechanism of
Introduction: PCL Subcutaneous Implant Development is an emerging approach for designing long-acting hormonal drug delivery systems that may release an
Case Study: PCL Subcutaneous Implant Development for 12-Month Hormonal Drug Delivery Read More »
Introduction The evolution of therapeutic peptides from research reagents to approved drugs over the past 50 years represents a major
From Research Reagent to Approved Drug: How Therapeutic Peptides Evolved Over 50 Years Read More »
