Fully equipped for successful product and process development from bench to pilot scale, the R&D Centre is 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:
Isolation, development and maintenance of proprietary industrial strains.
During development of commercial strains to improve the production of active compounds, the efficiency and practicability of the followed procedures is an important factor. 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 ensures short and predictable times of fermentation development. For all organisms, exhaustive studies of their needs for optimal fermentation conditions have led to standardize protocols, enabling reproducible process scale-up from 10 liters to 120,000 liters fermenter size.
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, and enhancing the quality of the bio-ingredients produced.
The fermentation unit has 16 pilot fermenters with a capacity from 5 to 300 liters, with a centralised supervisory recording system for the definition of the most appropriate in-process controls and parameters.
The active compounds produced by a microorganism during fermentation can be contained inside the cell or be transferred outside the cell in fermentation media.
The downstream processing is focused on the identification and design of purification methodologies to extract the active ingredients derived from fermented biomasses. Solid-liquid separation is carried out using several different techniques such as centrifugation or flow filtration systems.
Purification by means of liquid phase chromatografic techniques are performed through dedicated chromatografic systems from bench to pilot scales.
Extraction of natural liposoluble products, further than traditional extractive technologies by means of chemical solvents, can be performed using CO2 in supercritical phase, while for the extraction in water phase we can operate with mechanical lisators.
The synthesis unit is responsible for defining and evaluating the innovative synthetic roots applied to modify the structure of the natural metabolites achieved through the purification of biomasses and to obtain new chemical entities.
Researchers are also involved in the production of laboratory or pilot scale product samples for pharmacological or toxicological trials with the specific purpose of characterizing the potential impurities that may result from each process.
Analytical Development provides the definition and the validation of the analytical procedures developed in-house, as well as the application of validated methods for in-process controls for the complete characterization of finished products, including impurities profile.
The team of scientists employs the latest analysis methods to provide high quality support in every stage 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 electrophoresis. NMR is frequently used to characterize the finished product.
Studies on the stability of the products are carried out as according to the ICH guidelines. Furthermore many of the analyses related to the evaluation of the efficacy and safety investigations of the products are performed.
Gnosis intellectual properties of new products, production methods and processes are duly protected through patent application and trademarks registration by over 20 researchers and scientists with PhDs in industrial microbiology, chemistry and chemical synthesis.