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Drug and Vaccine Studies

 

   
Drug & Vaccine Studies Drug Development Support Services Custom Antibodies
In Vivo Models Inflammation Xenograft Studies PK / TOX Rapid-turnaround

 

Drug and Vaccine Studies

The animal species available for test protocols include mice, rats, guinea pigs and rabbits.

We have a wide variety of procedures for administration of Test Materials including injections (subcutaneous, intraperitoneal, intravenous, intradermal, intrathecal), oral and intratracheal routes.

Our sampling services include collection of serum or plasma, or cerebrospinal fluid and organ removal at necropsy.

Before we begin work on your project, we will have a clearly defined protocol for your acceptance. We will supply our Protocol, with modifications as needed to fit your requirements, or work from your Protocol.

Services for Efficacy Assessment
  • Pharmacokinetics
  • Metabolism Studies
  • Disease-specific Compound Screening In Vivo
  • Cell Culture Assays for In Vitro compound screening
  • Safety/Toxicity
  • Immunogenicity Studies

Pharmacokinetics

Our experienced staff provides quality PK testing in mice, rats, guinea pigs, hamsters and rabbits (all species from accredited U.S. suppliers).
 

 - Expert dosing by any route of administration: IV, PO, SC, IP, Infusion, Intranasal, Topical or Intrathecal. 
 
 - We feature fast-turnaround and low cost studies with  clear and frequent client communications.

- Pricing competitive worldwide.

- Full-time Experienced Technical Staff and Project Management assures you of easy contact and full attention.
 
- Highest Quality Laboratory Animals.
 
- Detailed Protocols give you assurance that your project is carried out with the best quality reagents and laboratory animals.

 - Professional Communications featuring weekly (or better) Project Status Reports
 
 - Completely detailed Final Reports (documented sources for
all materials and animals)
 
  
Now in our 22nd year of in vivo testing services for compounds, proteins and vaccines, Washington Biotechnology, Inc. has a broad and growing array of disease models supported by our PK, TOX and Necropsy Services.

Our necropsy services include removal, weights, preservation and collection of designated organs for histology or shipment to your laboratory.
 

Please inquire for further information.



Toxicity Tests

TOX studies (acute, chronic) - fast start-up, within 2 weeks of your order.

An early consideration for a new chemical entity intended for human therapeutic or veterinary application is assessment of its toxicity. We offer a complete menu of animal models and dosing procedures to answer all of your informational needs in assessment of acute or chronic toxicity.

Cytotoxicity - Cell Culture 1 week
Acute Toxicity -Mouse or Rat 14 days
Chronic Toxicity - Mouse or Rat 56 days


Test materials are administered by injection, oral, or intratracheal administration. Plasma or sera are collected at designated time intervals for prompt shipment to your laboratory.

Our necropsy services include removal, weights, preservation and collection of designated organs for histology or shipment to your laboratory.

Please inquire for a no-obligation proposal and quotation for your project. We will develop a project plan and schedule specifically designed to answer your research or preclinical questions. Our proposals are specifically tailored to fit the scope of your enquiry, whether preliminary or full preclinical. We believe in flexible project plans to meet our customer's budgetary and scheduling needs.


 


Safety Tests


An important facet of product development is the evaluation of preparations for contamination by toxins or pyrogens. Washington Biotechnology offers standard tests such as the General Safety Assay (GSA) and Rabbit Pyrogen Assay (RPA) for determination of possible toxic or pyrogenic activity.

The GSA and RPA tests are usually required by the United States Food and Drug Administration for pre-release quality control testing of each manufactured lot of a human therapeutic. We recommend these assays at the research, development and preclinical stages to avoid delays in clinical trials and product licensing.

General Safety Assay (GSA) USA
Test Injection: 2 Guinea Pigs and 2 Mice
Observation Period: 7 days
Catalog No. Price
WBI-GSA-US $600 USD
 
General Safety Assay (GSA) – Europe
Test Injection: 2 Guinea Pigs and 5 Mice
Observation Period: 7 days
Catalog No. Price
WBI-GSA-EU $650 USD
 
Rabbit Pyrogen Assay (RPA) – USA/Europe
Test Injection: 3 Rabbits
Body Temperature Monitoring: 3 hour period
Catalog No. Price
WBI-RPA $700 USD



Immunogenicity Studies

We are experienced with both the basic and extended protocols of immune response screens.

In the basic immune response screen, Swiss Webster mice or Sprague-Dawley rats are used to evaluate the immunogenicity of the test material over a 38-day period. The standard protocol is:

Immune Response Evaluations
Catalog No. Procedure Day Price Per Animal
  Prebleed & Injection 1 0  
  Injection 2 14  
  Injection 3 28  
  Terminal Bleed 38  
  Antibody Titer by ELISA    
WBI-IR-mouse (0.3-0.5 ml serum) $60 USD
WBI-IR-rat (3-5 ml serum) $80 USD

For extended studies involving the immune response and kinetics, please Contact Us.




Disease-specific Drug Screening (In Vivo)

Inflammation Models


Carrageenan Model – Rat 1-day assay
Irritant-induced Inflammation Models – Mouse
2-week assay
Air Pouch Model – Rat 2-week assay

Data analysis with either model includes the basic paw swelling measurement supplemented as requested with chemistries, cell counts, cytokine measurements and histopathological analysis of bone at affected joints.

These models are useful in the initial in vivo evaluation of anti-inflammatory compounds developed for the treatment of diseases such as rheumatoid arthritis and multiple sclerosis. The basic measurement in the first two models is measurement of edema in response to irritants. In the third model, the production of cytokines is measured in response to irritation with or without drug treatment.

