Research and development
Biotika a.s. makes use of know-how and knowledge its experts in fermentation, downstream processing, analytical methods. Biotika a.s. solves own projects, which then implements into its own manufacturing program or co-operates with other international companies by the form of biotechnological toll manufacturing.
Biotika a.s. has own collection of microorganisms. They are stored in lyofilized form, in liquid nitrogen or in a freezer at -80°C.
The department of analytical chemistry uses modern analytical techniques to control the fermentation and the recovery process (HPLC, GC, isotachophoresis).
On the department of DSP are used different equipments and techniques e.g. pressure filters, membrane units, centrifuge separation, extraction, decolorization, adsorption columns, comprehensive chamber filter, spray drying, rotary vacuum drying, freeze dryers.
There are 34 employees on R&D department, thereof 16 with university degree.
Process development includes
- Strain Improvement
- Production Process Development
- Production Process Scale Up
- Technical conditions
- The selection and testing of the best isolates of the production strain
- Optimising of the media compositions
- Optimising of cultivation conditions in the lab-scale
- Optimising of the fermentation process in pilot scale (composition of inoculation and production media’s, inoculum cascade strategy
- Optimising of the cultivation conditions during the fermentation process (temperature, pressure, pH, aeration, agitation, dissolved oxygen control)
- Development of the analytical methods for the in- process control
- Strategy of the substrates feeding (source of N, C, P, organic nitrogen)
- Recovery process development in the pilot scale
- Recovery line proposal and designing
- Verification of the process in the pre-industrial & industrial scale and further optimisation of those scales
- Binding analytical methods of the in-process control and final product evaluation
- Description of the process in written form
- Drug Master File formulation
- Process improvement and costs reduction
- Evaluation of the variable costs of the process
- The newly built microbiology laboratories witch satisfy GMP, i.e. defined purity class C, D and class A under laminar boxes, fully steam automatic sterilizers and dry heat sterilizer
- Lab scale – shakers
- Pilot scale – 5 litres up to 75 litres fermenters
- Pre-industrial scale – 800 – 5000 litres fermenters
- Industrial scale 50 m3 or 150 m3 fermenters
- Whole range of standard analytical control
- Recovery line has to be designed base on the product