04.30.24 -- A Novel Approach To Managing Risks In Aseptic Processing Of Cell & Gene Therapies

Introducing our new Fill/Finish session! Outsourced Pharma Capacity Update’s new PARTNER WEEK offers an extended schedule and sessions grouped by capability including a day featuring the latest sterile filling, lyophilization, and advanced packaging technologies from CDMOs with current capacity for your manufacturing demands. Secure your spot for this session happening May 20th.

Jesse Mendelsohn, a "pharmaceutical regulatory compliance and government pricing” guru, who manages a life sciences group of over 100 consultants, says currently the biggest disruptor to our industry in 2004 is the Inflation Reduction Act (IRA), the 2023 legislation passed by Congress and signed into law by President Biden. 

When it comes to transporting highly sensitive and valuable materials, such as cell therapies, learn how teams can ensure that unique storage and distribution requirements are met.

Combined with the inherent difficulty of the chemistry behind gene therapy development, its pace, structure, and funding dynamics are unique among treatment modalities.

Discover a ready-to-use, suspension-based platform technology for transient transfection of LVVs that eliminates the need to transition from small-scale adherent processes.

Mathias Kahl, Director of Process Development, shares insights on overcoming challenges in AAV and LV viral vector manufacturing.

Avoiding the valley of death requires an early understanding of a drug’s proposed development process, as well as the potential pitfalls that could stall that development.

LVV manufacturing processes remain a significant hurdle for sponsors. Review the potential of a platform of packaging and producer cell lines designed to enhance LVV manufacturing efficiency.

Learn how a partner offering a comprehensive suite of integrated testing services designed to navigate the complexities of cell and gene therapies is critical for accelerating development timelines.

Committed to collaboration, Comprehensive Cell Solutions (CCS) combines the technology, expertise, and capacity you need to bring your novel cell therapies from discovery to commercialization.

Our team of experts can help you navigate the complex manufacturing and development lifecycle for cell and gene therapies from bench to bedside.