Filling a critical gap: core competencies and strengths

Providing consistent production under the CCBC Cell Therapy Incubator adds value by decreasing time to market, overcoming regulatory hurdles and developing quality products by leveraging Cleveland Cord Blood Center (CCBC) experience and diverse affiliations/partnerships. CCBC aims to apply the same principles to the yet evolving, but rapidly advancing field of cell therapy and regenerative medicine.

The Cell Therapy Incubator offers:

  • An independent Cord Blood Bank with FDA BLA approved; FACT and AABB accredited manufacturing; and medical/quality oversight programs
  • Lean and efficient operations with limited red tape in urgent situations/emergencies, facilitating HPC Cord Blood shipment within 24 hours upon request
  • Established research programs utilizing CD34 isolation from cord blood for preclinical modeling
  • Cell therapy lab equipped and under an active environmental program with minimal time required to program readiness for GMP manufacture of clinical grade products
  • Demonstrated in-house experience in clinical outcome monitoring and reporting

Existing Infrastructure & Expertise

The Cell Therapy Incubator supports cell-based therapies in regenerative medicine with controlled facilities and expert oversight, providing consistent production under Good Manufacturing Practice (GMP) of early stage products, including:

  • Critical expertise in all stages of clinical development
  • State-of-the-art facility
  • Raw materials
  • Procurement and management
  • Methods and equipment validation
  • Design of manufacturing protocols
  • Product stability testing program development
  • Report creation for regulatory applications and filings
  • Quality and regulatory compliance
  • Shipping and logistics