Contract Laboratory has received the following incoming 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 Register Laboratories or call toll free 1-855-377-6821.
Clinical research laboratory needed for preclinical studies of the effect of a novel molecule in treating the delay in process of myelination. Study to include toxicology, immunology, as well as hematological studies relating to the process of coagulation and fibrinolysis.
FDA GMP Pharmaceutical bioanalytical laboratory needed for heparin testing for determination of Anti Factor IIa activity on heparin sodium API samples according to EP 9.2, monograph 01/2017:0333
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
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 3. Cytomegalovirus 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