Scalable, flexible manufacture: simplifying cell & gene therapy production

Sponsor

Many of the life sciences trends driving innovation today were here pre-COVID- the pandemic was merely an accelerant that opened numerous ‘proof of concept’ opportunities for tools, processes, and facilities alike.

Now, more than ever, speed and flexibility are at the forefront of current life sciences trends. Quick and effective implementation of solutions that benefit the health and well-being of the global population is imperative. Innovations like rapidly deployable and adaptive facilities enable companies to pivot and adapt to market needs with precision and ease.

In this webinar, we will discuss how facility design and project delivery are changing to keep up with the rapidly evolving life sciences industry, and what the future of flexible manufacturing looks like.Drawing on experience from over 300+ advanced therapy projects, we will discuss practical tips and design solutions showing the benefits of these facilities from both a CGMP and financial perspective.

How cell & gene therapy companies can scale strategically as their pipeline products advance through the development process
Design & construction considerations to improve commercial success
Learn about how to meet the demanding expectations of risk, quality, and performance with a set of curated best practices
Explore modular & podular facility options and configurations at different biomanufacturing scales
Learn how to quantify your resource needs as you scale out or pivot modalities
Create customized metrics to help right-size support spaces

JP Bornholdt, AIA, PE, LEED AP

Director, SlateXpace Technical Operations, CRB

JP Bornholdt is the Director of Global SlateXpace Operations at CRB. He creates pre-eminent solutions for the life science industry by working with project teams to apply innovative and disruptive approaches such as flexible design strategies, scalable turn-key technologies, modular, offsite fabricated, and integrated project deliveries. Licensed as both an architect and engineer, his expert knowledge of multiple disciplines provides a strong basis for integrated facility design and construction.

Niranjan Kulkarni, PhD

Director, Operations Improvement, CRB

Niranjan Kulkarni is the Director of Operations Improvement at CRB. He holds a doctorate and master’s degree in industrial and systems engineering from Binghamton University. He is also a certified Lean Six Sigma Master Black Belt. Niranjan has over 15 years of experience in business process and data modeling, operations and process simulations, process improvements, layout optimizations and supply chain management. Kulkarni has authored over 25 peer reviewed papers published in research journals, conference proceedings and industry periodicals. He is the co-author of the ISPE’s Good Practice Guide on operations management and has also co-authored a book chapter in the prestigious Lecture Notes in Computer Science series.

Carol Houts

Vice President of Quality & Business Strategy, Germfree

Carol Houts is the Vice President of Quality and Business Strategy for Germfree, an offsite clean room construction company that provides facility solutions for biopharmaceutical applications. Carol is an executive with over 25 years’ experience in pharmaceutical, and biologics product development, quality, regulatory affairs, and clinical research. Carol has worked intensively to have constructive and cooperative interactions with the FDA and other global regulatory agencies through formal meetings, regulatory submissions, inspections, and compliance remediation projects. Prior to joining Germfree, Carol has worked extensively to build companies organizational and service capabilities to increase revenue and sustain long-term growth. Carol has led business development activities to achieve funding and developed business plans for demonstrating investment opportunities.

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