Pharm InnTech LLC provides the following services:
- Testing of medications quality according to Russia State Pharmacopoeia, EAEU Pharmacopoeia, USP, Ph. Eur., ND
- Development and validation of drug testing methods for inclusion in ND
- Peptide mapping
- Characterization of recombinant proteins by mass-spectrometry methods:
- sequence verification of protein or peptide with the help of high resolution UPLC-MS
- de novo protein sequencing
- genuine verification of biomolecules by determination of accurate mass for the whole protein or its subunits, peptides and oligonucleotides
- analysis of post-translation modifications for the whole proteins, peptides, protein subunits
- search and quantitative determination of single point mutations by peptide mapping
- quantitative analysis and characterization of glycans, glycoproteins, glycolipids and other biomolecules
- determination of monosaccharides and sialic acids content in glycoproteins
- analysis of protein forms with Ion Mobility mass-spectrometry: native protein mass-spectrometry, protein denaturation profile in gas phase by CID
- disulphide bridge mapping
- development of peptide mapping methods, all-peak characterization for quality control during sample production
- determination of protein amino acid composition
- Quality control for recombinant proteins with HPLC methods: determination of aggregates by gel filtration chromatography, analysis of proteoforms with ion exchange chromatography, impurity analysis with reversed phase HPLC, characterization and quantitative determination of glycans
- Determination of fragments and high molar mass impurities with the help of gel electrophoresis in reducing and non-reducing conditions (and their identification with high resolution LC/MS)
- Determination of subunit composition and purity with the help of gel electrophoresis in reducing and non-reducing conditions
- Isoelectrofocusing
- Free thiol groups assay by Ellman method
- Sialic acids assay with the help of spectrophotometric methods
- Protein assay with the help of spectrophotometric methods
- Analysis of recombinant proteins with differential scanning calorimetry: verification of secondary structure and determination of protein thermal transitions for stability assessment
- Analysis of recombinant proteins with Fourier transform infrared spectroscopy (FTIR): verification of secondary structure of recombinant proteins and determination of secondary structures (quantitative, in %) for stability assessment, lot-to-lot reproducibility of production
- Lipid profile analysis, glycolipids analysis
- Quantitative analysis of biological samples for pre-clinical trials by using LC/MS methods
- Analysis of synthesis products by using LC/MS methods
- Investigation of extractable and washable substances from disposable equipment. Identification and quantitative determination of unknown extractable substances with the help of high resolution LC/MS/MS and GC/MS
- Development and validation of bioanalytical methods for determination of medications and their metabolites in biological samples
- Application of bioanalytical methods for investigation of pharmacokinetics and bioequivalence of medications
- Calculation of pharmacokinetic parameters, analysis of variance (ANOVA)
- Study of dissolution kinetics of medications
- Study of drug stability
- Identification of impurities in medications
- Storage and transportation of medications for laboratory tests