Regenerative Medicine

Regenerative medicine combines engineering and life science principles to restore tissue and organ function lost through trauma, age, disease, or genetic disorders. The opportunities presented by tissue engineering and regenerative medicine are expanding rapidly. The U.S. Food & Drug Administration (FDA) has developed a comprehensive policy framework which is intended to allow the introduction of safe and effective human cells, tissues, and cellular and tissue-based products (HCT/Ps) to market. More than 200 Investigational New Drug (IND) applications are expected to be submitted per year from 2020 on and 10 to 20 cell and gene therapy product approvals are expected per year by 2025 in the U.S. and Europe.
Regenerative medicine consists of three main categories: cell therapies, gene therapies, and engineered products. Cell therapy is the administration of autologous or allogenic cells that include stem cells, induced pluripotent stem cells (iPSCs), and reprogrammed cells. Gene therapy involves the targeting and modification of genetic material using DNA, RNA, and specific delivery vectors. Tissue engineering is the use of cells, scaffolds, or biologics to promote wound healing, tissue repair, and regenerative pathways.

The regenerative medicine market faces key challenges, including navigating regulatory pathways, the need for a multi-disciplinary approach, and coordinating animal and clinical testing. Exponent is uniquely qualified to address these challenges. Our team can help our clients develop and characterize their devices and therapies in vitro and in vivo, provide technical assistance for existing products, and conduct regulatory and risk assessments pre- and post-market. Our wide range of capabilities and expertise allows Exponent to deliver results to our clients with speed and rigor.

Services and Expertise

General

Development and implementation of custom testing fixtures
Performance of gap and root-cause analyses
Health economics and reimbursement strategy
Complete small-scale materials test facility with environmental control
Quality, Risk, and Regulatory Management Support

Biomaterials

Evaluation and characterization of 3D and 2D structures from naturally derived and synthetic materials as well as biologic tissues
Characterization of mechanical properties (static and dynamic)
Characterization of microfluidic and microscale systems
Evaluation and characterization of bioreactors and finite element analysis of mass transfer
Constitutive modeling (linear and non-linear) of isotropic and aligned constructs
3D printing/bioprinting
Drug delivery (loading and release)

Tissues

Physical, chemical, and mechanical characterization of tissues
Histological analysis

Cells

Epi fluorescent microscopy techniques including confocal microscopy
Characterization of cells, cellular aggregates, and tissue response to the mechanical environment
Characterization of cells and tissues to the environment through:
  • Mechanical testing
  • Assaying for matrix protein accumulation
  • Measurement of radiolabel incorporation to determine biomatrix synthesis

Signaling

Real-time physiologic measures using fluorescent intra-extracellular probes
Characterization of cellular responses to soluble factor gradients
Cell migration assays and autocrine/paracrine interaction assay development

Professionals

Knowledge