Contract Laboratory has received the following Biologics, Biosimiliars 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 Biologics, Biosimiliars Laboratories to perform their Biologics, Biosimiliars Testing, Analysis, Assays, Product Development, Scientific Research Experiments, Inspections, Certifications, and Engineering Projects. If you are a Biologics, Biosimiliars laboratory that would like more information on these Biologics, Biosimiliars projects, please visit our registration page or call toll us free 1-855-377-6821.
Bioanalytical laboratory needed for analytical chemistry and microbiology testing to support stability extension of hydrolyzed collagen used in medical devices including viscosity, clarity, color, ash, moisture, pH, SO2, chromium, lead, heavy metals, PCP, fluoride, protein, bulk density, total bacterial count, salmonella, e coli.
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.
Molecular Biology / Bioanalytical Laboratory needed for up to three university-based experiments involving human cell lines:
Experiment #1: Test up to 5 human cell lines (i.e. liver, kidney, etc...). Formalinize these cell lines in order to have a bank ready to be used. Then culture peripheral blood stem cells,apply the different formalin treated cells into the growth media, and determine what occurs. I am looking to determine if differentiation is stimulated toward the cell lines that were added. Is there inhibition or is there no reaction?
Experiment #2: Culture peripheral stem cells, add various growth factors (ex. neupogen), and determine if cell expansion is stimulated
Experiment #3: Growth of autologous stem cells on an autologous feeder layer (cells and feeder layer from the same patient). Looking to find what numbers of cells are achieved in a set time frame.
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.
Regenerative Medicine Company needs FDA GMP or GMP compliant bioanalytical laboratory for characterization studies on the residual antibiotic (aminoglycoside) content of various tissue products under development.Previous successful work in validating analytical methods per USP Q2(R1) a must.
Pharmaceuticals laboratory needed for biologic finish product testing (appearance, PH-value, osmolalitypolymer/Aggregate of HSA, Total protein content, Sterility, Endotoxin(LAL-Test), Biological Activity, Liquid particle count. It`s 4000 IU/ml.Please let us know the price, quantity and time of test (proforma)
Biosafety Level BSL-2 Laboratory needed for conducting research on oncolytic viruses based on HSV1, Herpes Simplex Virus. We are looking for services for titrating how much HSV1 virus is present in our samples (e.g. plaque assays) and/or assays measuring cytopathic affect of virus in samples (CPE). We can provide cell lines for these assays if needed. If possible, we would also like to provide cancer cell lines to use for testing after titration is done in a more common cell line (e.g. vero cells).
Bioanalytical Laboratory needed for monoclonal antibody testing according to EMA and FDA guidelines:
Testing of monoclonal antibody for effector function according
Testing of monoclonal antibody preparations for Fc gamma receptor interactions
Testing of monoclonal antibody preparations for FcRn interaction
Large Canadian pharmaceutical firm needs a contract lab for Raw Materials Testing for Sorbitol that can test for lead and nickel using an AA or ICP instrument. The specifications of the tests are lead, [EP (2.4.10) limit NMT 0.5ppm], and nickel [EP (2.4.15) limit NMT 1ppm]
GMP Compliant lab to perform the following: Full Monograph Testing (individual and total) for the following items:·,Magnesium Stearate·,Maltodextin·,Polyethylene Glycol·,Silicon Dioxide,·Stearic Acid·,Croscarmellose Sodium,,Dibasic Calcium Phosphate·,Lactose Monohydrate·, Specific Rotation for Ephedrine HCl·,Diphenhydramine HCl Organic Nitrogenous Bases for a pharmaceutical company
assess the androgenic activity, in a quantitative fashion, of a single steriod with the trivial name tetrahydrogestrinone(THG) in a pilot scale study. Either an aquatic organism model or rodent model would appear adequate to provide the information desired but other potential testing types will be considered such as in-vitro receptor binding studies. The study should compare the relative androgenicity of THG to a reference compound such as testosterone
Pharmaceutical Laboratory needed for Residual Moisture Content analysis (e.g. Karl-Fisher analysis ) on lyophilized cake. All excipients in the formulation safely handled under BL 1 conditions. Fast Turn Around Times a must. Laboratory should be in the contiguous United States.
Bioanalytical Laboratory needed for Vitamin detection on Fetal Bovine Serum. Following is a list of vitamins and detectable units:
Vitamin B-12 pg/mL
Folic Acid ng/mL
Vitamin B-6 ng/mL
Thiamin B-1 ng/mL
Vitamin H Biotin pg/mL
Riboflavin B2 ng/mL
Vitamin A Retinol ng/mL
Vitamin C ng/mL
Microbiology Laboratory needed for microbial analysis SB 3112. The test material consisted of only the bacterial spores at a count of 55 x 107 cfu/ml. The tests were run in compliance with the following protocols: 1 USEPA FIFRA;GLP Standards 40 CFR 160 2 USEPA TSCA 40 CFR 792 3 Org. Economic Coop. and Dev. Principles of GLP, Annex 2, C(97)186 4 Japan Ministry of Ag, Forestry & Fisheries, Notification No. 59 Noshan 3850, Director-General of Agricultural Prod. Bureau, 10 Aug 84
Preclinical toxicology laboratory needed for Cytotoxicity studies: MEM Elution Sample Amount: 120 cm2 or 4 grams Irritation: Intracutaneous Reactivity (ISO) (w/2 extracts) Sample Amount: 240 cm2 or 8 grams Sensitization: Magnusson-Kligman (w/2 extracts) Sample Amount 600 cm2 or 32 grams (6 samples minimum) Sensitization: Local Lymph Node Assay: Sample Amount 400 cm2 or 20 grams