Innovation pharma
Development of
Innovative targeted drug delivery
Protein-vector delivery drug Afotid®.
The innovative drug for targeted delivery Afotid® for the treatment of oncology is a conjugate:
- Polymer nanoparticle with incorporated dactinomycin and
- Vector protein, recombinant human alpha-fetoprotein (rhAFP).
Development of technologies for the production of pharmaceutical substances and finished dosage forms was carried out by Skygrad specialists. The drug is currently at the clinical trial stage.
Polymer nanoparticles with incorporated dactinomycin
The synthesis technology uses high-purity Russian-made dactinomycin. The synthesis of PLGA nanoparticles with incorporated dactinomycin is carried out using a high-pressure homogenization system, also of domestic production.
Recombinant human alpha-fetoprotein (rhAFP)
Recombinant human alpha-fetoprotein is an analogue of native (serum) alpha-fetoprotein, and by analogy with native human alpha-fetoprotein has an affinity for the AFP receptor and undergoes receptor-mediated endocytosis.
The recombinant alpha-fetoprotein used for the production of Afotid® is produced using technology developed by Skygrad, using equipment of its own production.
Development of
Biotechnology
Production of recombinant human alpha-fetoprotein:
Alpha-fetoprotein is the main oncofetal protein of all mammals.
For industrial production of recombinant AFP, recombinant plasmid DNA containing the human AFP gene was synthesized.
Production of recombinant alpha-fetoprotein is automated and is carried out on Skygrad's own cultivation and purification equipment.
You can purchase recombinant human alpha-fetoprotein produced by Skygrad for scientific research and production needs (purity 90-98% by ELISA).
Technology
Equipment
Technology
The Pichia pastoris yeast producer strain developed by Skygrad synthesizes and secretes alpha-fetoprotein in soluble form, which has an activity similar to human serum AFP.
The optimal fermentation mode has been selected, and technologies for isolating and purifying AFP from culture fluid and purifying AFP have been developed.
Equipment
Skygrad has developed a specialized version of a fermentation system for controlled cultivation of rhAFP, as well as a technological cycle for isolating and purifying the target product from the culture fluid, including the use of several stages of tangential ultrafiltration, ion exchange and hydrophobic chromatographic purification.
Advantages of the Skygrad rHAFP production technology:
- No risk of virus contamination;
- Unlimited access to raw material sources;
- Resolving ethical issues related to the use of human tissues;
We provide services:
- Development of equipment for controlled cultivation of microorganisms (pilot-industrial fermenters, from 2 to 50 liters)
- Development of a producer strain and its cultivation conditions to order
- Contract cultivation and isolation of biotechnological substances
- Development (optimization) of cultivation conditions in fermenters
- Development of technologies for isolating the target component from the culture liquid (microfiltration, ultrafiltration, chromatographic preparative purification, etc.)
- Development of methods for process control and quality control of the finished product in the production of biotechnological substances
Advantages of the technological equipment "Skygrad":
- Automated control of cultivation conditions with the ability to program the necessary process parameters
- Flexibility in the selection of cultivation conditions
- A wide range of methods for isolation and purification
- Use of domestic high-quality components
- Own software, Russian-language interface
- Repairability, warranty service, training
Development and validation of
Analytical methods for pharmaceuticals
We provide the following services to pharmaceutical companies, laboratories, quality control departments, research organizations, chemical and petrochemical industry enterprises:
- Methodological support and consulting for employees of quality control departments and plant laboratories;
- Development of draft regulatory documentation for pharmaceutical companies;
- Conducting validation procedures in accordance with the requirements of the EAEU for the registration of medicines and with the requirements of the Federal Agency for Technical Regulation and Metrology (Rostechregulirovanie) for metrological certification of measurement methods;
- Development of specialized analytical approaches using chromatographic and spectral methods of analysis, including for the analysis of synthetic and biopolymers;
- Transfer of analytical methods;
- Consulting on the use of analytical tools;
- Conducting theoretical and practical classes as part of advanced training courses qualification "Quantitative methods of analysis. Theoretical foundations and practical application".
Development of technologies for
Contrast agents for MRI
Skygrad develops diagnostic products based on rare earth elements of its own production. Currently, the technology of gadolinium-containing products for MRI is being developed.
Material and technical base
A wide range of equipment is used to develop innovative drugs and control them, including rare tools for analyzing biopolymers, as well as substances that do not have chromophore functions, in particular, HPLC equipped with a low-temperature light scattering detector.
Basic tools:
- clean room, laminar boxes and other equipment for working in sterile conditions;
- fermenters for controlled cultivation;
- high-pressure homogenizer;
- micro- and ultra-filtration systems;
- general laboratory equipment (evaporators, high-speed centrifuge up to 50,000 g, freeze dryers, shakers, etc.);
- preparative flash chromatograph;
- high-performance liquid chromatography represented by two instruments with spectrophotometric detectors and a light scattering detector;
- ion chromatography system;
- gas chromatography with a static headspace injection device;
- gel permeation chromatography;
- inductively coupled plasma mass spectrometry;
- ELISA system (ELISA photometer);
- DNA amplifier;
- polyacrylamide gel electrophoresis instruments;
- optical microscope;
- particle size analyzer.
Pipeline
Skygrad's portfolio of pharmaceutical developments includes two drugs in the clinical trials stage and two molecules in the development stage.
