Harmonizing Biologics Transfer: Global Regulatory Strategy, Compliance Best Practices, and Operational Alignment with Gopi Vudathala, Incyte Corporation

About the Interviewee

Gopi Vudathala is the Global Head of Regulatory Affairs and Chemistry, Manufacturing and Controls at Incyte Corporation.

Gopi Vudathala, Ph.D., serves as the Global Head of Regulatory Affairs and Chemistry, Manufacturing and Controls (CMC) at Incyte Corporation, a biopharmaceutical company dedicated to the discovery, development, and commercialization of proprietary therapeutics across oncology and inflammation. Dr. Vudathala holds a B.Pharm in Pharmacy from Bangalore University and earned his Ph.D. in Pharmaceutics and Drug Design from the University of Alberta, where he was elected President of the Indian Graduate Students Association and served as Student Representative to the University Graduate Research Committee.

Dr. Vudathala brings over three decades of global regulatory CMC and quality leadership spanning small molecules, biologics, vaccines, and drug-device combination products. His previous roles include senior regulatory positions at Intarcia Therapeutics, Sanofi, Novartis, GSK Vaccines, and Procter & Gamble Pharmaceuticals. Across these roles, he has led the successful filing and maintenance of worldwide DMFs, INDs, CTAs, NDAs, BLAs, and MAAs. He is especially recognized for his strategic expertise in Quality-by-Design (QbD), genotoxic impurity control, ISO/CFR compliance, and regulatory interface management across the full product lifecycle.

In addition to his role at Incyte, Dr. Vudathala has served as Vice President of Regulatory Affairs at DSInpharmatics and was the founder of XCell Pharma Consulting LLC, where he provided global CMC regulatory and quality systems consulting for drug, biologic, and device developers. His cross-sector insights and collaborative leadership have supported numerous health authority interactions, inspection responses, and regulatory policy initiatives, positioning him as a global thought leader in the regulatory sciences space.

At Incyte, Dr. Vudathala leads global teams in developing and executing regulatory CMC strategies to ensure compliance, accelerate approvals, and enable timely delivery of innovative therapies to patients worldwide. He remains a strong advocate for regulatory innovation, systems thinking, and science-based policy to strengthen the global biopharmaceutical ecosystem.

The Discussion

Journey to Global Head of Regulatory Affairs at Incyte Corporation

[Dex Marco]: It’s such a pleasure to have you here with us today, Dr. Vudathala. So, Gopi, with your extensive career in regulatory affairs and global leadership experience, what inspired you to pursue this field, and how has your journey led you to becoming the Global Head of Regulatory Affairs at Incyte Corporation?

[Gopi]: Thank you and it is a pleasure to be discussing my career journey and experience with PharmaFEATURES. I have always wanted to be in the medical field serving people and patients. I have worked with several large, mid-size and small-size multi-national pharmaceutical companies in various capacities. My dedication, commitment and leadership qualities led me to effectively provide leadership to large regulatory CMC groups, managing and guiding the development, life-cycle management & maintenance of pharmaceutical products.

Key Pillars of Effective Biologics Technology Transfer

[Dex]: Effective communication and meticulous planning form the backbone of a successful biologics technology transfer process. Could you elaborate on how these elements contribute to a seamless transfer process and how you ensure all stakeholders remain aligned throughout the project?

[Gopi]: Communication & planning are key aspects in any pharmaceutical operation and the importance of these are more so emphasized for technology transfers across sites and either the same or different companies/organizations. A clear transfer plan needs to be established for any biologics technology transfer and communicated well with the receiving site(s). All considerations for the technology transfer plan, the potential challenges, and opportunities for improvement of the processes should be conveyed accurately to the receiving organization. It is important that the trained personnel in the previous location be involved in ensuring a smooth transfer of the operations to the staff in the new site(s). Appropriate trainings of the new staff/operators and frequent communication and collaboration across the site personnel and experts will ensure a successful technology transfer.

Facility Readiness and System Suitability

[Dex]: Encompassing everything from the physical infrastructure and equipment to utilities and environmental controls, facility systems and their suitability play an indispensable role in ensuring the success of manufacturing processes. What are the primary challenges in ensuring facilities are adequately equipped and compliant for biologics technology transfer, and how do you address these challenges?

