INSIGHTS ON CELL & GENE MANUFACTURING

  • Time to Start Clearing Bottlenecks in Cell and Gene Therapies

    With the increasing pace of new cell and gene therapies (CGT) receiving approvals and in development, the current capacity of the CGT ecosystem is unable to keep up with the clinical and commercial products coming to market. 

  • Clinical Strategy For Successful Cell And Gene Therapy — How Did I Get Here?

    There are major challenges to the widespread adoption of cell therapies, primarily related to the high manufacturing costs of what is largely a manual process with complex logistics and supply chain. Experts share their experiences and discuss emerging trends in the field to accelerate life-saving therapies from the bench to the bedside.

  • Strategies For Startups — How To Structure Milestones For Successful Outcomes

    Experts from the cell and gene therapy field share their experiences and discuss trends to accelerate therapies from the bench to the bedside, with specific focus on strategies for start-ups, how to look at robust scale-up, and reducing CMC risk.

  • Attracting The Right Capital — Forming Partnerships For Long-Term Success

    Experts share their experiences on investing in the cell and gene therapy field and how to form long-term partnerships for companies on the path towards bringing a potentially life-changing therapy to patients.

  • Maximizing Product Titre By Strategic Control Of Osmolality In Mammalian Cell Bioprocesses

    Osmolality is a key process parameter in mammalian cell bioprocesses that affects both specific cell growth and specific cell productivity. Published data shows that hyperosmolality, used in a targeted way at particular stages of the biological production process, for certain cell types, can enhance final product yield significantly. This presentation reviews the strategies that can be used to manipulate osmolality to increase production yields of monoclonal antibodies and other recombinant proteins.

  • Osmolality: A Predictor In Mammalian Cell Culture

    In this presentation we explored the quality and significance of osmolality as a predictor for titer, glucose consumption, and growth-inhibitory by-products such as ammonium in mammalian cell culture. The measurements of different runs were used to establish correlations with osmolality and independent runs to test the predictive power of osmolality. Interestingly the osmolality is a good predictor for glucose, ammonium, and dissolved CO2 among others with a weaker power. The implementation of osmolality measurement and its application in bioprocessing is also discussed.

  • Upstream Applications Of Osmolality Testing In Cell & Gene Therapy Processes

    Osmolality can be used as a versatile, robust tool to help improve cell and gene therapies, adding a necessary and beneficial process parameter. This presentation focuses on the incorporation of osmolality testing into upstream applications which include media development, feeding strategies, and the minimization of aggregation.

  • Consistency And Compliance Through Cell Therapy Automation Software

    As automation offers new options for flexibility and optimized production in biologic production, exploring its use in advanced therapy manufacturing to improve safety, quality, and compliance becomes a key factor in advancing patient care.

  • CCRM And Amgen Partner To Advance Emerging Medical Innovations

    CCRM, a leader in developing and commercializing regenerative medicine-based technologies and cell and gene therapies, and Amgen, a global leader in the biotechnology industry, are announcing a multi-year fund, for early-stage regenerative medicine-based technologies and therapies to benefit patients and the health-care system.

  • The Critical Roles Of cGMP Chemicals And Single-Use Technologies In Cell & Gene Therapy Manufacturing

    Ensuring transformative medicines make it to the patients who need them requires risk mitigation strategies that not only improve the quality of raw materials but also facilitate scale-up processes in order to meet global demand.