Vaccine manufacturing under cGMP conditions require a complex series of steps to ensure that the final product is ready to be delivered to the selected clinical sites, where it will be administered to patients in clinical trials. Because the product will be used in humans, it is critical to ensure there are no contaminants and that the purity level of the vaccine is the highest possible.
At Advent, our major strengths in vaccine manufacturing can be listed as follows:
- Producing, sub-culturing and characterizing Master Cell Banks (mammalian cell cultures both in adherent and suspension culture conditions by using different size, single-use cell bioreactors; these cell bioreactors use only sterile disposable bags/containers);
- Performing MCB infection by the use of pre-GMP seeds (adenoviral seeds are produced and characterized in our Process Development laboratories using cGMP-grade materials);
- Harvesting and rescuing adenovirus from infected cells (adenovirus vector particles are rescued, concentrated and formulated through Tangential Flow Filtration disposable technology. This is a filtration system capable of cutting off undesirable particles of defined size, and at the same time to concentrate the product or to exchange the process buffer as requested by the production step);
- Performing adenovirus purification from contaminants (Anion Exchange Chromatography AKTA system in different process scale/size, a system capable of reducing the values of contaminants such Host Cell proteins and Host Cell DNA to undetectable levels);
- Fill and finish of drug product (formulated vaccines filled in aseptic conditions into containers suitable for clinical trials).
To ensure the highest quality of product, Advent deploys a number of strategies, from the plant and facility design to the selection of the appropriate equipment, maintenance and re-validation plans, and the accurate selection of raw materials. Moreover, Advent maintains a continuous improvement policy to better comply with current regulatory guidance on products and operations. This policy includes constant personnel training and qualification on dedicated SOPs.