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Biotherapeutic Unit

Products

 

TIL:

Tumor Infiltrating Lymphocytes (TIL), isolated and expanded from fresh tumor material can be a potent immunotherapeutic treatment option for metastatic melanoma patients. This treatment, developed at the National Cancer Institute, Bethesda, MD, is now used in several centers in the US, Europe and Israel. Our team has implemented the so-called "young TIL" process in the BTU facility.
The BTU is producing TIL products for an European multi-center phase III trial with TIL therapy which started in 2014.

TCR:

Infusion of patient T cells that have been genetically modified with tumor-reactive T cell receptors (TCR), so called TCR gene therapy, is an appealing immunotherapeutic strategy. TCR gene therapy can be used when tumor material is not available for the isolation of tumor-reactive T cells or in case tumor-reactive T cells cannot be expanded from such material.
In addition, TCR gene therapy allows the use of a set of particularly effective TCR genes in large patient groups. Furthermore, TCR gene therapy has the potential to treat patients with T cell populations that have an increased capacity for long-term engraftment, relative to the highly differentiated cell populations that are generally found within TIL.
The BTU has designed and validated a process to retrovirally transduce autologous T cells with a tumor specific TCR. This process is now used to produce cell products for a phase I/II trial in metastatic melanoma patients, conducted at the NKI-AVL in Amsterdam.

Plasmid DNA:

Circular plasmid DNA, produced and isolated from Escherichia Coli, has several appealing clinical applications. The BTU is able to produce GMP grade plasmid DNA that can be used in clinical trials.
Several DNA products that have been produced by the BTU have been used for a DNA vaccination trials at the NKI-AVL.
Besides DNA vaccination, plasmid DNA can also be used to genetically modify target cells as an alternative for expensive and laborious viral vectors.

New products

In collaboration with NKI-AVL scientist, medical doctors and other collaborators, we are constantly exploring new treatment options. Together with the NKI-AVL and NEON Therapeutics (Cambridge, MA) we are currently developing a neo-antigen directed T cell product. This will hopefully result in a new generation of personalized T cell therapy.

Publications


van den Berg JH, Gomez-Eerland R, van de Wiel B, Hulshoff L, van den Broek D, Bins A, Tan HL, Harper JV, Hassan NJ, Jakobsen BK, Jorritsma A, Blank CU, Schumacher TN, Haanen JB. Case Report of a Fatal Serious Adverse Event Upon Administration of T Cells Transduced With a MART-1-specific T-cell Receptor. Mol Ther. 2015 Sep;23(9):1541-50.

Gomez-Eerland R, Nuijen B, Heemskerk B, van Rooij N, van den Berg JH, Beijnen JH, Uckert W, Kvistborg P, Schumacher TN, Haanen JB, Jorritsma A. Manufacture of gene-modified human T-cells with a memory stem/central memory phenotype. Hum Gene Ther Methods. 2014 Oct;25(5):277-87.

van der Heijden I, Gomez-Eerland R, van den Berg JH, Oosterhuis K, Schumacher TN, Haanen JB, Beijnen JH, Nuijen B. Transposon leads to contamination of clinical pDNA vaccine. Vaccine. 2013 Jul 11;31(32):3274-80.

van der Heijden I, Beijnen JH, Nuijen B. Long term stability of lyophilized plasmid DNA pDERMATT. Int J Pharm. 2013 Sep 10;453(2):648-50.

