Research Support Services
Our agility in providing end-to-end laboratory solutions also means that Vectura Fertin Pharma Laboratories can be your partner at any point of your preclinical journey through our a la carte services.
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Histological and Immunohistochemistry (IHC) Processing
At Vectura Fertin Pharma Laboratories, we offer a comprehensive selection of diagnostic services for a wide variety of pathological diseases. Our dedicated team of histologists and in-house International Academy of Cytology (IAC)-certified cytologist are able to provide the following services:
- Routine histoprocessing:
- Grossing, tissue processing, embedding, microtomy, frozen section/cryotomy, slide scanning/digital pathology
- Histochemical staining solutions:
- Hematoxylin and eosin (H&E) stain, special stains, and immunohistochemistry and immunofluorescence analyses
- Gynecological and non-gynecological cytology diagnosis:
- Pap smear, fine-needle aspiration (FNA), blood smear and bone marrow smear
Analytical and Bioanalytical Analysis
Our GLP-certified analytical and bioanalytical laboratory offers full-service solutions for inhalation and dosing formulation development and characterization of test articles as well as estimation of drug concentrations in a biological matrix. Our broad range of chromatographic instruments for delivering analytical and bioanalytical results include HPLC, GC-FID, GC–MS/MS, UPLC–MS/MS, and LC–MS/MS.
Bioanalysis of Test Articles for Aerosol Generation and Characterization
Formulation development and characterization of test items
- Drug concentration and stability testing under handling conditions
- Homogeneity
- pH measurement
- Microbial testing and endotoxin report
Determination of constituent concentrations in aerosols
- Development of analytical methods
We develop fit-for-purpose analytical methods using GC-FID, GC–MS/MS, or HPLC systems to analyze test articles in trapped aerosols for undiluted and diluted samples from exposure chambers
Validation of analytical methods
- All validation parameters are evaluated in compliance with ICH guidelines
Analysis of aerosol concentrations at intervals during animal exposure
Bioanalysis of Test Articles for Toxicokinetics and Phamacokinetics Studies (TK/PK)
Development of bioanalytical methods
- Bioanalytical methods are developed for biological matrices such as blood, urine, and plasma samples, using suitable extraction techniques (solid-phase extraction, protein precipitation, liquid–liquid extraction). These bioanalytical methods are developed and applied using LC–MS/MS or HPLC systems for analysis of test articles and their metabolites in processed samples for PK or toxicokinetics analysis
Validation of bioanalytical methods
- All validation parameters are evaluated in compliance with FDA guidelines
Toxicokinetics and Pharmacokinetics
- Modeling and extraction of PK parameters
- Cmax, Cmin
- Tmax, Tmin, T1/2
- AUC
- Elimination rate, clearance, etc.
- Analysis of irritancy effects of inhaled test articles
- Lung function (plethysmography)
- Acute inflammation and other marker panels (BALF and Luminex analyses)
- Comparison of various administration routes and effects on ADME
- Dosing regimen for efficacy and safe studies
Clinical Pathology
A wide range of clinical pathology assays and instruments are available for preclinical studies in rodents:
- Hematology analyses (whole blood)
- Clotting potential (plasma)
- Clinical chemistry analyses (serum/plasma, urine, and BALF)
- Blood gas analysis (pO2, pCO2, and pH), carboxyhemoglobin (COHb)
- Glucose measurements (whole blood)
- Urinalysis
Regulatory Data Management (SEND)
We specialize in providing Standard Exchange of Nonclinical Data (SEND) that is compliant for submission to the US FDA and Japan PMDA. We have streamlined, automated processes for reconciliation and consistency enforcement on data management methodologies. Our dedicated team of data specialists is ready to address your SEND-compliant data requirements to accelerate your journey towards a smooth regulatory submission.
