Life Science Expertise

Cell & Gene Therapy Product Development

Cell and gene therapies are on the cutting edge of translational research and will likely continue to be groundbreaking therapies in the coming years. The development of cell and gene therapies such as adeno-associated viral vectors, autologous and allogeneic chimeric antigen receptor cellular immunotherapies (REF), and stem cell-based therapies are technically and logistically complex. Thus, understanding and evaluating complete program requirements with respect to manufacturing process development, manufacturing partner selection, program and project management, regulatory strategy and market analysis, are critical in the ultimate success of a product.

LBG consultants are uniquely qualified to add key value in these crucial areas and provide subject matter expertise—from research and development to commercialization. LBG has demonstrated experience with multiple viral vector production systems, including over 14 years with AAV vectors alone. With the increased utilization of viral vectors for cellular modification, LBG is poised to support your cell and gene therapy programs.

Additionally, LBG has conducted key market research and analysis in the cell and gene space, and has insight into the products, vector requirements and the complexities surrounding the development of these products. This insight also includes valuable knowledge of the non-dilutive funding landscape and how to navigate it accordingly; which is a separate but related core competency of the LBG team.

LBG insights into cell and gene therapy field have extended to:

  • Creation of product development pathways and scenarios
  • Leadership and oversight of CMC activities
  • CMO selection / partnership
  • Non-dilutive funding opportunities
  • Late stage process characterization and validation strategies
  • Project management
  • Market and pipeline research on viral vector
  • General strategic consulting

REF: https://bioprocessintl.com/manufacturing/emerging-therapeutics-manufacturing/ebook-manufacturing-car-t-cell-therapies-insights-challenges/