Validations: Biologics, ATMP & Viral Safety Validation
Multiplex Assays and Omics: Fit-for-Purpose Validation Multiplex Assays and Omics: Fit-for-Purpose Validation The increasing complexity of biologics and advanced therapy medicinal products (ATMP) necessitates comprehensive validation strategies that adhere to regulatory requirements and ensure product safety and efficacy. This tutorial discusses the validation of multiplex assays and omics approaches with a focus on viral clearance validation, particularly in the context…
Statistical Models for Potency: Dose–Response and PLA Statistical Models for Potency: Dose–Response and PLA In the realm of pharmaceutical validation, the integrity of biopharmaceutical products hinges significantly on robust statistical models used in potency assessments. These assessments are critical not only for compliance but also for ensuring therapeutic efficacy and safety. This step-by-step tutorial will guide pharmaceutical and clinical professionals…
Outlier Management in Bioassays Outlier Management in Bioassays Introduction to Outlier Management in Bioassays Outlier management in bioassays is a crucial aspect of ensuring the reliability and compliance of biological products in the pharmaceutical industry. Biologics, including advanced therapy medicinal products (ATMP), often require stringent validation processes to confirm their potency and identity. This article serves as a comprehensive step-by-step…
Reference Change Triggers: ECs for Bioassays Reference Change Triggers: ECs for Bioassays Protocols for bioassays in the biopharmaceutical industry must adhere to rigorous standards to ensure product safety and efficacy. This article highlights critical aspects, including viral clearance validation, and addresses the complexities introduced within the scope of single-use and closed systems. In addition, our focus is on establishing a…
Documentation for Potency/Identity in Filings Documentation for Potency/Identity in Filings The validation of potency and identity in therapeutic biologics, including advanced therapy medicinal products (ATMPs), is crucial within the pharmaceutical industry. This step-by-step tutorial guide aims to provide comprehensive insights into the necessary documentation practices for potency and identity in regulatory filings, ensuring compliance with US FDA, EMA, MHRA, and…
Specification Setting for Potency/Identity: Guardbands Specification Setting for Potency/Identity: Guardbands The correct specification setting for potency and identity is critical in the development and validation of biologics, including Advanced Therapy Medicinal Products (ATMPs). Utilizing guardbands provides a systematic approach to ensure product quality that aligns with regulatory standards set forth by the FDA, EMA, and other authorities. This tutorial will…
Stability-Indicating Behavior for Complex Assays Stability-Indicating Behavior for Complex Assays Introduction to Stability-Indicating Behavior in Biologics Biopharmaceuticals, especially Advanced Therapy Medicinal Products (ATMPs), pose unique challenges in validation processes primarily due to their complexity and variability. Among these challenges, the assessment of stability-indicating behavior for complex assays is critical in ensuring product safety and efficacy. Stability testing plays a vital…
Sampling & Handling for Biologics/Cells: Cold Chain Hooks Introduction to Cold Chain Management in Biologics The management of cold chain logistics is critical in the field of biologics and advanced therapy medicinal products (ATMPs). This step-by-step guide will provide insights into effective sampling and handling strategies for ensuring the integrity and reliability of biologics during transport and storage. As regulations…
Bioassay Lifecycle: Monitoring, Re-Validation, and Drift Introduction to Bioassay Lifecycle The bioassay lifecycle is a vital component in the development and commercialization of biologics and advanced therapy medicinal products (ATMP). Understanding the monitoring, re-validation, and drift aspects of bioassays is crucial for ensuring compliance with regulatory frameworks like the FDA, EMA, and MHRA. This article outlines a systematic approach to…
Digital Readouts & Imaging Assays: Validation Considerations Digital Readouts & Imaging Assays: Validation Considerations The pharmaceutical and biotechnology industries are continually evolving, particularly concerning the validation of complex systems and assays. In this guide, we will explore crucial validation considerations for digital readouts and imaging assays, particularly as they pertain to biologics, advanced therapy medicinal products (ATMPs), and viral clearance….