Manufacturing

Manufacturing scale-up is a major focus in order to meet projected commercial demands and reduce costs for supply.  

We have developed manufacturing processes employing two dimensional (2D) technology, and have made significant advances in the development of three dimensional (3D) bioreactor technology.  Our manufacturing activities have met stringent criteria set by international regulatory agencies.

Our MLC–based product manufacturing and distribution process generally involves five major steps:

  1. Acquire bone marrow from healthy adults with specific regulatory defined criteria, which is accompanied by significant laboratory testing to establish the usability of the donated tissues.

  2. Create master cell banks by isolating MLCs from the donated bone marrow and performing a preliminary expansion to create master cell banks. Each individual master cell bank comes from a single donor.

  3. Expand to therapeutic quantities by growing cells in the master banks to produce therapeutic quantities. This process that can yield thousands of doses per master cell bank, with the ultimate number depending on the dose for the respective product candidate being produced.

  4. Formulate, package and cryopreserve

  5. Distribution With the exception of procurement and creation of master cell banks, our manufacturing is conducted by Lonza in its Singapore facility then shipped to distribution or treatment centers.

 Manufacturing Graphic