Contract Laboratory has received the following Preclinical Laboratory Test Requests which need to be fulfilled! These Laboratory Test Requests are received from a variety of sources ranging from start-up companies to large, multinational Fortune 500 corporations, international organizations, well-respected universities and government agencies that are actively seeking Independent, Third-Party Preclinical Laboratories to perform their Preclinical Testing, Analysis, Assays, Product Development, Scientific Research Experiments, Inspections, Certifications, and Engineering Projects. If you are a Preclinical laboratory that would like more information on these Preclinical projects, please visit our registration page or call toll us free 1-855-377-6821.
Preclinical laboratory needed for method development of an immunofluorescence method to be used for nuclear beta catenin and applied to preclinical studies with human cancer tissue and to clinical trial specimens.
Due to nature of drug action, method must be specific for detection of nuclear, and not cytosolic, beta catenin. Method will require confocal microscope. We have the antibody for nuclear beta catenin available commercially.
Veterinary Medicine preclinical opthalmology contract research organization (CRO) needed for an in vivo study of a drug product for a veterinary ophthalmology resident research project. Client is interested in administering the medication q8 hours to >10 healthy adult cats for 12 weeks.
Oncology Preclinical Contract Research Organizations CRO needed for in vivo studies of primary or metastatic hepatic / liver cancer using VX2 rabbit and/or Walker 256 rat/mouse orthotopic models. CRO must allow drug payload to be delivered by an external magnetic set up, steered by an MD/bioengineering member of our team.
Preclinical Contract Research Organization neededed for Influenza vaccination efficacy study in a specific strain of KO mice. Vaccination followed by challenge with live virus. Plasma should be collected before vaccination and at 4 weeks. This should be followed by challenge with the Influenza virus and two weeks of survival curve .Vaccination would be delivered IM and infection delivered intranasally as in humans.
URGENT TESTING FDA GMP Medical device preclinical laboratory needed for product safety and toxicity studies of a plastic dental aligner. Risk Assessment in regards to human exposure (oral, dermal, inhalation) is requested for a dental aligner and support-removal media. The dental plastic aligner is thermoformed onto a 3D printed mold that was previously soaked in our support-removal media.
Medical Device preclinical contract research organization CRO needed for insulin characterization with or without infusion through medical device: (1) High molecular weight proteins (insulin aggregates), (2) Preservative content (m-cresol), (3) Impurities, (4) Bioidentity (blood glucose response in rabbits), (5) Zinc content and (6) insulin recovery.
FDA GLP Preclinical Laboratory needed for PCR viral testing of two regenerative drug products and raw materials using Pharmacopeia methods:
1. HIV (anti-HIV (I/II),
2. Human T-Lymphotropic virus I and II
4. Epstein-Bar virus
5. Hepatitis C
6. HBV (HBsAg & anti-HBC)
In order to stay in line with the pharmacopeia guidelines, we would like to perform detection of the former viruses on our products with the PCR method.
FDA GMP medical device laboratory needed for preclinical product safety testing: biocompatibility (10993) sensitization, cytotoxicity, irritation and and electrical(60601) testing for class II medical device with focus on FDA application. We need GPMS sensitization, cytotoxicity, muscosal irritation tests conducted. For 60601, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1 reports are needed.
Preclinical laboratory needed for performing a number of in vitro studies using stromal vascular fraction (SVF) cells.These studies involve labeling of SVF cells with magnetic microparticles and superparamagnetic iron oxide nanoparticles (SPION).
We want to measure the following parameters:
1-Assess cell viability, self -renewal capacity and proliferation capacity. of SVF cells exposed to SPION.
2-Confirm the intracellular uptake of SPION by SVF cells using one or more of the available techniques to determine intracellular iron or SPION content per cell (colorimetric assays: Prussian blue assay, Ferrozine assay; ICP-MS; ferromagnetic resonance; magnetophoresis; MACS).
3- Assess the ability of cells to retain the label throughout several cell divisions (dilution effect).
I will be happy to share any additional information with you in relation to the aforementioned techniques that will be required to perform this set of experiments.
I would appreciate your response ASAP including a quote and available earliest start date for these studies.
You can reach me at your earliest convenience to my cell phone (Cell:+1-630-362-5835), via email: email@example.com, or
Looking forward to hear from you soon.
Many thanks in advance.
Pablo Gurman, MD
Gur &Gor LLC
Very Experienced, FDA certified Preclinical Contract Research Organization needed for in vivo preclinical studies for 2 phase subset of FDA biocompatibility testing of eye implants in rabbits (eye implants intended to be used for cataract surgery in human). The program includes: - intramuscular or subcutaneous implantation test for 4 weeks - 6 test and 6 control rabbit eyes minimum 6 test months We would need the full set of services including preparation of the detailed study plan according to the ISO standards (ISO 11979-5), performing testing in animals and preparation of the final study plan including statistics.Please specify preliminary pricing offer for the services?
Preclinical Contract Research Organization needed for analysisof serum for two metabolites: Rodent serum sample analysis for ethanol concentration as well as nicotine/cotinine levels. Our current study requires analysis of approximately 450 samples for each of the two metabolites.
Preclinical laboratory needed for gene enhanced cell therapy toxicology study in immunocompromised rats, cannulated jugular vein injection of gene enhanced cell therapy product. Standard 8 week toxicology study in 20 athmyic nude rats
-Deadline for report is November, require start date of mid-august