Bioanalytical services
Skylimit provides feasibility evaluation to sponsors based on different literature support before the execution of a trial. We at Skylimitare committed to providing detailed bioanalytical feasibility and bioanalytical testing services to understand and estimate the complexities involved during execution.Leveraging state-of-the-art instrumentation, techniques, and facilities, our team of experts has experience in a broad range of small and large molecule bioanalytical and biomarker support. Working in a good clinical laboratory practice (GCLP) compliant setting, the Skylimits Bioanalytical Laboratory provides method development, transfer, validation, and analysis of preclinical and clinical biological samples. We have extensive expertise in developing sensitive methods for LC-MS/MS – qualifying multiple-analytes, metabolites, prodrugs, and light- and temperature-sensitive compounds.
Skylimit offer the following Bioanalytical services :
- Bioanalytical method development/transfer/validation
- Chiral Assay
- Micro dosing levels detection and quantification
- Cocktail analysis
- Small Molecule biomarkers
- Biological Fluid Samples analysis
- Tissue Analysis
- Metabolite Identification & qualification estimates
- Endogenous substances
- Protein binding
- Drug-drug interaction studies
- Micro dosing levels detection and quantification
- Small peptide analysis
- NCE method development & validation
- Conjugate/non-conjugate levels estimate
- Light & temperature sensitive (Thermal Study)
- Pre-column & post-column (Derivatization Method)
- Plasma Stability
- Inhibition studies (DPP IV activities)
Clinical Sample Analysis :
Skylimit’s team of qualified and experienced researchers with vast experience for regulated BA/BE PK analysis supported studies, including first-to-file, DDI studies, BE pilot, and pivotal studies for different regulatory.
Skylimit’s bioanalytical has all the analytical sophisticated instruments including LC/MS/MS, ICPMS equipments coupled with LC/UPLC/UFLC to cater to different studies and volumes of clinical samples for simultaneous analysis.
Small Molecule PK Analysis
Complex Bioanalytical Methods
Skylimit’s team has qualified and experienced researchers with vast experience in method development, method validation, and regulated bioanalysis for complex bioanalytical assays such as chiral compounds, compounds having metabolite back conversion, unstable compounds, endogenous compounds, liposomal products, hormones, amino acids, vitamin, and protein-bound drug. A few categories are -
- Chiral molecules
- Metabolites and impact study
- Geometric isomers
- Positional isomers
- Enzyme hydrolysis
- Nutrients (e.g. Vitamins)
- Molecules required derivatization to get desired ionization efficiency.
- Protein bound drug (unbound and total)
- Hormones
- Liposomal drugs (Free, bound and total)
- Higher sensitivity required (Inhalation products)
NCE Clinical Support :
Skylimit’s bioanalysis proficiency in handling new chemical entities (NCE) for different phases of clinical trials is backed by an experienced team of bioscientists experience in handling NCE molecules. Skylimit has highly sensitive equipment to support sub picogram level quantitation for the micro-dosing studies to assess the minimum effective dose. Our bioanalytical laboratory has vast molecule experience for different NCEs validated methods in different matrices with dynamic linearity ranges.
Peptide by LC/MS/MS :
Mass spectrometry is an indispensable tool for peptide and protein analysis owing to its speed, sensitivity, and versatility. It can be used to determine amino acid sequences of peptides and to characterize a wide variety of post-translational modifications such as phosphorylation and glycosylation. Skylimit’s team can provide solutions to its sponsors for their small peptide analysis. Previously we have worked on small peptides like liraglutide, insulin, etc.
Amino Acids Analysis :
At Skylimit, our scientists have developed and validated the bioanalytical methods for estimating the total 25 amino acids in human plasma using three different bioanalytical method(s). The validated methods were successfully applied to evaluate the pharmacokinetics, safety, and tolerability of various amino acids in healthy volunteers.