Below you will find a partial listing of testing
services available. We can customize any of our
test models to comply with the needs of your individual
project. Feel free to contact
us with any questions.
R
& D Support Services
BATTS Laboratories offers a complete
range of antibody services, immunochemistry procedures,
and preclinical studies for drug development and
to support IND, NDA, and PLA submissions. BATTS
Laboratories has standard protocols for many studies,
or we can help you develop a custom protocol.
We have gained a national reputation for quick
turnaround time, quality in service, and excellence
in toxicology.
Preclinical
Studies of Pharmaceuticals and Biologics
Pharmaceutical and biopharmaceutical tech companies
rely on well conducted preclinical toxicology
and pharmacology studies to:
- Meet
FDA and international requirements for new drug
submissions.
- Evaluate
the efficacy of new drug products quickly and
accurately
- Help
insure patient safety
- Provide
critical information for clinical trials
BATTS
Laboratories has an experienced staff that can
work with you to design and execute preclinical
studies of biotech-derived products and traditional
pharmaceuticals. Our rigorous quality assurance
program and outstanding regulatory track record
help guarantee there will be no surprises with
your product submissions. All studies comply with
applicable GLP regulations.
Preclinical
Toxicology
- Acute
Toxicology – Custom Protocol
- Subacute
Toxicology – Custom Protocol
- Intraperitoneal
Subchronic Toxicity
- Intravenous
Subchronic Toxicity
- Subchronic
Toxicity – Custom Protocol
- Immunogenicity
- Surgical
Method Development
- Product
Safety Evaluations
- Custom
Studies
- Histopathology
- LD-50
- Maximum
tolerated dose (MTD)
- Acute
Toxicity
-
Subchronic Toxicity
- Chronic
Toxicity
- Single
dose range-finding and acute toxicity studies
- Repeated
Dose
- Sensitization
- Irritation
- BCGM
Assays
- Carcinogenicity
Studies
Pharmacokinetik/Pharmacodynamic
Studies
- Absorption,
Distribution, Metabolism, & Excretion (ADME)
- Chemical
Pathology
- Dose
Range Determination
- Dose
Confirmation/Analysis
Preclinical
Efficacy
BATTS Laboratories has particular expertise in
preclinical evaluations of adjuvants and vaccines.
Full
clinical chemistry, hematology, and histopathology
services are available. Upon request, these services
will be conducted under the direct supervision
of a board certified veterinary pathologist. Full
ophthalmologic evaluations are also available.
Studies can be conducted in rats, mice, rabbits,
guinea pigs, canines, or swine.
R & D Support Services – Disease
Models
BATTS Laboratories toxicologists have experience
with a wide range of infectious and other disease
state models for evaluating candidate therapeutics
or prophylactic treatments. Our staff will conduct
literature searches, collaborate with you on protocol
design, and handle all aspects of IACUC review
promptly and responsively.
Studies
are conducted by well-trained Study Directors
and technicians in compliance with BATTS Laboratories
rigorous quality systems. U.S. or international
GLP treatment is available.
Study
reports are well-written, thoroughly reviewed,
and submitted to you on time.
Infectious
Disease Models:
-
Viral
- Bacterial
- Protozoa
(including Cryptosporidium)
Other
Models
-
Inflammation
- Wound
Healing
- Cell
Proliferation
- Skin
Diseases
Available
species include:
- Rabbits
- Rats
- Mice
- Guinea
Pigs
- Hamsters
- Chickens
- Goats
- Swine
Treatments
may be administered via the following routes of
administration:
-
Oral
-
Dermal
-
Subcutaneous
- Intracutaneous
-
Intraperitoneal
-
Continuous Infusion
- Intratracheal
- Intracochlear
(click for photo)
Antibody
Production
BATTS Laboratories offers custom antibody product
services. Pricing of immunology projects may vary
according to specific protocols, difficulty of
sample preparation and special handling requirements.
Please contact us or submit our Request for Quotation
form for more information.
All
testing complies with applicable Good Manufacturing
Practice (GMP) and Good Laboratory Practice (GLP)
regulations. Our animal facilities meet the highest
USDA and NIH standards. BATTS Laboratories has
an outstanding track record of regulatory compliance.
We are committed to excellent client service.
We will appreciate the opportunity to discuss
your testing requirements.
New
Sun Protection Factor Testing
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Contact Us if you are
interested in acquiring our services or need more
information. |