Regenerative Medicine Development

Our Regenerative Medicine team offers comprehensive solutions to the unique and rapidly evolving non-clinical, manufacturing, regulatory, and clinical challenges with cellular, tissue, and gene therapy medicines. Our team employs a range of cell and molecular biological assays to enable the development and characterization of ancillary products (e.g., cell culture media) and novel therapeutics (e.g., advanced cell and gene therapies).

With the ability to leverage deep scientific knowledge, strategic partnerships and collaborations, and extensive clinical development experience with devices and biologics, we bring value added services to help accelerate development of your regenerative medicine products.

Our primary focus is the early stages of product development, helping sponsors move a product from concept to a successful IND submission and then on to early clinical evaluation. Our development services aim to reduce time, cost, complexity, and ultimately risk for sponsors at each project milestone or phase.

Regulatory and Clinical

Our Regenerative Medicine services support product, process, and method development. We leverage the experience and capabilities of our established service areas, such as regulatory and clinical, to drive our client’s development work forward, navigate the regulatory landscape, and meet business objectives.

Therapeutic Device Development

In instances where bespoke medical devices are required for the preparation and delivery of advanced cell and gene therapy products, we can draw from our medical device development and assembly capabilities to address this need for sponsors.

Non-Clinical Biological Studies

Our regenerative medicine non-clinical services cover planning and execution of in-vitro biological testing and in-vivo testing. We work with sponsors to focus preclinical studies on establishing and reinforcing a therapy’s putative mechanism of action, evidence of efficacy, proof of concept, and safety. Our aim is to help build a preclinical data package to prepare the therapy for human clinical study, and confidence that the therapeutic effect is superior to the current standard of care.

We offer comprehensive services that are designed to address sponsor non-clinical needs from product characterization to non-clinical safety testing and elucidation of probable mechanism of action. Biological testing capabilities encompass a range of cell and molecular biological assays that help enable the development and characterization of ancillary products and novel therapeutics.  We work with researchers and manufacturers to evaluate and select therapy-enabling technologies they can depend on from early-stage discovery through non-clinical development and commercial application.

Biological Study Services

• Process improvement
• Concept development and proof-of-concept
• Protein characterization
• Bioassay development (e.g., potency, purity, identity)

Publications and Presentations

• Rodenberg EJ, Patel DS, Shirley B, Young BW, Taylor AF, Steidinger HR, Fisher SJ, Patel AN. Catheter-based retrograde coronary sinus infusion is a practical delivery technique for introducing biological molecules into the cardiac system. Catheterization and Cardiovascular Interventions, 2019.
• Canestrari E, Steidinger HR, McSwain B, Charlebois SJ, Dann CT. Human Platelet Lysate Media Supplement Supports Lentiviral Transduction and Expansion of Human T Lymphocytes While Maintaining Memory Phenotype. Journal of Immunology Research, 2019.
• Thompson S, Klarer A, Smith D, Charlebois S, Steidinger H, Taylor A. Improving the quality cell yield of T-cell immunotherapies through selective pressures imparted by culture media supplements. Cell & Gene Therapy Insights 2020; 6(2), 287–294.
• Charlebois SJ, Canestrari E, Harris S. Characterization of a pathogen reduced human platelet lysate. Cytotherapy, Volume 20, Issue 5, Page S61, May 2018.
• Canestrari E, Charlebois SJ, Harris S. Human platelet lysate as a media supplement for ex vivo expansion of immune cells. Cytotherapy, Volume 20, Issue 5, Page S61, May 2018.
• Charlebois SJ, Ramachandran N, Hiles MC, McRoy W, Poderycki M, Steidinger H, Kuske J.Design verification and enhanced risk mitigation tests for cytocompatibility evaluation of cell delivery devices. Cytotherapy, Volume 16, Issue 4, Page S48, April 2014.