Amsterdam Biotherapeutics Unit (AmBTU)

The Amsterdam Biotherapeutics Unit (AmBTU) is a spin off entity of the divisions of Immunology and Pharmacology of the Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital (NKI-AvL) and focuses on process development and GMP manufacture of biopharmaceuticals for investigational clinical use. The AmBTU is located within the premises of the Pharmacy of the NKI-AvL which holds a manufacturing authorisation for the clinical manufacture of Advanced Therapy Medicinal Products (ATMPs) for investigational use, including cellular therapy products and plasmid DNA (pDNA).

Expertise: The AmBTU supports several ongoing cellular therapy clinical protocols (TIL, gene modified T lymphocytes) and pDNA vaccination studies. AmBTU is partner in two other FP7 projects (RAIDs and ATTACK).

Facilities: The AmBTU production facility consists of three fully equipped class A/B (GMP EU) cleanrooms for the GMP manufacture of biopharmaceuticals.

The role of the AmBTU in the TargetAMD consortium is to develop, produce, QC and release of GMP grade pilot and clinical grade nucleic acids. AmBTU assists in the application of the clinical protocol(s) by the consortium, as well as supports editing the IMPD. With its expertise AmBTU has the knowhow to transfer the quality criteria of the safety enhanced pFAR technology combined with Sleeping Beauty (SB100X) transposon-based system into clinical use by GMP production. AmBTU has very strong relations with the Netherlands Cancer Institute (Amsterdam), which has shown interest in using the combined technologies realized by TargetAMD for transposon based transfection of human T cells for Adoptive Cell Therapy.

AmBTU has established a GMP grade production process for manufacturing clinical grade plasmid DNA vaccines. This process has been used to 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.).

The AmBTU holds a GMP manufacturing license for the production of cellular therapeutics and pDNA from the Dutch Ministry of Health. In addition, AmBTU holds the environmental license from the Dutch Ministry of Environment to produce and use clinically the DNA vaccines pDERMATT and MART-1 TCR transduced T cells.