Analytical Run Acceptance Criteria in Regulated Bioanalysis: QC Levels, Placement, and What ICH M10 Requires
Introduction Under the harmonized ICH M10 guideline, which was adopted at Step 4 on May 24, 2022, issued by the […]
Calibration Curve Design and Regression Weighting in LC-MS/MS Bioanalysis: Getting the Fit Right
Introduction Effective Calibration Curve Design and Regression Weighting in LC-MS/MS bioanalysis requires matching the mathematical order of the calibration function
Polymorphism and Solid-State Characterization in CMC: Why Crystal Form Matters for Drug Approval
Introduction: Polymorphism solid-state characterization CMC work answers one regulatory question: is the crystal form of your drug substance known, stable
ICH Q11 and Q8 Guidelines in CMC Drug Development: A Practical Overview for Sponsors
Introduction: The ICH Q11 CMC drug development guidelines, read together with ICH Q8(R2), explain how sponsors should design, justify and
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CMC Consulting Services for Biotech Startups: How to Choose the Right CRO Partner
Introduction: Choosing among CMC consulting services for biotech startups comes down to one question: which partner can turn your science
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How Much Does Peptide Manufacturing Cost with a US CDMO?
Introduction Understanding Peptide CDMO Cost / Pricing in the United States involves examining a complex financial landscape in which preclinical
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Top Things to Look for in a GMP Peptide CDMO Partner
Introduction Evaluating a contract development and manufacturing organization (CDMO) for peptide active pharmaceutical ingredients (APIs) involves more than assessing conventional
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CMC Due Diligence Support for Pharma Licensing Deals and Investor Audits
Introduction CMC Due Diligence Support involves a comprehensive assessment of the technical, regulatory, and quality aspects of drug substance and
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Case Study: Overcoming Polymorphic Instability During NDA CMC Review for an Oral Solid Dosage Form
Introduction Overcoming Polymorphic Instability During NDA CMC Review requires the implementation of orthogonal solid-state characterization protocols, validation of robust crystallization
CMC Requirements for 505(b)(2) NDA Pathway: What Makes It Different from a Full NDA
Introduction: The CMC requirements 505(b)(2) NDA applicants must satisfy are the same quality standards that apply to any new drug
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