Single Use Solutions for Overcoming Challenges Associated with Manufacturing and Commercialization of Cell and Gene Therapy Products
12:00 PM – 1:00 PM |
Rapid advancements in cell and gene therapy development have resulted in recent product approval bringing these transformative medicines to market. Commercializing these products have introduced a new set of challenges unique to our industry. Single-use products and systems have proven to enable a more flexible and cost-effective approach to traditional bio-pharma manufacturing when certain manufacturing modifications are adopted. For example, low volume sample management systems, consisting of a ready to use sterilized solution prefilled to certain amount for addition to each step in a closed loop fashion, can be used to streamline the process with consistent quality output. Our presentation will provide an overview and detail several unique challenges currently facing the commercialization of these products including quality, logistics, contamination control and high costs of producing these transformative medicines.
Speaker: Timothy Korwan | Director, New Product Development | Avantor
Timothy Korwan is a Director of New Product Development at Avantor. Tim has 20+ years of experience as an engineer and business development with PAW BioScience Products, VWR and Biopure Corporation where he has designed single-use products, components, and systems that are used by the global drug and vaccine manufacturing industry.