Test materials are administered by injection, oral, or intratracheal administration. Plasma or sera are collected at designated time intervals for prompt shipment to your laboratory.

Please inquire for a no-obligation proposal and quotation for your project.


Arthritis Models

Collagen Induced Arthritis (CIA) – Mouse 45-day assay
Adjuvant-induced Arthritis (AIA) – Rat 50-day assay

In addition to the basic assay measurements of paw edema, valuable supplementary data can be obtained through:

  • Clinical chemistries on plasma samples
  • Complete cell counts and differential cell counts on blood samples
  • Cytokine measurements
  • Histopathological analysis of affected joints
Test materials are administered by injection, oral, or intratracheal administration. Plasma or sera are collected at designated time intervals for prompt shipment to your laboratory.

Our necropsy services include removal, weights, preservation and collection of designated organs for histology or shipment to your laboratory

Please inquire for a no-obligation proposal and quotation for your project.




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Analgesic Models


Formalin-induced Nociception - Rat 1-day assay


Many anti-arthritic drugs used in the clinic are effective against the inflammation, but have minimal effect on the pain accompanying the disease. We offer a protocol to evaluate the anti-nociceptive effectiveness of your lead anti-inflammatory compound.

Test materials are administered by injection, oral, or intratracheal administration. Plasma or sera are collected at designated time intervals for prompt shipment to your laboratory.

Please inquire for a no-obligation proposal and quotation for your project.


Diabetes Model

Streptozocin-induced Diabetes - Rat 30-day assay


Rats treated with the antibiotic Streptozocin provide our model for studying the effectiveness of potential anti-diabetic agents. Diabetic condition in each rat is assessed by blood glucose measurements to select rats for the treatment of Test Materials. The treatment study parameters include urine collection studies with assay for albumin excreted in urine to provide a Urinary Albumin Excretion Rate (UAER). Ancillary measurements include glucose, ketones and blood in urine. We provide a statistical analysis of the UAER data in our Final Report along with the glucose and other measurements used to select diabetic rats for treatment.

Test materials are administered by injection, oral, or intratracheal administration. Plasma or sera are collected at designated time intervals for prompt shipment to your laboratory.

Our necropsy services include removal, weights, preservation and collection of designated organs for histology or shipment to your laboratory.

Please inquire for a no-obligation proposal and quotation for your project.


Bacterial Infection Models

We have the facilities to culture many different types of pathogenic bacteria for the evaluation of the efficacy of potential antibiotics in rodent models. The bacteria are administered by various routes to model a variety of disease states from food poisoning to lung infection to burn infections. Assay end points include bacterial counts in blood samples and in selected tissues.

Test materials are administered by injection, oral, or intratracheal administration. Plasma or sera are collected at designated time intervals for prompt shipment to your laboratory.

Our necropsy services include removal, weights, preservation and collection of designated organs for histology or shipment to your laboratory.

Please inquire for a no-obligation proposal and quotation for your project.


Cancer Models

We evaluate the potential anticancer efficacy in nude or SCID mice maintained in our HEPA-filtered biohoods. Our tissue culture capabilities include services for growing cancer cell lines and cell counts prior to implantation. Efficacy of treatment is evaluated according to your requirements, whether prevention of malignant tumor growth or reduction/elimination of established tumors. Tumor size measurements are the basic data.

Test materials are administered by injection, oral, or intratracheal administration. Plasma or sera are collected at designated time intervals for prompt shipment to your laboratory.

Our necropsy services include removal, weights, preservation and collection of designated organs for histology or  shipment to your laboratory.

Cancer Screening 

 

Washington Biotechnology services now include animal efficacy models for screening test compounds with potential for treatment of human breast, colon, peripheral blood, lung, lymph nodes, skin, pancreas, prostate, ovarian and thyroid cancer. We use well-established mouse tumor models for cost-effective screening and to generate valuable dose-response results. Our models can also be used to include collection of pharmacokinetic data for the test compound.

 

Our Xenograft Models include:

 

Human Breast Cancer, MX-1 cell, SCID or athymic nude mouse, 20-30 day studies.

 

Human Colon Adenocarcinoma, HT29 cell, SCID or athymic nude mouse, 20-30 day studies.

 

Human Liver,  H358 cell,  SCID or athymic nude mouse, 20-30 day studies.

 

Human Prostate, PC3 cell, SCID or athymic nude mouse, 20-30 day studies.

 

 

For detailed information on test protocols and pricing, including how we can customize studies to fit your requirements, please contact us. We will be glad to provide a cost effective custom protocol and quotation for your evaluation.



Drug Efficacy Models (In Vitro) - Cell Culture Assays

A number of cell culture assays provide valuable insights into the efficacy of anti-inflammatory drugs in prevention of cytokine expression. We measure the effect of your drug on cytokine production in a cell culture model for inflammation.

Please inquire for a no-obligation proposal and quotation for your project.

LPS-Stimulated Rat Spleen Cells - Measurements of Cytokine Responses with and without addition of Drug.

"Whole Blood Assay" (fresh human blood cells stimulated with LPS for cytokine expression) - Measurements of Cytokine Responses. We use this cell culture assay to model human inflammatory response and the efficacy of your drug inhibiting the response.


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We assay for production of cytokines such as:

  • TNF-alpha
  • IL-2
  • IL-6
  • IF-gamma
  • IL-8


Your Resource for In Vivo Accuracy





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