Oosterhuis K, Aleyd E, Vrijland K, Schumacher TN, Haanen JB. Rational design of DNA vaccines for the induction of human papillomavirus type 16 E6- and E7-specific cytotoxic T-cell responses. Hum Gene Ther. 2012 Dec;23(12):1301-12

Henken FE, Oosterhuis K, Öhlschläger P, Bosch L, Hooijberg E, Haanen JB, Steenbergen RD. Preclinical safety evaluation of DNA vaccines encoding modified HPV16 E6 and E7. Vaccine. 2012 Jun 13;30(28):4259-66.

van den Berg JH, Oosterhuis K, Hennink WE, Storm G, van der Aa LJ, Engbersen JF, Haanen JB, Beijnen JH, Schumacher TN, Nuijen B. Shielding the cationic charge of nanoparticle-formulated dermal DNA vaccines is essential for antigen expression and immunogenicity.
J Control Release. 2010 Jan 25;141(2):234-40.

van den Berg JH, Nujien B, Beijnen JH, Vincent A, van Tinteren H, Kluge J, Woerdeman LA, Hennink WE, Storm G, Schumacher TN, Haanen JB. Optimization of intradermal vaccination by DNA tattooing in human skin. Hum Gene Ther. 2009 Mar;20(3):181-9. 

Quaak SG, van den Berg JH, Toebes M, Schumacher TN, Haanen JB, Beijnen JH, Nuijen B. GMP production of pDERMATT for vaccination against melanoma in a phase I clinical trial. Eur J Pharm Biopharm. 2008 Oct;70(2):429-38.

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Joost van den Berg

Head of facility - Pharmacist

Experience

I was trained as a pharmacist and developed a special interest in immunotherapy during my PhD project at the NKI/ Slotervaart Hospital/ Utrecht University and subsequent postdoctoral training at the Center for Cancer Immune Therapy (CCIT) in Copenhagen, Denmark.

Currently, I am responsible for the development and production of immunotherapeutic products in the in-house GMP facility of the NKI/Slotervaart Hospital. In addition, I am involved in the execution of immunotherapy trials, including DNA vaccine trial, and adoptive cell therapy trials with gene modified peripheral blood T cells and Tumor-Infiltrating Lymphocytes.

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Nijenhuis

Dr. Cynthia Nijenhuis

Pharmacist

Experience

I was trained as a pharmacist (PharmD) at the University of Groningen, during which I did research internships at Cornell University and the University of Groningen on analytical techniques for oncology diagnostics (microfluidics). After university I  did my PhD training at the NKI/Slotervaart Hospital/Utrecht University, which focused on bioanalysis and clinical pharmacology of new anticancer agents. The (clinical) development of anti-cancer (bio)therapeutics has my interest, with a focus on drug analysis and characterization (e.g. ADME studies, QC and bioanalytical analysis, drug product quality).

Currently I work on the development and production of immunotherapeutic products in the in-house GMP facility.

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Maaike van Zon, BSc

Technician

Experience

I am active as a technician in the group of Ton Schumacher to help develop clinical trials of TCR gene therapy. In this process, T cells are genetically engineered to target tumor antigens.

My work involves both research (optimization of protocols) and the generation of cell products for clinical use, and the fact that my work brings research and clinical work together makes it really interesting and exciting.

Before joining the Schumacher lab, I worked as a technician in the electron microscopy group, where I performed research on the localization of different mycobacteria. Here I also performed my internship to obtain my bachelor's degree.

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Noor Bakker

Ph.D. Student

Experience

I studied Biomolecular Sciences at the VU Amsterdam. After obtaining my master's degree, I worked for 5 years as a technician in the GMP therapeutic production facility of the NKI were we produced e.g. TILs. In addition, I was involved in several translational research projects in collaboration with the groups of Ton Schumacher and John Haanen, and responsible for the immunomonitoring of a phase I/II clinical vaccination trial.

I am currently a PhD student in the lab of Karin de Visser, in close collaboration with Marleen Kok. My research project is focused on assessing the influence of tumor subtype, tumor stage and (immuno)therapy response on the intratumoral and systemic immune landscape of breast cancer patients.

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Experience

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Experience

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Colak

Merve Colak

QA Officer

Experience

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Nuijen

Bastiaan Nuijen

Founder BTU and Head of Production

Experience

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Jos Beijnen

Founder BTU & Qualified Person

Experience

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Ton Schumacher

Founder BTU & group leader

Experience

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John Haanen

Founder BTU & group leader

Experience

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