VDU: a one-stop-shop cGMP facility for small scale production of modified and derivatized Nanobodies

Nanobodies have emerged as excellent tool for therapy, non-invasive imaging and other types of diagnostics. Radiolabeled Nanobodies hold great promise to play an important role in development and implementation of personalized targeted treatment of malignant tumors while fluorescence molecular imaging is gaining significant interest from clinicians as an intra-operative guidance tool.

Radiolabeled and fluorescent labeled Nanobodies utilize either an unmodified Nanobody or, more usually, a chemically modified form. Labelling is either by direct attachment of a radionuclide or fluorochrome or attachment via a conjugating agent.
Though the production scale for Nanobodies intended for use with radiopharmaceuticals or fluorescent tracers is on a smaller scale than is usual in the pharmaceutical industry, the appropriate good manufacturing practice should be followed. This also implies that each relevant step in the production of the chemically modified Nanobody requires validation and quality control according to GMP standards.
Commercial C(D)MO's are very well equipped for the manufacturing of pharmaceuticals at large scale but do not offer production at small scale at an affordable cost.
The VDU at the VUB is bridging this gap by providing a "one-stop-shop" service from the design of the expression system up to the delivery of small scale GMP grade modified and derivatized Nanobodies to support small-scale toxicity and clinical studies.

Authors

Nick Devoogdt, Celine Coelis, Tony Lahoutte

Organisations

In Vivo Cellular and Molecular Imaging (ICMI) Laboratory, Vrije Universiteit Brussel (VUB), Brussels, Belgium.

Presenting author

Nick Devoogdt, Professor, Group Leader, Vrije Universiteit Brussel
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