Amino Acid Derivatives and Building Blocks: How Raw Material Quality Shapes Impurities in GMP Peptides
Introduction Establishing rigorous quality attributes for Amino Acid Derivatives and Building Blocks is one of the most critical factors in […]
Introduction Establishing rigorous quality attributes for Amino Acid Derivatives and Building Blocks is one of the most critical factors in […]
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 »
Introduction Understanding the peptide characterization timeline is essential for pharmaceutical companies preparing an Investigational New Drug (IND) application or an
How Long Does Peptide Characterization Take for an ANDA or IND Submission? Read More »
Introduction: Synthetic Peptide Impurity Analysis is the process of detecting, characterizing and controlling structurally similar impurities that remain after peptide
Introduction: Peptide Identity and Purity Testing is essential for determining whether a compounded or research-grade peptide is the correct molecule
How Can You Verify the Identity and Purity of Compounded or Research-Grade Peptides? Read More »
Introduction: Immunogenicity Risk Assessment of Peptide Impurities is a key part of pharmaceutical development whenever an unexpected impurity appears in
Case Study: Immunogenicity Risk Assessment of a New Impurity in a Generic Peptide ANDA Read More »
Introduction: Peptide Synthesis vs Protein Manufacturing is an important distinction in pharmaceutical development, biotechnology, and analytical science, and the two
Is Peptide Synthesis the Same as Protein Manufacturing? Read More »
Introduction Peptide Analytical Method Development and Validation is a critical component of peptide drug development because peptide molecules present analytical
Peptide Analytical Method Development and Validation Services under ICH Q2(R2) and Q14 Read More »
Introduction The comprehensive implementation of Oral Peptide Drug Product Characterization requires an integrated assessment of intestinal permeation enhancers, enzymatic degradation
Introduction Characterizing Peptides in PLGA Microsphere and Depot Formulations requires sophisticated orthogonal analytical methodologies to assess complex drug release kinetics,