Interferon-ß as a biological for treatment of multiple sclerosis and Hepatitis-B-Antigen as a vaccine have in common, that the application is currently done by injections, which are having some disadvantages. Injections are e.g., painful, are often creating infections and reactions at the injection, are causing side-effects due to the use of stabilizer and adjuvants. Additionally, the Interferon-ß and Hepatitis-B Surface Antigen are not-thermostable and will need to be stored in the refrigerator, which restricts the flexibility in use. All those disadvantages in the current state-of-the-art therapy are resulting in a poor-patient compliance associated with additional costs for the health-care-system.
The application of Interferon-ß and Hepatitis-B-Antigen via dissolvable Micro-Array-Patches (MAP) Technology is addressing the above mentioned unmet medical needs. The MAPs allow the painless self-administration. Due to the embedding of Interferon-ß and Hepatitis-B-Antigen in a polymer-matrix the stability of the Interferon-ß and Hepatitis-B-Antigen can be improved. Those improvements provided by the MAP administration are resulting in a better patient compliance.
The webinar will provide an insight in the development of a Interferon-ß containing MAP and the critical quality attributes (CQA) to be considered and met during development. Additionally, establishment of a GMP manufacturing process for the performance of a pre-clinical study is discussed. Pre-clinical data for 2 prototypes will be presented and discussed. For the Hepatitis-B-Antigen preliminary read-outs from a clinical phase I study will be provided showing the induction of stronger immune-response in comparison to classical vaccination by injection, which is offering the opportunity for dose sparing.
The webinar will demonstrate that the technology of dissolvable MAPs in addressing unmet medical needs for life-time treatment with biologicals as well as vaccination.
Key Learning Objectives
- Why select dissolving microneedles
- How to manufacture Micro Array Patches
- Why the dissolvable microneedle technology is an ideal candidate for biologics and vaccines
- Insights in Critical Quality Attributes for Micro Array Patches containing biologics and vaccines
- Case study biologics: Micro Array Patch containing Interferon-Beta
- Case study vaccines: Micro Array Patch containing Hepatitis-B Surface Antigen
