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.

  • Expertise: The AmBTU supports several ongoing cellular therapy clinical protocols (TIL, adoptive cell therapy) and pDNA vaccination studies.

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

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

We have developed new, improved vaccin formats for HPV E7/E6 DNA vaccines :

  • K. Oosterhuis et al. Int J Cancer 2011 Jul 15;129(2):397-406.

  • K. Oosterhuis et al. Hum Gen Ther 2012 Sep 12.

 

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

  • Prof Jos H Beijnen, PharmD, PhD: Qualified Person is registered hospital pharmacist and head of the AmBTU and the Division of Pharmacy and Pharmacology, Slotervaart Hospital/ The Netherlands Cancer Institute.

  • Bastiaan Nuijen, PharmD, PhD: Head of Development and Production is registered hospital pharmacist and head of production and development of the AmBTU and the Division of Pharmacy and Pharmacology, Slotervaart Hospital/ The Netherlands Cancer Institute.

  • Joost H. van den Berg, PharmD, PhD: Is a post-doc and pharmacists who has worked the past 7 years on the (pre-clinical) development and production of immunotherapeutic treatments against cancer.