Human Phase I Cell-based Products GMP Facility
This ISO 7 cleanroom facility has been developed to focus on production of human cell-based therapies under controls consistent with US FDA current Good Manufacturing Practices (cGMP) for use in Phase I, first in human, clinical trials in accordance with the written Investigational New Drug (IND) protocol controlling the work.
Why we are the best choice
- We work with your technical experts.
- This drastically reduces costs and allows you to ensure that the protocol is being implemented by an expert.
- Our charges are based on a low daily use fee and time inside the facility.
- We are a one-stop shop.
- We can help you from starting and preparing your IND application, to generating the GMP-compliant Phase I material.
- We have an extensive scientific network that can help you optimize your protocol, design improved manufacturing solutions, and address scale up issues.
- Training client employees working in the facility on proper cGMP
- Converting client documents into a cGMP compliant format (CBCM Facility template)
- Supervising and providing assistance for manufacturing and to ensure cGMPs are followed
- Conducting initial Quality Assurance (QA) reviews in-house, and getting an independent external final QA review
- Investigating protocol deviations and writing Corrective Action Preventive Action (CAPA) plans and risk assessments.
- cGMP-compliant maintenance of all original documentation
- Providing consultation related to GLP and GMP practices coupled to Phase 1 trials
Jay Xie, Facility Manager
Office Phone: 919-515-8085