Production Facilities
New Production Facilities
Quotient is near completion in the design and construction of new highly cost effective and scalable fractionation facilities. These facilities are planned to house all of the functional operations required for plasma storage, blending, pooling, fractionation, and product vialing, to be certified to FDA's cGMP level.
A substantial commitment of millions of dollars in equipment and infrastructure has been made to meet all elements of our production process in detail. Each step of the production process has been defined in an effort to comply with the FDAs requirements under cGMP including traceability. In addition, members of our team have extensive experience in the construction, development and FDA validation and approval of FDA sterile ISO class 5/7 clean rooms and facilities for aseptic pharmaceutical product production.
Quotient is planning the new production facility to support its Phase 1/3 clinical trials which can produce millions of doses. The facility can readily meet the modest dose volume requirements of clinical trials and like all such facilities is being designed to minimize automation complexity and potential associated delays in equipment and system qualification. This facility is planned to initially support the FDA Phase 1 exemption from full cGMP requirements. Subsequently the facility is targeted to support full cGMP and Phase 3 clinical trial material.
Quotient is near completion in the design and construction of new highly cost effective and scalable fractionation facilities. These facilities are planned to house all of the functional operations required for plasma storage, blending, pooling, fractionation, and product vialing, to be certified to FDA's cGMP level.
A substantial commitment of millions of dollars in equipment and infrastructure has been made to meet all elements of our production process in detail. Each step of the production process has been defined in an effort to comply with the FDAs requirements under cGMP including traceability. In addition, members of our team have extensive experience in the construction, development and FDA validation and approval of FDA sterile ISO class 5/7 clean rooms and facilities for aseptic pharmaceutical product production.
Quotient is planning the new production facility to support its Phase 1/3 clinical trials which can produce millions of doses. The facility can readily meet the modest dose volume requirements of clinical trials and like all such facilities is being designed to minimize automation complexity and potential associated delays in equipment and system qualification. This facility is planned to initially support the FDA Phase 1 exemption from full cGMP requirements. Subsequently the facility is targeted to support full cGMP and Phase 3 clinical trial material.
Source Plasma Collection Centers
Quotient is currently collecting and continues to stockpile specific FDA plasma, and has enough inventory to support clinical trials, and upon FDA approval, start the launch commercial manufacturing efforts.
Quotient is currently collecting and continues to stockpile specific FDA plasma, and has enough inventory to support clinical trials, and upon FDA approval, start the launch commercial manufacturing efforts.