Streamlining Pharmaceutical Technology Transfer for Enhanced Drug Production

In the pharmaceutical industry, technology transfer is critical to ensuring that knowledge about product development and manufacturing processes is shared effectively across different phases and sites. Technology transfer aims to facilitate product realization by transferring essential process knowledge and control strategies between development and manufacturing teams and across manufacturing sites.

Collaborative Foundations for Success

The process begins with robust collaboration across multiple functions, including research and development, manufacturing, quality assurance, regulatory bodies, and commercial teams. From early development, it’s vital to assess unit operations at a commercial scale, identify Critical Quality Attributes (CQAs) and critical Process Parameters (CPPs), and establish a control strategy. This foundational work ensures that both the originating (sending) and recipient (receiving) units are equipped with a clear understanding of the product, process knowledge, and plans for mitigating risks.

Role Clarity and Relationship Management

Key to a smooth technology transfer is defining roles and responsibilities early, particularly between the sending and receiving units. Maintaining solid relationships within the transfer team is crucial for navigating the complexities of technology transfer, especially when it spans different cultural contexts.

Effective Team and Governance Structures

A formal technology transfer team should include leaders from both sending and receiving sites and Subject Matter Experts (SMEs) from areas such as Analytical Sciences, Engineering, Manufacturing, Quality, supply chain, and Regulatory Affairs. This team ensures comprehensive oversight and expert input essential for a successful transfer.

For governance, project leads and stakeholders must outline a clear framework encompassing the transfer’s scope, timelines, resources, budget, and success criteria. This framework should also include robust change and risk management strategies and a structured decision-making process.

Minimizing Changes Through Strategic Gap Analysis

Upon receiving the technology transfer package, the receiving unit conducts a gap analysis to compare existing and planned operational processes. This step helps identify knowledge gaps, process adaptations, and facility modifications. To ensure success, it’s critical to minimize changes. Keeping materials and manufacturing processes as consistent as possible with the original site helps maintain drug quality and integrity.

Effective technology transfer in pharmaceutical manufacturing is a strategic, structured process that extends beyond merely moving technology from point A to B. It involves detailed planning, skilled teamwork, and stringent management to ensure that every drug production phase meets the highest quality and efficacy standards. By adhering to these guidelines, pharmaceutical companies can achieve seamless technology transitions, ensuring consistent drug quality and availability in the market.

About the author

Elad Mark
COO at Scinai Pharmaceuticals Ltd.

Mr. Elad Mark served as Scinai Head of CDMO and COO, He is an executive leader and principal process engineer with over 15 consecutive years of biotechnology industry experience Including various technology transfer and scale up of biological product, green field facilities and aseptic processes design including cGMP manufacturing. Prior to joining Scinai, Mr. Mark led a technology transfer for Novartis’s $800 million investment in a biologics facility in Singapore, designed to support both clinical and commercial production of potential new products that include monoclonal antibodies

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