PhD defence G. Kanojia
|When:||Fr 15-06-2018 11:00 - 12:00|
Drying made easy
The thesis of Gaurav Kanojia shows the application of spray drying technology to two viral vaccines and an experimental bacterial vaccine. The research was extended to stabilize monoclonal antibodies as well. Drying with stabilizing excipients was able to maintain the activity of the biopharmaceuticals and shows the potential of such biopharmaceuticals to be used without refrigeration in a powder form.
Maintaining vaccines and therapeutic proteins stable outside the cold chain remains a challenging ordeal. Spray drying is a promising technique to tackle this problem by providing dry powder formulations, with improved thermostability. In addition, powder particles can be engineered by spray drying to desired requirements, allowing them to be used by various delivery methods and routes. In this thesis Kanojia investigated the applicability of the spray drying technique to various biopharmaceuticals, including three vaccines and one monoclonal antibody. The work focuses on aspects such as the composition of the formulation, process conditions and the preclinical efficacy of the produced powders, after applying them via a mucosal route of administration (administration via the lungs).
First, insights into the spray drying process control were gained by applying systematic optimization for producing stable powders containing an inactivated influenza vaccine. This knowledge was extended to develop an inactivated polio vaccine formulation by strategic excipient screening, minimizing the loss of vaccine upon spray drying and storage. This was followed by spray drying of an experimental pertussis vaccine with full retention of structural integrity and immunogenicity after pulmonary administration in mice inducing systemic and local immune response (comparable to vaccine that was not spray dried). Finally, in prospect of developing an oral dosage form of a therapeutic monoclonal antibody, Infliximab was stabilized by spray drying, retaining its activity for 4 weeks at 60°C, comparable with the traditional freeze dried product. Stable dried biopharmaceutical would facilitate transport outside cold chain thereby reducing economic burden to poor countries.
Promotores Prof.dr. H.W. Frijlink and Prof.dr. G.F. Kersten