We pride ourselves in being a global leader in the development of vaccine & viral vector formulations —whether liquid, lyophilized or spray-dried—for a large variety of ATMP and vaccine types. Our database and algorithms, together with our expertise, help to make the impossible possible and provide tailored and best-in-class formulations for your specific vaccine / virus. Some of our examples in the field of ATMPs and vaccines are shown below.
- Poxviridae (e.g. modified vaccinia virus Ankara (MVA)
- Adeno-associated virus (AAV)
- Adenovirus (Ad)
- Paramyxovirus strains
- Influenza strains
- MVA as vector
Case Study – 1 - Liquid
Best-in-class formulations for Ad5 viruses and viral vectors
Internal R&D project implementing an excipient preselection approach, enabling rational formulation development and the generation of best-in-class formulations for Ad5 viruses and viral vectors in liquid.
Case Study – 2 - Lyophilized
Stabilization of human adenovirus (ATMP)
Customer project (oncology) to stabilize human adenovirus in lyophilized form: Leukocare successfully stabilized an adenovirus with undisclosed insert during lyophilization and storage for at least 24 months. After lyophilization titer drop was < 0.3 log; total titer drop during lyophilization and storage was < 0.4 log.
Case Study - 3 - Influenza vaccine
Development of an influenza vaccine as dry powder
R&D collaboration with Christian-Albrechts-University (Kiel, Germany): Development of an influenza vaccine as dry powder to increase stability, enable terminal sterilization, and to utilize alternative routes of administration.
Immune response in non-human primates was fully retained after spray-drying and irradiation with Leukocare formulation compared to non-irradiated original Pandemrix®.
Storage at ambient conditions (25°C and 60% relative humidity) did not show an influence on the antigen integrity and activity.
Immune response in macaques to Pandemrix vaccine (HAI titer), PBS=negative control. *significantly different (p < 0.01) from group 2, 4 and 5 mean titers of groups 2,
4 and 5 were not significantly different from one another (bars represent the geometric mean titer for each group).