Bioanalytical Services
Bioanalytical Services
Feasibility, Method Development & Method Validation
Veeda provides feasibility evaluation to sponsors based on different literature support before execution of a trial. We at Veeda are committed to providing detailed Bioanalytical feasibility to understand and estimate the complexities involved during execution.
Clinical sample analysis
Veeda’s Team of qualified and experienced researchers with vast experience for regulated BA/BE PK analysis and supported more than 3000 studies including First to file, DDI studies, BE pilot and pivotal studies for different regulatory.
Veeda bioanalytical has different 46 LC/MS/MS equipments coupled with LC/UPLC/UFLC to cater different studies and volume of clinical samples for simultaneous analysis. Veeda has more than 600 validated methods to support clinical studies. For details the Method library can be referred.
Pharmacokinetic analysis
Small Molecule PK analysis
Complex Bioanalytical Methods
Veeda’s team has qualified and experienced researchers with vast experience in method development, method validation and regulated bio analysis for complex bio analytical assay such as chiral compounds, compounds having metabolite back conversion, unstable compounds, endogenous compounds, liposomal products, hormones, amino acids, vitamin and protein bound drug. 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)
| Segment | Veeda's Expertise |
|---|---|
| Vitamins & Hormones | Since vitamins & hormones occur naturally in plasma, quantifying the impact resulting from drug intake is a challenging process; |
| Inhalation Products | Veeda has the capability to detect, isolate, and quantify the extremely small quantities of inhalation drugs in a given biological matrix |
| Long acting Depot Injectable Suspension |
Veeda has the capability to detect, isolate, and quantify the small peptides in a given biological matrix |
| Isomer Separation | Experienced in the use of comples column chemistry to separate and quantify isomers |
| Complex molecules | Handle complex molecules - Stability issue, ionization issue and separation from metabolites |
| Liposomes | Requires buffer addition to aliquots in precise amounts determined by plasma/serum separated from each sample |
Elemental Bioanalysis
ICP-OES (Inductively Coupled Plasma Optical Emission Spectrometry) methods of analysis are being used to quantify the concentration of elements contained in pharmaceutical compounds. Validation of methods for quantification of elements in biological metrics such as whole blood, serum, plasma and urine may be performed following GLP predicate rules and bio analytical guidance. Veeda has experience in carrying out studies for different elements in different types of biological metrics.
NCE clinical support
Veeda Bioanalysis proficiency in handling new chemical entities (NCE) for different phase of clinical trials is backed by an experienced team of bio scientists having over 10 years of experience in handling NCE molecules. Veeda have highly sensitive equipment’s to support Subpicogram level quantitation for the micro dosing studies to assess minimum effective dose.Our Bio analytical lab have vast molecule experience for different NCEs and have more than 64 validated methods in different matrices with dynamic linearity range.
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. Veeda’s team can provide solutions to its sponsors for their small peptide analysis. Previously we have worked on small peptide like Liraglutide, insulin etc.
Amino Acids Analysis
At Veeda, our scientist have developed and validate the bioanalytical methods for estimation of total 25 amino acids in human plasma by using three different bioanalytical method(s). The validated methods successfully applied to evaluate Pharmacokinetics, Safety and tolerability of various amino acids In Healthy Subjects.
Large Molecule Bioanalysis
Ligand binding assay
Veeda has specially trained team on ELISA assays to carry out Biosimilar analysis and validation of such methods as per regulatory requirements (USFDA and EMA) specified in guidelines for bioanalytical method validation of ligand binding assays.
Veeda has developed and validated large molecules as per current EMEA guidance using commercially available kits by ELISA technique such as G-CSF, Insulin Aspartetc
MS/MS assay
Typically, large molecules are analyzed using ligand-binding assays but with advanced progress in MS technology the scientific community has seen increased success in overall sensitivity and selectivity. Our Bioanalytical lab has specially trained team to carry out large molecule analysis by LC-MS/MS technology as per regulatory requirements
Pharmacodynamics Analysis
Pharmacodynamics (PD) analysis allow drug developers to quantify the relationship between the drug dose and the pharmacologic or toxicologic effect it has on patients. The results of PD studies can often be impacted by the response of the receptor. This is often the due to the presence of drugs competing for the same receptor. The team has capability to design and perform such assay utilizing the commercially available PD assay kits using ELISA/ECLIA method by spectrophotometric analysis. Veeda team has capability to design and perform such assay utilizing the commercially available PD assay kits.
