DEVELOPMENT
With a leadership position in cell biology, virology and molecular biology, and in strict compliance with current legislation regulating the production of patient-specific cells, genetically modified cells and viral vectors for clinical use, we provide our customers with a full range of services. Our excellent drug development scientists, technicians and project leaders can provide a unique expertise to reach the goal you expect from your projects. They will work closely with you to identify appropriate raw materials, media etc. and to design scalable, repeatable and cost-efficient processes suitable for transfer in GMP.
During the development phase, manufacturing and analytical methods are developed and optimised to produce large-scale target biologics and evaluate their potency and other essential characteristic. The methods are designed and the specifications established in order to comply with current regulations for biotechnology products and advanced therapy medicinal products.
In our development laboratories, high quality pre-GMP materials can also be produced at small or large scale, sterile and with low endotoxin content, ready for use in research, development and preclinical studies.
FEASIBILITY STUDIES
PROCESS DEVELOPMENT & SCALE-UP
• Selection of raw materials and production systems / purification / handling applications suitable for GMP.
• Preparation of stable cell clones specific for the production of retroviral vectors.
• Cloning of hybridomas or other cell lines.
• Optimization of culture conditions and cell adaptation to serum-free conditions.
• Development and scale-up production processes for retroviral and lentiviral vectors (flasks, cell factories, bioreactor), antibodies, recombinant proteins from mammalian cells.
• Development and scale-up of purification processes (chromatography, filtration hollow fiber, ...) of retroviral and lentiviral vectors, antibodies, recombinant proteins from mammalian cells.
• Development and scale-up of filtration and filling.
• Selection, purification or depletion of cell populations from primary cultures.
• Optimization of culture and transduction conditions of primary cells.
DEVELOPMENT OF ANALYTICAL METHODS
• Cell assays, such as cell vitality, proliferation, toxicity, apoptosis, cell cycle, ...
• Immunoassays: ELISA, flow cytometry, ...
• Microbiology: sterility, mycoplasma, endotoxin for specific applications.
• Virology assays: RCR, RCL, viral titer determination for specific applications.
• Molecular biology: PCR, RT-PCR, PCR, quantitative, Northern Blot, Southern Blot, ...
• Stock cell lines.
• Retroviral and lentiviral vectors.
• Stock primary cells.
• Primary cells genetically modified.
• Monoclonal antibodies.
• Recombinant proteins from mammalian cells.
