Mark Cuban Cost Plus Drug Company: Sterile saline and sterile water for injection Advanced Manufacturing platform

Background: To ensure a consistent supply of safe, affordable, sterile saline and sterile water for injection Mark Cuban Cost Plus Drug (MCCPDC) company is proposing to design and build an Advanced Manufacturing platform that can produce both products at the time and location of need. Critical product uses include but are not limited to wound cleansing, intravenous use for rehydration medication dilution, inhalation therapy and laboratory use. MCCPDC was founded with a belief that everyone has the right to safe, affordable drugs at the time of need. The company already produces sterile injectable drugs for commercial use and has a fully qualified cGMP facility with a WFI system. Due to the shared mission, and existing cGMP facility used to manufacture comparable products, MCCPDC is uniquely positioned to support this critical need for our military personnel. Proposed R&D Project: The first Phase 1 will demonstrate proof of concept production of drug substance sterile saline and sterile water using nonsterile source water made under Current Good Manufacturing Practice (CGMP) regulations using equipment that can be packaged in no more than 2 CONEX containers (20 ft wide, 40 ft long). To accomplish this goal MCCPDC intends to manufacture pilot batches in an existing MCCPDC cGMP facility using compendial incoming, and finished, specifications to ensure ANDA compliance. MCCPDC is currently manufacturing drug products for the US market in a cGMP space in batch sizes ranging from 3L to 50L. The facility already has met all state and local building requirements to operate as a pharmaceutical manufacturing building. This includes emissions, wastewater discharge, waste disposal and shipping and handling of all materials necessary. For phase 1 no new equipment purchases are anticipated. To complete Phase 1 MCCPDC will manufacturing the pilot batches of sterile WFI and sterile saline solution uses the proves FDA Process Validation approach to ensure compliance. For Phase 1 only stages 1 and 2 of the process validation lifecycles are required.  Stage 1 (Process Design): MCCPDC will complete the product specific research and development phase to ensure it meets cGMP requirements while for manufacturing the product. Stage 2 (Process Validation): After Stage 1 is complete MCCPDC will perform product and process specific validation to ensure it can reproduce consistent and reliable levels of quality per the QTPP. Upon completion of the Phase 2 process validation runs technical reports, and COAs, will be drafted per established MCCPDC procedures. In parallel to completing the tasks MCCPDC will also complete a feasibility analysis and procurement plan for Phase 2 to ensure the manufacturing process can be tech transferred into the mobile manufacturing platform which meets the stated project Phase III goals.