Contract Laboratory has received the following Pharmaceuticals and Biopharmaceuticals 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 Pharmaceuticals and Biopharmaceuticals Laboratories to perform their Pharmaceuticals and Biopharmaceuticals Testing, Analysis, Assays, Product Development, Scientific Research Experiments, Inspections, Certifications, and Engineering Projects. If you are a Pharmaceuticals and Biopharmaceuticals laboratory that would like more information on these Pharmaceuticals and Biopharmaceuticals projects, please visit our registration page or call toll us free 1-855-377-6821.
Test Request 17-01798
FDA cGMP/ ISO 17025 Pharmaceutical Microbiology Laboratory needed for USP monograph, stability and compliance testing of sterile and non-sterile compounded pharmaceuticals to 21 CFR parts 210 and 211, the Compounding Quality Act and USP <797> for sterile and <795>.for non-sterile. . Laboratory must have validated potency method for APIs. including : o 201070 BENZOCAINE 20% / LIDOCAINE 10% / TETRACAINE 10% EMULSION CREAM o 201010 BENZOCAINE 20% / LIDOCAINE 10% / TETRACAINE 10% EMULSION o 201020 LIDOCAINE 23% / TETRACAINE 7% CREAM o 011021 NIACINAMIDE 4% / TRETINOIN 0.05% CREAM o 011013 NIACINAMIDE 4% / TRETINOIN 0.025% CREAM ? For microbial/ yeast/mold and endotoxin testing they must have a rapid scan method)
Test Request 17-01778
Pharmaceutical Analytical Chemistry Laboratory needed for conducting studies on the Active Pharmaceutical Ingredients APIs in an oil in water emulsion. We need to arrive at following conclusions by morphological/physical/chemical testing etc
1. Whether APIs are dispersed or solubilized (both APIs).
2. Phase in which each API is present (dispersed phase of emulsion or continuous phase of emulsion)
3. Particle size of API (for dispersed API). Separate PSD for each API if both are dispersed.
4. Globule size of emulsion.
Test Request 17-01753
LONG-TERM TESTING Microbiology Laboratory needed for MIC testing of pharmaceutical test articles with or without 5% Fetal Bovine Serum (FBS) with the following test organisms:
1. S.Aureus ATCC 29213
2. S. Aureus 33591
3. P. Aeruginosa ATCC 27853
4. P. Aeruginosa 1674623
Test Articles: Collodial Ag nanoparticles + Zinc citrate in sterile water suspension. We will supply all test articles.
1. Ag 30 ppm
2. Ag 100 ppm
3.Ag + Zn at 30 ppm each
4. Ag+ Zn at 100 ppm each
5. Ag at 30 ppm and Zn at 2000 ppm
6. Ag at 100 ppm and Zn at 2000 ppm
7. Citrate (vehicle control)
8. Ciprofloxacin (positive control)
Test Request 17-01734
Test Request 17-01681
Healthcare manufacturer needs Microbiology Laboratory for Bacterial Suspension Testing using P. aeruginosa. Specifications are: Suspensions diluted to 10^-6 and 10^-7 in sterile saline, pour plated in 0.2 ml amounts in Trypticase Soy Agar and incubated 24-48 hours at 33C to 37C. T0: 4.3 x 10^7 -- 7.6 x 10^8 CFU/ml
T6: 4.6 x 10^7 -- 7.6 x 10^8 CFU/ml
Test Request 17-01679
LONG-TERM TESTING Small business that manufactures topical homeopathics in small batches needs microbiology laboratory for USP Batch Testing to USP Standards: USP 61 MICROBIOLOGICAL EXAMINATION OF NONSTERILE
PRODUCTS: MICROBIAL ENUMERATION TESTS
and/or USP 62 MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: TESTS FOR SPECIFIED
Test Request 17-01640
University researcher needs pharmaceutical microbiology laboratory for testing two drugs alone and in combination as part of a Minimum inhibitory concentration (MIC) study against the following microbes:
Test Request 17-01632
FDA registered and cGMP compliant analytical chemistry laboratory needed for latex and/or DEHP (Di Ethyl Hydroxy Phthalate) testing on rubber closures (stoppers) or syringe pistons used for injectable pharmaceuticals. We are not currently looking for a full extractable/leachable study, just the ability to test for the specific items.
