Governance structures for global tech transfer and CMC alignment Governance structures for global tech transfer and CMC alignment In the pharmaceutical and biotechnology industries, the successful transfer of technology and effective management of CMC (Chemistry, Manufacturing, and Controls) are crucial for the commercialization of new therapies. This comprehensive regulatory explainer manual provides an in-depth overview of the frameworks, guidelines, and expectations for conducting comparative assessments and managing site changes associated with tech transfer and CMC. Regulatory professionals, particularly those involved with Kharma, will benefit from a structured analysis of CMC tech transfer comparability, bridging studies, comparability protocols, risk assessments, and…

Validation strategies for receiving sites in lifecycle CMC plans Validation strategies for receiving sites in lifecycle CMC plans In the pharmaceutical and biotech industry, successful product development and commercialization hinge on strict compliance with regulatory requirements throughout the product lifecycle. Central to this process is the understanding and execution of regulatory affairs (RA), particularly concerning change management in Chemistry, Manufacturing, and Controls (CMC). This article focuses on the nuances of CMC tech transfer comparability and the validation strategies for receiving sites during lifecycle changes. Context Chemistry, Manufacturing, and Controls (CMC) is a critical component of drug development and regulatory submissions….

Tech transfer considerations for biologics versus small molecule products Tech transfer considerations for biologics versus small molecule products Context In the pharmaceutical and biotechnology industries, tech transfer represents a critical phase in the lifecycle management of both biologics and small molecules. This process involves the successful transfer of processes, methods, and associated documentation from one facility to another, or from development to commercial production. As organizations scale their operations or transition from R&D to commercial manufacturing, understanding the regulatory expectations and scientific considerations paramount in this endeavor becomes crucial. This article provides an in-depth exploration of the CMC (Chemistry, Manufacturing…

Synchronising supply, quality and regulatory timelines during transfers Synchronising supply, quality and regulatory timelines during transfers The process of tech transfer and site changes in the pharmaceutical and biotech industries is critical for maintaining the supply of quality medicines while ensuring compliance with regulatory expectations. The necessity to balance operational efficiency with regulatory compliance often leads to complexities in managing CMC (Chemistry, Manufacturing and Controls) activities. This article delves into the intricacies of CMC tech transfer comparability, including bridging studies, comparability protocols, risk assessments, and receiving site validations. Through a structured examination, we will provide regulatory professionals with actionable insights…

Long term lifecycle view of network strategy and site CMC capabilities Long term lifecycle view of network strategy and site CMC capabilities This article provides a comprehensive overview of CMC tech transfer comparability, bridging studies, and comparability protocols within the regulatory landscape of the US, UK, and EU. Furthermore, it examines the critical role of Regulatory Affairs (RA) in maintaining compliance throughout the product lifecycle, particularly in the context of site changes and tech transfers. Context CMC (Chemistry, Manufacturing, and Controls) processes are essential in the pharmaceutical and biotech sectors, ensuring that products meet defined quality standards throughout their lifecycle….