Analytical & Bioanalytical Capabilities
Dose Formulation Preparation
Scientific experience in the preparation of formulations (solutions, emulsions,
suspensions, capsules and patches) to support in vivo studies in multiple species.
Ability to work under Aseptic conditions, pH and Osmosis monitoring
Dose Formulation Analysis
Feasibility, method Development, Transfer, Validation and Dose Formulation Analysis
for small and large molecules by LC-UV, LC-Fluorescence, LC-MS/MS.
Platforms: HPLC Alliance 2695 (Waters), UV2487/2489 (Waters), Fluorescence 2475
(Waters)
Bioanalysis of Large Molecules by ImmunoAssay
We offer ImmunoAssay experience in PK/TK method transfer, development and
validation for the determination of biotherapeutic products to support regulated and
non-regulated preclinical programs for a variety of species and biological matrices. We
work to ensure the assay design is fit-for-purpose, understanding the bioanalytical
challenge of first-in-class products, biosimilars and biobetters while working with
biologics such as recombinant proteins, monoclonal antibodies and vaccines as well as
gene therapy based products for which we study the targeted expression of specific
transgenes.
ADA method development and validation
The immunogenicity of a biological drug can affect drug exposure interfering in the
interpretation of the toxicity and safety data in non-clinical programs. We offer
experience in method transfer, development and validation for specific anti-drug
antibody measurement through screening and confirmatory of samples as standard
characterization. Titering and Neutralization assays such as competitive enzymatic or
cell-based assays are additional services offered at preclinical stage as per customer-
oriented decision.
Biomarkers determination
Biomarker concentrations in biological matrices provide key information on therapeutic
effect. We offer advice on the best analytical approach for biomarker measurement and
interpretation applying fit-for-purpose basis within drug development program to
implement development and validation of methods.
Immunophenotyping and Cellular Response Assays
Flow cytometry is a powerful tool to provide valuable insights in immune-related
responses derived from the effect of biological drugs or vaccines. Immunophenotyping
allows the study and characterization of cell populations within immune system and we
offer standard and uncommon population panels for the most relevant preclinical
species. Functional assays allow the study of cellular responses against specific
stimulus such as T cell responses against viral vectors used in gene therapy. We are
currently offering both assessments at non-regulated level although our challenge is to
fit flow cytometry into the current regulatory landscape.
Platforms: Canto II (BD)
Bioanalysis of Large Molecules by LC-MS/MS
Method Development/Feasibility, fit-for purpose validation, validation and sample
analysis of Peptides, Oligonucleotides (SiRNA, DNA) and Proteins by LC-MS/MS
detection in multiple species and matrices.
Platforms: UPL Acquity (Waters), API4000 (Sciex), API5000 (Sciex), Triple Quad
6500+ (Sciex)
Pesticides, Phytosanitary Residue studies (Validations and ILV)
Development and Validation or Intra-Laboratory Validation (ILV) method for residue in
feed, food and environmental matrices by LC-MS/MS
Clinical Sciences
Biochemistry Area
AnaPath Research S.A.U. offers a Standard Biochemistry panel for the different
species used in the Pre-clinical studies and have a wide panel of biomarkers to meet
our sponsor’s needs.
Platforms
Cobas 6000
The Cobas 6000 analyzer series delivers high quality results based on experience,
innovation and advanced technologies:
- Reference-traceable results with minimal lot-to-lot variance
- High quality results by ensuring sample and result integrity
- Innovative tests on a standardized, automated platform
- Results standardized to other Cobas serum work area systems
The Cobas 6000 series is a fully automated, random-access, software Indications for
controlled system photometric analysis intended for use qualitative and quantitative in
vitro determinations using a wide variety of tests. It is optimized for high throughput
workloads in the professional environment using a combination of ion selective
electrodes (ISE) and a photometric analysis unit.
The module c501 analyzer is a fully automated, discrete clinical chemistry analyzer
intended for the in vitro quantitative/ qualitative determination of analytes in body fluids
(Serum/Plasma/Urine/LCR and Others).
AnaPath Research S.A.U. offers a Standard Biochemistry panel for the different
species used in pre-clinical studies and have a wide panel of biomarkers to accomplish
our sponsor’s needs.