Veeda has experience of PD analysis such as nitrate/nitrite, Anti Xa, Anti IIa, TFPI etc.by using validated methods.
Immunogenicity
Immunogenicity assessment is the part of Biosimilar drug submission which is required to check any immune response created in the body in against of Biosimilar drug. The immunogenicity assessment is done in four parts.
- Screening assay
- Confirmatory assay
- Titer assays
- Cell based assay
The Veeda team has capability to do the all immunogenicity assay method validation as per regulatory requirements.
Biomarker
Biomarkers have been used in clinical research and clinical diagnosis for a considerable time. Biomarkers are useful in a number of ways, including measuring the progress of disease, evaluating the most effective therapeutic regimes etc. Veeda has experience of few biomarker analysis such as C-peptide, alpha acidic glycoprotein by using validated methods.
Central Laboratory Services
Dedicated team for Central Lab Services which includes
- Project Manager
- Project Coordinator
- Sample management team
- Kits & Logistics coordinator
- Analytical Team (PK analysis based on project’s requirement)
- Watson LIMS Team
The Veeda team has capability to do the all immunogenicity assay method validation as per regulatory requirements.
Lab manual preparation
We have well trained team who can prepare the lab manual and ship the required sample collection kits to clinical sites. We at Veeda use sponsor specific template or Veeda’s standard template is being to prepare the lab manual for PK sample collection details.
Management of Clinical Site Samples
The dedicated sample management team is available for coordination of communication and sample management at Veeda for 24*7 supports.
Kit supply and logistic
We assemble and distribute protocol-specific specimen collection kits to simplify and streamline the pharmacokinetic (PK) collection process for single and multi-site clinical trials.
Consultancy Services
Our experts are available to provide guidance at any point during your studies
Specialized LC/MS/MS Analysis Support
Dried Blood spot samples
At Veeda, we have hands on experience on the method development of Dried Blood Spot Technique for the Quantification of Capacitabine, a Pyrimidine analog in Human Blood. Veeda presented its work in the APA 2012.
Micro capillary sample handling
Our Team of qualified and experienced researchers with vast experience in method development, method validation and regulated bio analysis for complex bio analytical assay are capable to handle the analysis of analyte from the Micro capillary sample under the regulated environment.
Plasma Protein Binding
Non-specific binding experiments
Fit to purpose method Qualification and analysis for Skin, tissue matrices
- Bio analysis of drugs and their metabolites in tissues/skins can play an important role in understanding the pharmacological and toxicological properties of new drug candidates.Different methods of calibrator and QC samples are currently employed, providing sufficient stability of the analyte, fortification allow adequate time for bio matrix interaction
- Veeda’sexperienced researchers with in- depth experience in method development, method validation and regulated extrapolate analysis for skin and tissue homogenates, contact lenses etc.
Why Veeda?
- Veeda is an Independent Indian CRO with 16 years of experience.
- Veeda has conducted over 3400+ studies & has worked with over 200 (Bio) pharmaceutical companies around the world.
- Veeda has an exemplary regulatory record of successfully completingaudits of USFDA, AGES, MHRA, ANVISA, WHO, NPA, ANSM, MCC, DCGI & NPRA
- Due to stringent quality norms and transparency at all stages, Veeda is considered to be a preferred partner for many (Bio) Pharmaceutical companies
- Veeda’s has a vast experience in scientific and regulatory compliant protocol designing that enables the drug development process of Early to Late phase clinical trials
- Veeda has over 600+ analytical methods & 60+ NCE molecules developed and validated so far
- Veeda ensures study specific clinical safety measures for all subjects through risk mitigation strategies
- Veeda has Quality Management System in place to capture any non-compliance or deviation identified during the study with an effective mechanism of corrective and preventive actions implemented