[Gopi]: We need to ensure that all facilities manufacturing drug/biologic products are compliant with cGMP requirements. All equipment in the new facilities should have had an Installation Qualification and an Operational Qualification performed and then with the technology transfer of the biologic, to have a Performance Qualification done. It would be important to ensure the appropriateness of capacity requirements and all facility service systems. As biologics are in large part, parenterals, extreme caution should be taken to ensure containment and sterile operations within the new site. Testing and maintenance would become constant operations, and of course, continuous performance improvements, and process verifications will need to be periodically conducted.

Equipment and Process Considerations

[Dex]: Given the complexity of biologics manufacturing, what are the essential factors to consider when adapting equipment and processes during technology transfer, particularly in ensuring scalability, compliance with regulatory standards, and alignment with product-specific requirements? How do you approach ensuring compatibility while maintaining product integrity throughout the transition?

[Gopi]: As part of the planning process, suitable equipment for purpose and scale, should be selected for installation at the new site. Product characteristics and equipment suitability for manufacturing needs to be taken into consideration. Appropriate process controls, in-process controls and quality attributes must be established, and data compared with the biologic being manufactured at the previous site. The choice of equipment to ensure compatibility and integrity of the product will need to be considered.

Controlling Critical Parameters

[Dex]: Monitoring critical process parameters (CPPs) and critical quality attributes (CQAs) is essential for ensuring consistent process performance and maintaining high product quality. How do you define and optimize these controls during biologics technology transfer to meet stringent regulatory and quality standards?

[Gopi]: The CPPs and CQAs established for the product, based on development and experience at the previous site, can be utilized to mirror at the new site. However, there may be slight changes necessary based on equipment and process capabilities at the new site. These will need to be continuously evaluated as the transfer process proceeds, and to be fixed, to ensure appropriate product comparability and the regulatory standards in the applications.

Process Qualification and Validation

[Dex]: Process qualification and validation ensure that all critical parameters are consistently met, risks are mitigated, and product quality is maintained throughout the manufacturing lifecycle. What strategies do you employ to streamline these processes and address challenges such as scale-up and reproducibility in biologics production?

[Gopi]: It may be necessary to run a few development/engineering batches to evaluate and compare to the product at the previous site. The confidence in the process gains with experience and this will greatly help to ensure Process Performance Qualification/Validation. Timely evaluation of the development documentation will be necessary to define the process qualification protocols which take into account the scale-up and reproducibility. Minimizing errors and deviations during the technology transfer process are key to ensure the quality and reproducibility of the biologic production.

Navigating Global Regulatory Challenges

[Dex]: As regulatory landscapes differ across regions, what are the most significant global regulatory challenges you face in biologics technology transfer? Could you share best practices for navigating these complexities while ensuring compliance and efficiency, and how do you foresee these challenges evolving with future regulatory shifts?

[Gopi]: Global regulatory challenges exist due to differences in regional and local regulations, which is something Industry would need to collaborate with Regulatory Agencies to minimize/eliminate.

Establishing and maintaining good communication with Authorities, such as meetings and invitations to tour the facility at various phases will help to resolve any key regulatory challenges or blocks. As facilities are being built and equipment is being installed, giving the local/country Regulatory Authorities the ability to conduct site inspections and provide comments and suggestions builds a great rapport that certainly helps in the long run as they come for any pre-approval, or if required, post approval inspections. As much as possible, we need to standardize the process and establish controls that are broadly accepted by global regulatory agencies. A narrowing of differences of regulatory requirements across global regions will greatly reduce the regulatory burdens for Industry.

Future Perspectives in Biologics Technology Transfer

[Dex Marco]: Dr. Vudathala, looking toward the future, how do you envision advancements in technology and regulatory frameworks transforming biologics technology transfer as Global Head of Regulatory Affairs at Incyte? Are there particular innovations or trends you see playing a critical role in enhancing the speed and success of these transfers?

[Gopi]: Several of the principles mentioned above address this question. Certainly, advancements in technology are continually evolving which hopefully, will minimize manual/human errors and result in a more robust technology transfer and manufacturing process, once implemented. The utilization of AI (Artificial Intelligence) offers significant opportunities for continual improvement in the technology transfer process, but this remains to be tested.

Thank you for the very thoughtful questions and I hope I have addressed these well.

Engr. Dex Marco Tiu Guibelondo, B.Sc. Pharm, R.Ph., B.Sc. CpE

Editor-in-Chief, PharmaFEATURES

Join Proventa International’s Chemistry, Manufacturing, and Controls Strategy Meeting at Le Meridien Boston, Cambridge, Massachusetts on the 7th of May 2025 to learn more about Incyte Corporation.