Fully equipped for successful product and process development from bench to pilot scale, the R&D Centre represents the core of Gnosis activities, where biologically active products come to life and are scaled-up to be transferred to our cGMP manufacturing facilities.

The R&D Centre operates in 5 major areas:

 

> STRAIN SELECTION

In the context of commercial strain development for improved active compound production it is important to evaluate the efficiency and practicability of the procedures used.

Typical constraints are the novelty of the microorganism, time and manpower. Established and more novel techniques applied to strain improvement can be divided into the induction of beneficial alterations and the screen for and recognition of such altered "mutants".




We established our platform to address the critical element of selecting the most optimal microbial host for production of metabolites including:

• Escherichia coli
• Bacillus subtilis
• Saccharomyces cerevisiae

Gnosis in-depth knowledge of these host microorganisms guarantees short and predictable fermentation development timelines. For all organisms, detailed studies with respect to their needs for optimal fermentation conditions have resulted in standardized protocols, enabling reproducible process scale-up from 10 liter to 120,000 liter fermenter size.

> FERMENTATION

After an accurate selection and isolation of microbial strains, fermentation processes are designed, using different scale fermenters, resulting in reproducibility and reliability once the process is scaled up to commercial manufacturing enhancing the quality of bioingredients produced.




> DOWNSTREAM PROCESSING

The active compounds that are produced by a microorganism during fermentation can be contained inside the cell or be transferred outside the cell in the fermentation media. The downstream processing is focused on the identification and design of purification methodologies in order to obtain active ingredients derived from fermented biomasses.

Solid-liquid separation is carried out using several different techniques such as centrifugation or flow filtration systems.




> SYNTHESIS

The synthesis unit is responsible for the definition and evaluation of innovative synthetic roots applied to modify the structure of natural metabolites obtained by the purification of biomasses and to obtain new chemical entities.





Researchers are also involved in the manufacturing of lab or pilot scale product samples for pharmacological or toxicological trials with the specific aim to characterize the potential impurities that can derive from each process.

> ANALYTICAL DEVELOPMENT

Analytical Development provides the definition and the validation of analytical procedures developed in house as well as the application of validated methods for in process controls for the complete characterization of finished products.





The analytical team of scientists employs the latest analysis methods for to provide high quality support in every phase of the development of new active ingredients; HPLCs, GCs and LC/MS are the most common analytical techniques but also protein analysis (SDS PAGE) and capillary electroforesis are also available. NMR is frequently used for the characterisation of the finished product.

Over 20 Researchers and Scientists with PhD in industrial Microbiology, Chemistry and Chemical Synthesis are responsible for protecting Gnosis intellectual properties of new products as well as production methods and processes by means of a patent application and trademarks registration.

Gnosis R&D is proud of its past successes, and is committed to improve the existing products and explore innovative areas.

 

GNOSIS S.P.A. Sede Legale: Piazza del Carmine, 4 20121 Milano. P. IVA 02484720129 C. F. 10197170151 Cap. Soc. 3.000.000,00 € i.v. Registro delle imprese di Milano N° 10197170151