Validations: Closed Systems, Single-Use & Aseptic Controls
Storyboards: Closed System Transformations Storyboards: Closed System Transformations Introduction to Closed Systems and Aseptic Controls The field of pharmaceutical validation emphasizes the importance of maintaining product integrity, especially in the realm of biologics, Advanced Therapy Medicinal Products (ATMPs), and viral safety. Closed systems and single-use technologies have emerged as critical elements in ensuring aseptic processing and preventing contamination. This article…
Storyboards: Closed System Transformations Storyboards: Closed System Transformations Introduction to Closed System Transformations in Biologics and ATMPs Closed systems and single-use systems are increasingly pivotal in the biopharmaceutical industry, especially in the context of advanced therapy medicinal products (ATMPs) and their validation processes. The regulatory landscape surrounding these technologies is complex, requiring a thorough understanding of aseptic controls, viral clearance…
Top Closed System Gaps—and Durable Fixes Top Closed System Gaps—and Durable Fixes Introduction to Closed Systems in Biologics and ATMP Validation The evolving landscape of biologics and advanced therapy medicinal products (ATMP) necessitates a meticulous approach to validation, especially when dealing with closed systems. Closed systems provide a controlled environment to minimize contamination risks, which is vital in aseptic processing….
Top Closed System Gaps—and Durable Fixes Top Closed System Gaps—and Durable Fixes This article is a step-by-step tutorial guide designed to assist pharmaceutical professionals in understanding the validation of closed systems, particularly focusing on aseptic controls relevant to biologics and Advanced Therapy Medicinal Products (ATMP). As the biopharmaceutical landscape evolves, adherence to regulations from the FDA, EMA, and MHRA is…
Closed Filling for Cell/Gene Therapies Introduction to Closed Filling Systems Closed filling systems are critical in the manufacture of cell and gene therapies (CGTs), as they provide an exceptionally controlled environment that minimizes exposure to contaminants during the filling process. The use of closed systems is becoming increasingly important due to the heightened focus on patient safety and product integrity….
Component Sterilization Assurance: SAL and Evidence Component Sterilization Assurance: SAL and Evidence Ensuring the safety and efficacy of biopharmaceutical products, particularly in the realms of biologics and advanced therapy medicinal products (ATMPs), is paramount. Sterilization processes must yield a sterility assurance level (SAL) that guarantees the inactivation of potential contaminants. This article outlines a step-by-step tutorial on achieving sterilization assurance…
Single-Use Change Control: Lots, Models, and Equivalence Single-Use Change Control: Lots, Models, and Equivalence In the ever-evolving landscape of biologics and advanced therapy medicinal products (ATMP), the implementation of effective single-use systems is paramount for maintaining compliance with stringent regulatory expectations. As outlined in EMA’s guidelines, understanding single-use change control mechanisms, including lot variations and model equivalence, becomes critical. This…
Supplier Qualification for Single-Use Components Supplier Qualification for Single-Use Components In the rapidly advancing field of biologics and advanced therapy medicinal products (ATMPs), ensuring the qualification of suppliers for single-use components is paramount. This step-by-step guide aims to provide pharma professionals with a systematic approach to supplier qualification, emphasizing aspects such as viral clearance validation, aseptic controls, and critical quality…
End-to-End Traceability for Single-Use Assemblies End-to-End Traceability for Single-Use Assemblies In the rapidly evolving landscape of biopharmaceuticals, ensuring the safety, efficacy, and quality of drug products is paramount. The growing adoption of single-use systems (SUS) has offered significant advantages in terms of flexibility and reduced contamination risks. However, this trend also brings forth complex challenges related to aseptic processing and…
Cleanroom Classification for ATMP Suites Introduction to Cleanroom Classification in ATMP Facilities As the biopharmaceutical landscape continues to expand, particularly in the area of Advanced Therapy Medicinal Products (ATMP), the importance of stringent cleanroom classifications cannot be overstated. Aseptic processing environments are critical for maintaining the quality and safety of biologics, necessitating compliance with FDA, EMA, and other regulatory standards….