Services

Proteins production from mammalian cells 

Upstream and Downstream processes for protein production from mammalian cells (CHO). Processes  Scale-up to pilot  and  industrial scale.  Optimisation to increase both step and total yields and optimise process costs. Implementation of analytical methods, both chromatographic and enzyme immunoassay for process monitoring. Support to QA departments for process and implant validation.  Support for patents and scientific reports drafting. Process cost evaluation.

Proteins production from Bacteria 

Upstream and Downstream processes for protein production from Bacteria. Extraction and purification from both culture broth and included bodies by folding-refolding. Enzyme reactions and immobilisation on suitable media. Mutants preparation and analytical evaluation. Processes scale-up to pilot  and  industrial scale.  Optimisation to increase both step and total yields and optimise process costs.  Support to QA departments for process and plant validation. Support for patents and scientific reports drafting. Process cost evaluation.

Proteins production from plants (Plant Molecular Farming) 

Upstream and Downstream processes for protein production from tobacco's leaves and rice. Extraction with homogenisers and blade mills, Clarification with depth filtration and cross flow filtration. Intermediate, final purification process and formulation using various chromatographic techniques. Processes scale-up to pilot  and  industrial scale. Chromatographic and enzymatic analytical methods. Evaluation of endotoxin content, protein glycosylation, final purity. Support for patents and scientific reports drafting. Process cost evaluation.

Analytical methods development

Implementation of analytical methods for process monitoring and product characterisation. During the study of a downstream process, need analytical methods to control the protein purity and both  step and processes yields. To achieve the objective, it is essential to use any analytical methods capable of providing the required informations. There are several methods that can be used such as SEC chromatography, Rp, Affinity, Ion Exchange etc, but also Elisa, Blot, Electrophoresis and other techniques that provide important information on product quality after a step or at the end of the process such as Endotoxins content, Host cell proteins, DNA, Glycan profile, peptide mapping etc. 

Downstream scale-up (Lab scale-Pilot scale- Industrial scale)

After developing  downstream process to lab scale, need  move to pilot scale, for pre-clinical studies batches  preparation, and eventually to industrial scale. Instrumentations, such as extraction systems, ultracentrifuges, chromatographs, filtration systems, tangential flow filtration systems (micro and ultrafiltration) and a variety of materials are involved in those process. The correct selection of tools and materials has a major impact on the process, and in-depth knowledge acquired over time about execution of many protein production processes is required.

Validation process and implants support

Support to QA departments for process and implant validation. At the end of the study phase of a recombinant protein production process, whether preparing batches for pre-clinical studies or for production, validation of instruments, methods and the entire process is required. The preparation of a Validation Master Plan and the operational procedures, logbooks, and instrument maintenance is a key point. Operations such as washing, sanitising and preservation of instruments, chromatography columns, filtration systems, etc. must also be validated with in-depth chemical-bacteriological analyses.