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Our state-of-the-art plant is cGMP-certified and has been licensed by the Belgium Regulatory Agency for the manufacturing of ATMP products. The 1200m2 space is set up to manage multiple production and development projects simultaneously. Designed with agility in mind, it offers the possibility to rapidly double the available surface for additional GMP production capacity in just a few months.
To offer full flexibility, our facility currently has two identical units, divided into two production suites (large and small scale). Each unit allows for 100-120 runs per year (based on average process duration of three weeks and t-flask culture systems). Our facilities are fully equipped with the best of cell culture technologies, including; CliniMACS systems, single-use bioreactors of different sizes and from various suppliers*, bags, flasks and multiple stack devices, continuous centrifugation systems, automated cell counters, Sepax, MSC, CO2 incubators, fridges and freezers, microscopes, centrifuges (bags and tubes), plasma extractors, scales, CRF and more. We use dry plant and disposable single-use systems to avoid cross contamination, shorten set-up times and avoid the need for cleaning validation.
* Current bioreactors in our facility include: Wave (GE Healthcare), Quantum hollow-fibre cell expansion system (Terumo), iCELLis fixed-bed bioreactor (Pall Lifesciences), stirred tanks with microcarriers), and more.
Our laboratories include a fully equipped GMP-Accredited QC suite to support our customers' needs. It is made of three zones used for qPCR that are completely segregated. Each zone is fully equipped to perform optimal analytical methods that will ensure identity, stability, purity, safety and potency of our customers' cells. The biochemistry lab is equipped with a FACS Verse Flow Cytometer (BD), a molecular device microplate reader 190-850nm, a 7500FAST qPCR (Applied Biosystems), which enables testing of identity and purity of the products. The cell culture lab enables release testings, such as biological tests (numeration and viability, in vitro potency...) using inverted and fluorescence microscopes, laminar air flow, CO2 incubator, and qPCR to detect the presence of potential contaminants. The microbiology lab supports test environments through total aerobic bacterial count combined with yeast and mold numeration. We have 20/25 and 30/35°C incubators (up to 700 L vol.) that can treat high sample volumes. A pass box allows a simple and safe transfer of samples from production to our QC labs.
With over 80m2 of available surface, our warehouse is set up to facilitate product/material reception and labelling (area divided in approved and denied materials), product/material storage and packing. In addition, the warehouse includes -80°C freezers for virus storage. A segregated floor includes technical facilities to monitor the zones (GMP specifications).
There is also 33m2 of isolated room for process development optimisation. The tech transfer lab plays a key role in every customer project. Its flexible configuration makes it easily adaptable to specific customer projects.