Clinical Biomanufacturing & Cell Therapy Services

Clinical Biomanufacturing & Cell Therapy Services

WE CAN HELP

The Gates Biomanufacturing Facility was purposely built to strictly, safely, get promising therapies into clinical trials as quickly as possible. The suite of services we offer is focused on reliably, consistently producing this outcome.

CELL THERAPY AND PROTEIN PRODUCT PROCESS DEVELOPMENT, CONSULTATION, AND SUPPORT

  • Technology Transfer
  • Batch record creation and refinement
  • Develop manufacturing SOPs
  • Quality manufacturing process and analytical methods
  • Build and activate Bills of Materials and SOPs for orders to manufacture, collect, process, and release products to patients
  • Facility reference file with multiple cross-references

QUALITY CONTROL AND ASSURANCE

QUALITY CONTROL (ASSAYS AND TESTING):

  • Broad analytical capability and platforms that can be tailored for specific projects
  • In house environmental monitoring program

QUALITY ASSURANCE:

  • Robust electronic Quality Management System with cross-functional Quality Council
  • Dedicated Quality staff
  • All materials, equipment, and facility SOPs that would be expected of an industrial level Phase I facility

NEED HELP? HAVE QUESTIONS?

REGULATORY AND CLINICAL PROTOCOL SUPPORT

REGULATORY (FDA) COMPLIANCE AND SUPPORT:

  • Assist with pre-IND FDA meetings
  • Assist with Chemistry, Manufacturing, and Controls (CMC) section of IND preparation

 

CLINICAL PROTOCOL SUPPORT FROM FACILITY MEDICAL DIRECTOR:

  • Review clinical protocol
  • Ongoing study management and problem resolution

PROJECT MANAGEMENT

  • Customer service focus
  • Project Leader and communication point of contact
  • Scope Statements and/or Statement of Work
  • Project Plans
  • Clear direction and sustained focus on deliverables and timelines
  • Consistent communication