Cobas u 411
The Cobas u 411 urinalysis analyzer is a semi-automated, bench top analyzer which is
designed to read strips via reflectance photometry. This equipment is designed to
measure bilirubin, blood, glucose, ketones, leukocytes, nitrite, pH, protein, specific
gravity, urobilinogen and color (if selected). These measurements are useful in the
evaluation of renal, urinary and metabolic disorders. These measurements are useful in
the evaluation of renal, urinary and metabolic disorders.
Hydrasys
Protein electrophoresis is a well-established technique routinely used in clinical
laboratories for screening of protein abnormalities in serum and other biological fluids.
The semi-automated gel electrophoresis instrument, HYDRASYS, has been developed
to provide a complete test panel with high sensitivity and good resolution.
We offer three types of separation for our Sponsors:
- The charge of the proteins, in a specific pH buffer. Serum proteinogram
- The isoelectric point, in a specific pH gradient. Antibody isotyping
- The molecular weight of the proteins, in an SDS-agarose gel. Protein characterization
Hematology and Hemostasis Area:
AnaPath Research S.A.U. offers a standard hematology and hemostasis panel for the
different species used in pre-clinical studies.
Technology available:
Advia 120 & 2120
The ADVIA 2120 Hematology System was released as a bench-top analyzer designed
for medium- to large-volume laboratories. This flow cytometry–based system uses light
scatter, differential white blood cell (WBC) lysis, and myeloperoxidase and oxazine 750
staining to provide a complete blood cell count, a WBC differential, and a reticulocyte
count. A cyanide-free method is used to measure hemoglobin colorimetrically. In
addition to its capability for analyzing peripheral blood specimens, the analyzer is also
equipped to analyze cerebrospinal fluid samples.
The instrument uses 5 channels to analyze blood samples: a hemoglobin channel for
the colorimetric measurement of hemoglobin concentration, a combined RBC and
platelet channel, 2 channels (the peroxidase and lobularity/nuclear density channels)
for WBC counts and differentials, and a reticulocyte channel. In the 2 WBC analysis
channels, for example, the blood sample is diluted approximately 50-fold so that 1 µL of
diluted suspension corresponds to 0.02 µL of the undiluted blood sample. Forty
microliters of this suspension are passed through the flow cell for analysis; therefore,
0.8 µL of whole blood is analyzed in each WBC analysis channel
STA Compact Max 2
STA Compact Max® is a fully automatic coagulation analyzer. A central processing unit
controls instrument functions such as management of patient results, quality control,
support for instrument maintenance, and workload optimization. The instrument utilizes
barcoding of test reagents, calibrators and controls that facilitate their use on the
system and permits reagent management simple. The proposed device has same
fundamental technological characteristics as the predicate device based on
Chronometry Measurement Principle and Photometry Measurement Principle.
The detection of chromogenic assays is based on the absorbance (optical density:
O.D) of monochromatic light passing through the cuvette as a chromogenic reaction
takes place. Incident light entering the cuvette is partially absorbed by the reaction
mixture as it passes through. The transmitted light is measured and converted to
absorbance. The Beer-Lambert law is applied to convert absorbance to concentration
of the substance being measured.
Microscopy evaluation
AnaPath Research S.A.U. offers an extensive experience on microscopy evaluation of
hematological and urinary sediment. At our facilities we have different microscopy
technologies to cover all our sponsor’s needs on the preclinical and non-clinical
evaluations.
Molecular biology area:
At AnaPath Research S.A.U., we offer the full GTMP non-clinical study program to fulfill
the proper benefit-risk assessment for the use of such products in humans. AnaPath
Research S.A.U. is ready to fully coverage both toxicological investigations and
pharmacokinetic studies designing the GTMP non-clinical development on a risk-based
approach.
Both the GMTP risk associated and the potential in vivo will directly depend on the
transgene or other recombinant nucleic acid sequences, the vector backbone (i.e. viral,
bacterial or plasmid derived sequences) and the excipients including any carrier or
support medical device employed.
GTMPs are constructed with specific purposes in terms of the biodistribution, cell or
tissue specificity and tropism, and gene product expression. In principle, most safety
aspects of GTMP might be anticipated when combining knowledge on the components
to the biodistribution profile in vivo and at the cellular level where appropriate. The
toxicological evaluation of the GTMP will therefore consist mostly of the search for
anticipated or predicted toxicities, their characterization, and when possible, their
quantification (dose-response relationship) to define the safe conditions of human
therapeutic use.
