General Information on R&D
The workshop for the pilot production is designed and built in compliance with Chinese GMP 2010. The sterile workshop is about 1000m2, including preparation area, biological positive area, purification area, vaccine formulation area and sub-packaging and lyophilizing area to realize the production functions such as: preparation of bacteria spawn, cell and toxin, cell cultivation, bacterial fermentation, primary purification, refined purification, sub-packaging and lyophilizing.
In different areas of the pilot production workshop there are independent HVAC system, purified water system, purified steam system, water for injection preparation system, CIP system, cold medium system, wasted water dealing system, material temporary storage, cold warehouse etc. The workshop has passed the Biosafety Class II Laboratory Accreditation.
In the pilot production workshop, there are fermentation tank of 50L, 100L, and 500L, various kinds of centrifuge, ultra-filtration systems of differents pecifications, GE protein separation and purification system, sub-packaging and lyophilizer etc. Thus the process research of virus vaccine, bacterial vaccine, conjugate vaccine and gene-engineered vaccines can be done.
Research and innovation is the vital force of an enterprise. Guided by the bi-wheel strategy of “researching novel vaccine, upgrading traditional vaccine”, Olymvax adopts the “dependent research and cooperating research” as R&D model. Through years’ hard working, Olymvax has formed a stair-like product development type, that is, with a rich products’ follow-up reservation, the first traditional vaccine product is about to launch on the market; several innovative vaccines and upgrading vaccines are in the process of good development. By now, olymvax has 10 products, which are respectively in the different stages of pre-clinical study, clinical trial registration, clinical trial and production registration.