Welcome to WEJCGTCS – WEJ Cell and Gene Therapy Consulting Services, LLC.
At WEJCGTCS we bring over 30 years of experience in the field of cell based therapies to provide assistance to both commercial and academic based organizations working to bring advanced therapies to patients. Areas in which we bring experience based expertise include:
REGULATORY:
WEJCGTCS provides assistance with the regulatory process, ranging from actual technical writing to review and editing of regulatory applications preparatory to filing. Possible services may include:
- Assistance with preparation for pre-application interactions with FDA
- Writing text for application
- Preparation of data for presentation in application
- Review and editing of completed application sections
- Application compilation
SUPPORTING STUDIES AND ANALYSIS
The lifecycle of any therapeutic agent includes numerous points wherein it is necessary to provide experimental evidence to support methodology design, selection of in-process and product release analytics, and comparison studies to name a few. Because of the inherent variability in the most critical starting material for cell-based therapeutics, namely cells, these studies and their associated analysis are less straightforward than for conventional pharmaceuticals. Possible services may include:
- Design and analysis of comparison studies such as when making changes in manufacturing methodology or when moving production to a new facility
- Review of analytics to determine best assays for process monitoring and/or for product release testing
- Assistance with developing potency assays
- Review and analysis of stability monitoring programs
- Development of statistics based prospective quality management programs
- See how WEJCGTCS manages client data by clicking here
FACILITY DESIGN AND OPERATION
There is much more to having a compliant and functional facility than simply building cleanrooms. In fact, GMP standards to not specifically require cleanrooms. Having a production environment that is suitable for the cell-based therapy product in terms of environmental controls, ergonomics, and space sufficient for the staffing requirements of production is critical to successful manufacturing. Possible services may include:
- Developing design specifications for the intended facility, including environmental specifications and ergonomic requirements
- Design and writing of SOPs that drive the operation of the facility, insuring that the physical layout is utilized to optimize product and personnel safety and integrity
- Development of Validation Master Plans and Drug Master Files for the facility
- Facility commissioning and qualification plans
- Regulatory and Accreditation Compliance Gap Analysis
ANCILLARY FUNCTIONS
The best cell and gene therapy concept ever created is of no value if financial support cannot be secured to get the concept from the drawing board to early phase clinical trials to late phase trials to licensure and marketing. Similarly, in spite of the best and most honorable practices, legal disputes can sometimes crop up between parties in the cell and gene therapy field. Possible services may include:
- Due diligence reviews performed on behalf of investors
- Expert witness review, reporting to courts/arbitration panels, and testimony
