OUR MISSION
At VDU, we act with enthusiasm to bridge the gap between fundamental research and clinical application. We enable small-scale cGMP-compliant production of biologics, with a strong focus on single domain antibodies (sdAbs), empowering academic and research institutions or industrial partners with accessible, high-quality development and manufacturing services that meet stringent regulatory standards.
Driven by clear intention to manufacture Active Pharmaceutical Ingredients (APIs), we support the translation of scientific discoveries into safe, effective, and regulatory-compliant investigational medicinal products (IMPs) for Phase I/II clinical trials. Through a multidisciplinary Quality by Design-approach, we uphold rigorous quality standards, foster innovation, and contribute to the advancement of healthcare via strategic project management and continuous improvement.
We build connections across disciplines, creating a collaborative environment where science, compliance, and purpose align. We believe that this unique approach within the research setting of the Vrije Universiteit Brussel and the Molecular Imaging and Therapy Research group enables the transition from bench to bedside, from initial R&D phase to clinical validation.
What is cGMP and why is it necessary?
Current Good Manufacturing Practice or cGMP is a system of regulations and procedures that ensures medicines and biologically derived products are produced consistently, safely, and with controlled quality. GMP covers every aspect of manufacturing, including facilities, equipment, personnel training, documentation, raw materials, and product testing. Its primary goal is to minimize risks such as contamination, mix-ups, and errors during production, ensuring that every batch meets predefined quality and safety standards.
For products intended for clinical trials or patient use, regulatory agencies require that they are produced under GMP conditions. This ensures that the product’s identity, purity, and potency are documented and reproducible, providing confidence for regulators, clinicians, and patients.
At VDU, we aspire to:
- Advance translational research through end-to-end support from formulation to early phase clinical trial material production
- Set new standards in academic GMP manufacturing by applying ICH guidelines, Quality by Design principles, and Quality Risk Management.
- Cultivate a quality-driven culture within academia that embraces audit-readiness, regulatory compliance, and continuous learning.
- Support the growing biologics market by developing expertise in the production, safety, and analytics of sdAbs and other biopharmaceuticals.
- Receive GMP certification for API manufacturing through ongoing excellence and strategic alignment with regulatory authorities such as the FAGG.
THE GMP PRODUCTION WORKFLOW
The first step towards a cGMP production is the production of a Research Cell Bank (RCB) and subsequent production of a Master Cell Bank (MCB) comprising Komagotaella phaffii or Pichia pastoris cells containing the gene encoding the protein of interest in its genome. The RCB is fully characterized before it is used to produce the MCB. Quality Control (QC) of the MCB consists of prespecified release tests.
Before the production of a cGMP batch, several technical batches are produced, where production and QC methods are optimised and upscaling made possible. After this, an engineering batch is produced, serving as a reference GLP batch which can be used for toxicity studies. The engineering batch and cGMP batch follow the same plan:
This production plan comprises the upstream (USP) and downstream (DSP) bioprocesses, where USP is the development of cell culture and DSP is the purification step.
Upstream processing
From a MCB, a preculture is made and transferred aseptically to a 30 L bioreactor or Single Use Fermenter (SUF) for batch cultivation. Biomass increases, the culture enters the batch phase followed by the fedbatch phase and finally reaches the induction phase, where methanol is added to activate the promotor.
The gene of interest is constructed, ensuring high levels of transcription and the Active Pharmaceutical Ingredient is then recovered from the supernatant.
Downstream processing
DSP consists of a single- or multi-step purification via for example ion exchange chromatography and thereafter tangential flow filtration, concentrating and buffer exchanging the sample solution, ensuring a high yield of stable protein in the final formulation buffer.
Quality Control
Quality Assurance
Batch release
