Efficiency by Design – Case Study for a Hybrid Clinical Manufacturing Facility
09th November 2018 | 10 AM EST | Dr Sourav Kundu, Senior Director, Process Development and Clinical manufacturing at Teva Pharmaceuticals and Adam Kaletski, Business Leader, Bioprocess Hardware and Enterprise Solutions at GE Healthcare |WATCH FOR FREE
Clinical manufacturing facilities require the flexibility to configure the sequence of unit operations as well as equipment characteristics to fit diverse types of manufacturing processes.
While stainless steel facilities remain as more traditional and suitable for large volume products, single-use facilities provide tremendous advantage for flexibility, infrastructure and capital costs, and start-up time.
Single-use equipment and single-use facilities are particularly suitable for clinical manufacturing due to smaller investment requirements, smaller footprint, reduced risk, and increased operational flexibility.
While single-use equipment are evolving and catching up to the functionality and reliability of stainless steel equipment, in some instances, stainless steel equipment may still be preferred.
We will be providing a description of a new clinical manufacturing facility where single-use and stainless steel equipment were combined in a strategic manner to meet the business objectives.
Biopharmaceutical manufacturing facilities are designed and operated to meet business objectives at various stages of a product lifecycles. While large stainless-steel facilities are appropriate for large volume established products, smaller single-use facilities are more efficient for smaller volume manufacturing needs, particularly for clinical supplies. Stainless steel equipment can be combined with single-use equipment to create hybrid facilities to meet process needs and business objectives in a more efficient manner. Typical challenges with building and validating a biopharmaceutical manufacturing facility can be overcome by strategic planning, good execution and a high-performance team.
Presented by Dr Sourav Kundu, Senior Director, Process Development and Clinical manufacturing at Teva Pharmaceuticals
Sourav Kundu, Ph.D. is a Senior Director at Teva Pharmaceuticals Global Biologics R&D. He directs a development team involved in cell culture process development from clone to commercial. He also heads the clinical manufacturing for biologics at Teva. Sourav has over 25 years of industry experience and has been involved in development and commercialization of multiple biologic drugs. Prior to Teva, Sourav was a Director of Process Development at Amgen. He also held positions with increasing responsibilities at Aventis and Baxter.
Sponsored by GE Healthcare
About GE Healthcare Life Sciences
The Life Sciences business of GE Healthcare provides a wide range of bioprocessing products and services that enable the development and manufacture of high-quality biotherapeutics and vaccines. Using our knowledge and expertise, we support our customers in increasing speed to market, while avoiding unnecessary costs and improving quality and performance in drug manufacturing. As a provider of high-quality products, customized technical and commercial services, as well as design and construction of complete biomanufacturing solutions, we support the biopharmaceutical industry in making health visions a reality.
Practical considerations in hybrid manufacturing
Strong growth is expected to continue in the biologics market along with an increased focus on speed and efficiency. To succeed, biomanufacturers are looking for dynamic production capabilities with unique approaches and new technologies, that will support flexible production and minimize time-to-market. The need to balance efficiency and flexibility in this type of environment often favors a hybrid processing approach.
This discussion will review;
- economics of single use versus stainless steel
- benefits of a parallel production pathway (facility and process development)
- why standardization is better for cost and speed
- deciding factors for building or outsourcing
Presented by Adam Kaletski, Business Leader, Bioprocess Hardware and Enterprise Solutions at GE Healthcare
Adam Kaletski leads the Bioprocess Hardware business at GE Healthcare in North America. He directs a team of scientists and engineers that deliver solutions to help customers solve their development and manufacturing challenges. Adam has been designing systems and technologies in numerous industries for over 30 years. He has spent the last 23 years with GE Healthcare, delivering innovative solutions for the Pharmaceutical and Biotech industry. He holds several patents around bio manufacturing technologies and holds a Bachelor of Engineering in Electrical Engineering and Computer Science from Stevens Institute of Technology.