Fast Trak China has developed a new acellular pertussis vaccine process, which increases the yield and purity from 10% to 30% and 85% to 95%, respectively. During process development, we successfully added one more antigen to create a trivalent vaccine. In vaccine production, the quantitation of virus concentration and host cell protein (HCP) impurities is critical for the final formulation. We used surface plasmon resonance (SPR) biosensor technology on GE Healthcare’s Biacore platforms to determine vaccine concentrations with higher sensitivity, less hands-on time, and higher precision than SRID and other commonly used methods such as ELISA. In the future, this new quantitative assay may well be the reference standard at The State Food and Drug Administration (SFDA) of China. The IP behind this novel process has been published at www.IP.com. We provide the IP free of charge and in addition to the two customers who are implementing this novel method under MTAs, two others are using it under the guidance of FastTrak China as consultants.
Traditionally, the production of meningococcal A, C, W, Y vaccine has involved the use of phenol to rid the sample of protein material. Since the use of phenol is no longer acceptable, we developed a modern technique based on Capto chromatography media (resins). The new process is easy to scale up and it works in a simple flow-through mode for all four serotypes. The level of protein/DNA/endotoxin levels in the final product meet the standards required by regulatory authorities and the absence of phenol is good for both the environment and process plant operators.
The success of these two projects has allowed GE Healthcare to apply these novel methods to the development of other vaccines. Whether you are a novice or an experienced researcher, this webinar will be a valuable source of innovative ideas and solutions so please join us.
Before joining GE, Dr Tian worked as a protein chemist at the China Research Center of Genencor, which is the second largest industrial enzymes producer in the world. As a line manager, she was responsible for protein purification and fermentation platforms. By purifying more than 120 enzymes from bacterial or fungal hosts, she got abundant experience in protein purification, quantification, characterization, and fermentation.Before her Ph.D. study, she worked in a biotechnology company (Shanghai Genon Biotechnology Co.) as a scientist. Based on the transgenetic mammary gland bioreactor platform, she designed the purification processes for rhEPO and rhLF from transgenetic goat milk and also purified functional proteins from animal tissues and plasma.