Amsterdam Biotherapeutics Unit
The Amsterdam Biotherapeutics Unit (AmBTU) is a spin out of the Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital (NKI/AvL) and the Slotervaart Hospital (Slz) and focuses on the process development and GMP manufacture of biopharmaceuticals for investigational clinical use. The AmBTU is located within the premises of the Slz which holds a manufacturing authorisation for the clinical manufacture of Advanced Therapy Medicinal Products (ATMPs) for investigational use, amongst which cellular therapy products and plasmid DNA (pDNA) vaccines.
The AmBTU established a GMP grade production process for the manufacturing of clinical grade plasmid DNA vaccines. This process has been used produce the melanoma vaccine pDERMATT that is currently used in the clinic (Quaak et al. Eur. J. Pharm & Biopharm 2008 Oct;70(2):429-38.)
We have developed new, improved vaccin formats for HPV E7/E6 DNA vaccines :
Role within the project
Contribution of the AmBTU to the RAIDs project will be the GMP production of HPV E7 and E6 pDNA vaccines for clinical trials.
Description of key people involved in the project