Test Request 17-01622
Skincare company needs dermatology clinical research laboratory for development of a protective cream for prolonged work in gloves that helps avoid excessive sweating on the skin of hands, restrains the growth of harmful microorganisms (bacteriostatic effect), and improves microcirculation in the vessels of the skin of hands, protects cells from harmful factors. This product has 3 main properties, which need to be confirmed: 1) Antiperspirant effect 2) Improvement of cutaneous respiration 3) Bacteriostatic effect We are planning to register this product as a cosmetic product. So we have to confirm these claims with test reports by 1) Antiperspirant effect was confirmed by gravimetric method and method the probe of Minor (iodine-starch test). The effect of the product was shown to be lasting up to 4 hours. 2) Skin respiration (cutaneous respiration) is the property, which includes all kinds of exchange processes in the skin (supplying the skin with oxygen), metabolic processes (synthesis of collagen and elastin), regeneration processes and improving the viability of the skin cells when exposed to harmful environmental factors. These properties are provided by the 2 components of product (caffeine and ginger extract) increasing ATP synthesis in the cell (under the influence of acetylglutamine), as well as the microcirculation in the skin. The effect of product to improve cutaneous respiration was confirmed by laser Doppler flowmetry. 3) Bacteriostatic effect the temporary suppression of the ability of microorganisms to reproduce (not the same as antibacterial action!). This effect is side-effect, because the composition of the product contains no antibacterial ingredients. The effect is achieved by the common action of the antiperspirant complex.
Test Request 17-01583
Microbiology laboratory needed to run BACTEC blood culture incubation on a variety of blood samples inoculated with different strains and concentrations of Staphylococcus aureus. Our design would necessitate approximately 30-40 samples be run. We are interested in time to threshold of detection and which samples do not reach threshold at 5 days.
Test Request 17-01578
Contract Research Organization CRO needed to test the activity of microglial engulfment via TEM of debris of dead neuron and oligodendrocytes in the corpus callosum of mice as in fig 2 of the J Clin Invest. 2015;125(5):2161?2170. doi:10.1172/JCI77983 paper
Test Request 17-01571
University researcher needs laboratory to perform in-vitro study of antiulcer activity of plant extract according to the methodology methodology is Inhibition of Histamine stimulated Adenylate cyclase from gastric mucosa using guinea pigs. The in vitro potencies of H2-antagonists can be evaluated using determinations of adenylate cyclase activity in membrane preparations of guinea pig mucosa after stimulation with histamine. Reference: Drug Discovery and Evaluation, by H. G Vogel, pg. no. 861
Test Request 17-01518
Virology laboratory needed for performing PCR analysis for many different rabbit and porcine viruses based on the guideline (CPMP_BWP_3354_99), as follows. CPMP_BWP_3354_99: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003222.pdf:
For rabbit viruses: Rabbit rotavirus, Reovirus type 3, Poxviruses, Rabbitpox (RPXV), Myxomatosis virus (MYXV), Shope fibroma virus, Rabbit haemorrhagic disease virus (RHDV), Rabbit papillomaviruses, Rabbit kidney vacuolating virus, Herpes cuniculi Adenovirus, Encephalomyocarditis virus, Borna disease virus, Sendai virus, Simian Parainfluenza (SV-5), Pneumonia virus of mouse (PVM).
For porcine viruses: Enveloped Viruses, Influenza virus A (,airborne), Nipah Virus & Menagnel Virus (paramyxoviruses), Vesicular Stomatitis Virus (aerosols), Pseudorabiesvirus (dsDNA, traumatic inoculation), Rabies virus (ssRNA, bite), West Nile virus(mosquito bite), Hantavirus (Rodent-borne), Eastern equine encephalomyelitis (mosquito bite) Non Enveloped Viruses, Swine Hepatitis E virus HEV(33 nm, RNA, fecal-oral), Encephalomyocarditis virus EMCV(28 nm RNA, oral), Swine Vesicular Disease Virus SVDV/PEV9 ( oral), Foot and mouth diseases virus FMDV (28nm, RNA, airborne), Reo/Rota virus (oral).
Test Request 17-01360