USP <1663> and <1664> in Practice: How GMP Labs Apply Them to Extractable & Leachable Studies
Introduction: USP <1663> and <1664> E&L Testing is the analytical backbone that connects a packaging or delivery-system material to a […]
Single-Use Systems and GMP Extractables and Leachables (E&L) Testing: Managing Leachables Risk in Biologics
Introduction Single-Use Systems and GMP Extractables and Leachables (E&L) Testing establishes the analytical foundation necessary for detecting, identifying, quantifying, and
Designing a GMP-Compliant Extractables and Leachables (E&L) Study for Container Closure Systems
Introduction Designing a GMP-Compliant Extractables and Leachables (E&L) Study requires a structured, risk-based approach that brings together advanced analytical chemistry,
From Clinical to Commercial: Scaling Extractable & Leachable Testing with a GMP-Licensed Lab Partner
Introduction: Extractable & Leachable Testing for Clinical to Commercial Scale-Up is essential because changes introduced during manufacturing scale-up can alter
Designing a GMP-Compliant Extractables and Leachables (E&L) Study for Container Closure Systems
Introduction Designing a GMP-Compliant Extractables and Leachables (E&L) Study for container closure systems requires a systematic, risk-tiered analytical framework to
Case Study: Navigating Extractables and Leachables (E&L) Requirements for Single-Use Bioprocessing in a Cell Therapy Program
Introduction Extractables and Leachables (E&L) Requirements for Single-Use Bioprocessing in cell therapy programs define the analytical frameworks and risk assessment
Outsourcing Extractables and Leachables (E&L) Testing: Why CROs Choose a Health Canada DEL Licensed Lab
Introduction Outsourcing Extractables and Leachables (E&L) Testing to a Drug Establishment License (DEL) holder ensures that analytical data is generated
Case Study: Extractables and Leachables (E&L) Compliance for a Dry Powder Inhaler Seeking EMA Approval
Introduction Achieving Extractables and Leachables (E&L) Compliance for a Dry Powder Inhaler intended for European Medicines Agency (EMA) approval demands
Case Study: Resolving Extractable & Leachable Failures in a Prefilled Syringe System During Late-Stage Development
Introduction: Extractables and Leachables Testing for Prefilled Syringes has become an essential requirement for pharmaceutical companies developing injectable biologics, biosimilars,
Method Validation for Leachables Testing: What Regulators Expect from a GMP Lab
Introduction Method Validation for Leachables Testing in a Good Manufacturing Practice (GMP) laboratory provides documented, objective evidence that an analytical
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