CG201 Manufacturing

CGT has established relationships with GMP (Good Manufacturing Practices) qualified contract manufacturers to produce CG201. CG201 is a well-characterized formulation made from components that have all been manufactured previously. Compared to most biotechnology products, CG201 is inexpensive to manufacture and does not require construction of costly manufacturing facilities. In contrast, monoclonal antibody therapies and “personalized” cancer vaccines can cost up to a thousand times more per dose to manufacture.

CG201 Components
CG201’s immunogens, CTP37-DT and LP20-DT, are constructed from chemically synthesized peptides that are attached to the diphtheria toxoid protein carrier molecule via chemical linkages. The manufacturing process is carried out in facilities that use highly controlled GMP procedures required by the FDA.

CTP37-DT Immunogen	LP20-DT Immunogen

Contract Manufacturing
CGT’s contract manufacturers have begun producing batches of components and complete vaccine on a timetable that supports all clinical trials contemplated at present. These suppliers are capable of scale-up and repeated manufacturing of individual lots of components and vaccine in timeframes much shorter than those required for most biotechnology products, because CG201 is relatively straightforward to produce.