Biopharmaceutical process development – Trends/ Challenges/Opportunities
20th November 2019 | 10:30AM GMT/ 3:00PM IST | Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd and Sudhakar Nagaraj, Principal Scientist, SLS – Global Regulatory and Validation Consulting group at Pall Biotech |WATCH FOR FREE
- Current trends and regulation affecting Biopharmaceutical Industry
- Journey from Lab scale to Commercial –Overcoming Scalability design hurdles
- QbD-Bringing Improvements in Biologics development and Manufacturing Space
Presented by Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd
Kumar Gaurav is a seasoned professional with 15+ years of experience working in various capabilities in Drug Development and Regulatory Affairs functions in Vaccines and Biologics Industry.
He has played key leadership and strategic planning roles in development, scale up, technology transfer, devising regulatory strategies, operation and ensuring compliance. He comes with reliable knowledge base encompassing challenges, opportunities and unique requirements of the industry through various stages of product development from conceptualization, development strategy to scale-up, manufacturing operations, Quality compliance, Regulatory submissions extending further to commercialization, product registration and incremental innovation of marketed products including risk management at each stage.
He is creative problem solver and team player who thrive in diverse work environment. He exhibits well-developed and demonstrable executive leadership skills and strong background in product management with an extensive line-management experience along with a proven track record of significant achievements many of which are now a major part of the company’s vaccine portfolio and several others which are under various stages of Pre-clinical and Clinical trials gearing up for market launch.
Followed by Quality by Design (QbD) Approach for a Virus Filtration Application
Removal of viruses in bioprocessing applications is a fundamental regulatory requirement, and the use of virus filtration is considered a robust and well accepted component of a virus clearance strategy. With the advent of the International Conference of Harmonization (ICH) Q8 Pharmaceutical Development and Q9 Quality Risk Management guidelines, there is much greater emphasis for filter users to define the filter design space, in addition to performing the mandatory virus filtration validation studies.
A thorough understanding of the virus filtration design space not only alleviates the risk of viral contamination, but an in-depth understanding of the boundaries of the process parameters ensures the manufacturing process remains in control. In this webinar, we describe an approach to implement QbD principles into virus filtration to create a safe and robust biomanufacturing process.
Presented by Sudhakar Nagaraj, Principal Scientist, SLS – Global Regulatory and Validation Consulting group at Pall Biotech
Sudhakar Nagaraj has been involved in the pharmaceutical industry for over 17 years and has held positions of increasing responsibility in Pharmaceutical QC/QA, R&D, Validation and Regulatory affairs. He joined Pall’s Scientific Laboratory Services (SLS) organization in 2006. Currently, he is part of the SLS Global Regulatory and Validation Consulting team, which is focused on providing streamlined technical guidance and scalable, customer-focused solutions to facilitate customer specification, qualification, validation and regulatory approval using Pall technologies. Examples of customer-focused solutions include application risk assessments for adoption of Pall technologies, including consideration of extractables and leachables, toxicology assessments, complex filter validation support, customer-aligned change management, material compatibility information, and QbD/QRM support packages.
He is an active PDA India chapter member and represents Pall in Asia. He has completed post-graduation in Microbiology and is based in Bangalore, India.
Sponsored by Pall Biotech
Pall Biotech offers a blend of innovative traditional, single-use and continuous processing technologies and services to create scalable bioprocessing solutions that are flexible to each type of manufacturer’s process. From concept through to design, validation and production, our team leverages best-in class technologies with industry-leading support for all bioprocessing applications. Whether that means fast-tracking a new drug, helping to ensure regulatory compliance, or making existing processes easier, faster and better, we are ready to fulfill your unique needs. Want to learn more about how Pall Biotech can enhance your bioprocesses from start to finish?