SeroScience

Services

Academic Creativity, GLP Reliability

All services are available in Full GLP, GLP-like, or non GLP environments, depending on your aims and budget.

Unique Expertise In


CARPA Assays

In vivo analysis of test drug-induced hemodynamic, hematological, biochemical, immunological and skin alterations. The experiment may be conducted on juvenile domestic pigs (the most sensitive platform), dogs, rats and mice. During the experiment the following parameters are acquired and analyzed:

  • Pulmonary Arterial Pressure (PAP)

  • Systemic Arterial Pressure (SAP)

  • Cardiac Output (CO)

  • Heart rate (HR)

  • Electrocardiogaphy (ECG)

  • Expiratory/end-tidal Carbon Dioxide pressure (pCO2)

  • All Blood Cell Counts

  • White Blood Cell (WBC) differential

  • Coagulation Parameters

  • Skin reactions (rash, flushing)


Immunogenicity Assays

In vivo immunogenicity studies in the following model animals:

  • pig

  • dog

  • rat

  • mouse

In vitro assessment of anti-drug and anti-carrier antibodies, natural and induced.

  • Anti-drug IgM and IgG antibodies (ADAs)

  • Anti-phospholipid, anti-cholesterol antibodies

  • Anti-insulin and other antibodies against proteins/peptides


Consultancy

Professional advice on

  • Optimization of particle surface composition and size in order to decrease infusion reaction (CARPA) liability

  • In vitro, in vivo and clinical study design and regulatory reporting for immune system-related toxicity

Immunotoxicity Assays

In vitro assessment of standard and immune response-related hematological descriptors.

  • WBC, RBC, platelet and lymphocyte counts and WBC differential

  • Plasma thromboxane, PAF, histamine, leukotrienes, tryptase

In vitro assessment of test drug-induced complement activation in serum/plasma/whole blood.

  • Assessment of human C3a, C5a, C4d, Bb, SC5b-9

  • Assessment of C3, all species (PAN-C3)

  • Assessment of iC3b opsonization and terminal complex (C5b-9) deposition

  • SRBC (CH50) hemolytic assay, all species

In vitro assessment of test drug-induced Basophil activation in serum/plasma/whole blood.


Formulation of Complex Drugs

  • Formulation of Drug Carriers

  • Formulation of Vaccines

  • Drug Characterization

 

All Services


Immunotoxicity

  • Immunotoxicological evaluation within toxicity studies

  • Anti-drug antibody assay (ADA)

  • Immunohistochemistry of immune tissues

  • Measurement of protein/nucleic acid level with ELISA

  • Measurement of protein/nucleic acid level with Luminex Multiplex Assay

  • T-cell dependent antibody response (TDAR)

  • Cytotoxic T-cell (CTL) function assay

  • Natural killer cell (NK) activity assay

  • Immunocell phenotyping

  • Cytokine release assay

  • In vitro T-cell proliferation assay

  • Complement dependent cytotoxicity (CDC)

  • Complement Activation Related Pseudoallergy assay (CARPA)

  • Antibody dependent cell-mediated cytotoxicity (ADCC)


Irritation and Delayed-type Hypersensitivity 

  • Magnusson and Kligmann maximisation test

  • Local lymph node assay in the mouse

  • Intracutaneous reactivity in the rabbit

  • Skin irritation test in the rabbit (single and repeated exposure) / medical device

  • Acute skin irritation test in the rabbit

  • Acute eye irritation test in the rabbit

  • Immediate hypersensitivity reaction (IHR) / Passive Cutaneous Anaphylaxis (PCA)

  • Local effects after implantation of medical device


Bioanalytical activities

  • Bioanalytical method development

  • Bioanalytical method validation

  • Bioanalytical part of toxicokinetic studies

  • Bioanalytical support of clinical trials

General toxicology

  • Dose range finding

  • Single dose toxicity study / Extended single dose toxicity

  • Repeated dose toxicity studies

  • Local tolerance testing (in vivo)

  • Target animal safety studies


Genotoxicity

  • Bacterial reverse mutation test (Ames test)

  • Mammalian erythrocyte micronucleus test

  • XTT cytotoxicity assay

  • Colony forming assay in V79 cells

  • In vitro mammalian cell gene mutation assay

  • Mammalian chromosome aberation test


Batch realease testing

  • In vitro potency assay of the expression level of protein of interest

  • In vitro potency assay of the infectivity of an oral vaccine


Pharmacodynamics

  • Wound healing in db/db mice or in Zucker-rat

  • Wound healing in the (mini) pig

  • Euglycemic clamp test

  • Glucose tolerance test


Pharmacokinetic studies

  • Single and multiple dose pharmacokinetic studies

  • Bioequivalence studies in animals

  • Pharmacokinetic support of pharmacological/toxicity studies

  • Bioavailability study

  • In vitro plasma protein-binding

  • CaCo-2 transmembrane permeability/ efflux assay

  • Providing blank samples for bioanalytical activity

Safety pharmacology studies

  • Safety pharmacology core battery: Nervous system

  • Safety pharmacology core battery: Respiratory system

  • Safety pharmacology core battery: Cardiovascular system


Other in vitro tests / standard and special services

  • Hemolysis assay

  • Coagulation assay

  • ELISA method transfer/development and validation

  • Immunohistochemical analysis

  • Tissue cross reactivity

  • Local effects after implantation of medical device


Laboratory services

  • Histopathology

  • Luminex

  • FACS

  • ELISA

  • Bioanalysis (HPLC, LC/MS/MS…)

  • Clinical pathology


Metabolism studies

  • In vitro metabolic stability

  • In vitro inter-species comparison of metabolism

  • In vitro and in vivo metabolic profiling

  • Tentative metabolite identification


Quality control activities

  • Formulation analysis of dose formulations in toxicity studies

  • Formulation analytical method development

  • Formulation analytical method validation

  • Support for formulation development


Tissue distribution

  • Tissue distribution study with non-radiolabeled test items