INSIGHTS ON CELL & GENE MANUFACTURING

  • Road To Success: Understanding Good Laboratory Practice For Cell And Gene Therapies

    Given the complexity, diversity and rapid change of technology and techniques for cell and gene therapy (CGT) products, such standardization is often difficult (but not impossible!) to achieve. With key considerations, GLP studies enable investigational new drug (IND) and clinical trial application (CTA) filings and human clinical trials.

  • Integrated Pluripotent Aggregate Processing With The ekko™ System

    Pluripotent stem cells (PSCs) and induced pluripotent stem cells (iPSCs) are promising sources for the next wave of cell therapies and regenerative medicine. As with many cell therapies, one major technical hurdle is the scalable production of PSCs for commercial applications, specifically when processing these cell types in aggregate form. Read how the ekko™ system enables automation of the media exchange and subsequent harvest steps. The system is a functionally closed, integrated manufacturing platform which gently processes cell aggregates and provides the option to remove any free single cells.

  • Reducing Risks With Single-Sourced Modular Cleanrooms

    Life sciences industries require highly controlled environments for drug research development and manufacturing.

  • Process Impurities: Don’t Let PEI Or HCP Derail Your Biotherapy

    This presentation addresses product characterization strategies to de-risk the manufacturing of mAbs and cell and gene therapies. It also covers detection and characterization of host cell proteins (a factor in mAb therapies and cell and gene therapies), and polyethylenimine used in cell and gene therapies.

  • Droplet Digital Polymerase Chain Reaction

    Leveraging the hyper accuracy of Droplet Digital PCR (ddPCR), viral and gene therapy developers gain additional confidence in tittering assays and vector copy number determination.

  • Scale Your Bioproduction With Large Format High-Flow Connectors

    Looking to scale up your liquid bioprocessing and decrease transfer times? Learn how high-flow, genderless, large format connectors make scale and efficiency easy and reliable.

  • Outsourcing Trends For Cell & Gene Therapy

    The cell and gene therapy sector’s focus on outsourcing is a major area of on-going concern due to the shortage of suitable manufacturing facilities and qualified outsourcing staff.  This collection of original articles from Cell & Gene weighs the economic benefits of outsourcing (i.e. productivity, efficiency, time-to-market, and quality gains) as well as best practices for selecting an outsourcing partner. Here you’ll find information about the current limitations associated with a complicated manufacturing process as well as existing and promising opportunities and developments needed to outsource most — if not all components — of the value chain.

  • Making AI Usable For Pharma and Biopharma

    Artificial intelligence (AI) is already making a huge contribution to the global economy, even though this development is still in its early stages. AI is a kind of turbo drive for the new digital technologies, because it enables machines to imitate human decision-making processes. This white paper explores how to use artificial intelligence to uncover hidden business value in the regulated pharmaceutical and biotech industries.

  • 3 Keys To Realizing FDA’s Vision For CAR-T And Other ATMPs

    While cell therapy remains a very promising approach to developing much-needed new immunotherapies, significant challenges will have to be overcome in order to realize the FDA’s twenty-first century vision of making complex ATMPs widely and cost effectively available to patients.

  • Development Of A Modular, Semi-Automated And Closed T-Cell Manufacturing Strategy

    The rapid clinical advances of T-cell based immunotherapy necessitate robust manufacturing solutions that are suitable for commercial scale production. Here, we present a modular manufacturing process using commercially available equipment that is suitable for the production of CAR T-cells or other T-cell based therapies and amenable for rapid implementation to therapeutic developers’ specific processes.