Introduction Charge Variant Profiling by icIEF identified a critical comparability failure in an adalimumab biosimilar candidate by detecting an unacceptable […]
Introduction Resolving an Out-of-Specification Impurity Result during therapeutic peptide manufacturing requires a systematic analytical and regulatory approach to identify the
Introduction: Injectable steroid manufacturing scale-up is one of the most technically demanding transitions in sterile parenteral drug development, because a
Scale-Up Challenges in Injectable Steroid Manufacturing Read More »
Introduction: Nitrosamine sample preparation and extraction is the single most consequential step in generating defensible, low-level impurity data — get
Introduction: Bioanalytical CRO Services for Gene Therapy provide the specialized analytical support needed to measure therapeutic agents, biomarkers, biological responses,
Bioanalytical CRO Services for Gene Therapy and AAV-Based Drug Programs Read More »
Introduction: Container Closure Systems for Injectable Steroids are a foundational part of injectable drug-product development, since the packaging system must
Container Closure Systems for Injectable Steroids Read More »
Introduction: Extractables and Leachables in Lyophilized Drug Products are important pharmaceutical quality considerations because chemical substances originating from packaging and
Extractables and Leachables in Lyophilized Drug Products Read More »
Introduction Converting a peptide active pharmaceutical ingredient (API) from the trifluoroacetate (TFA) form to an acetate salt is an important
Introduction A thorough Extractables and Leachables Assessment of a peptide prefilled syringe generates the empirical chemical data necessary to support
Case Study: Extractables and Leachables Assessment for a Peptide Prefilled Syringe Read More »
Introduction Conducting a comprehensive Nitrosamine Risk Assessment and Trace-Level NDSRI Testing program is an essential regulatory and quality requirement for
