Vaccine Development at CPI
The World’s population is facing increased threats of disease from pathogens. Whether it is an influenza pandemic or outbreak such as the recent Ebola crisis in Africa or diseases such as Malaria or Severe Acute Respiratory Syndrome (SARS), the need for cheaper, effective vaccines is on the rise. Thanks to advances in medicine, we can now use viruses to treat disease, and it’s this area of vaccine development where CPI can help.
We are working with companies to help treat disease through the development of innovative viral vectors and vaccines. We have a range of projects currently underway, a recent example is a collaboration with Cobra Biologics to develop an industrial manufacturing platform for adeno-associated virus (AAV) production. This project addressed the key barriers facing routine production of AAV by focusing on the development of a scalable platform process.
CPI is also a member of the Future Vaccine Manufacturing Hub. Led by Imperial College London, the research hub is aimed at delivering high-quality vaccines at low cost to prevent outbreaks of diseases such as Zika and Ebola.
CPI has the drive, knowledge and infrastructure to support the development, optimisation and scale-up in the vaccine field and our capabilities include:
- Creation of GMP compliant master and working cell banks along with viral seed stock that are free from mycoplasma and adventitious viruses.
- Media, seed train, product and titre optimisation using a design of experiment (DOE) approach, utilising our ambr15 and ambr250 automated bioreactor systems.
- Confirmation of optimisation and material generation through a variety of cell culture approaches, including rocker bag system (e.g. Sartorius RM rocker systems), 2L or 10L stirred tank bioreactors or adherent cell culture.
- Cell bank and virus purity, genetic stability and characterisation.
- Experience with development of adherent or suspension culture systems. Line of sight to scale up with in house capability to 4m2 (adherent) or 50L/200L (suspension).
- Process characterisation analytics, including titre assessments, potency, aggregation, infectivity, presence of adventitious agents and contaminants.
- Platform processes for harvesting and clarification involving depth filtration and TFF options.
- Purification platform development based on chromatography approaches (beaded and non-beaded media i.e. membrane, monolith, other) making use of our automated liquid handling systems and matched analytics (i.e. plate readers, Labchip, Gyrolab).
- Conjugation development experience and development of predictive models.
- Drug substance formulation development – liquid/frozen liquid and lyophilised. Indicative stability testing (using ICH stability conditions).
For more information on vaccine development at CPI or to speak to one of our experts please don’t hesitate to get in touch.