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Assay Development

    
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The Jackson Laboratory  We discover precise genomic solutions for disease and empower the global biomedical community in our shared quest to improve human health. We offer an array of scientific products and services to meet your research needs.
 
Jackson Laboratory Services We are an independent, nonprofit organization focusing on mammalian genetics research to advance human health. Our mission is to discover the genetic basis...
Fujirebio Europe (formerly Innogenetics)  Fujirebio is a leading international healthcare company with a strong focus on high quality in vitro diagnostics testing solutions.
 
AutoBlot 3000 AutoBlot 3000 offers fully automated processing of INNO-LIA tests from sample incubation to color development, ensuring ease of use, speed, and confidence.
 
AutoBlot 3000H AutoBlot 3000H offers fully automated processing of selected INNO-LiPA and INNO-LIA™ tests* from hybridization to color development, ensuring ease of use,...
 
Rockland Immunochemicals, Inc.  Rockland is a manufacturer of antibodies, producer of blood products and cell cultures and custom antibody development partner.
 
Custom Monoclonal Antibody Production Rockland’s custom antibody production services allow you to direct the generation of your research required antibody. Let Rockland’s expertise aid you in...
WuXi AppTec  Leading outsourcing company for pharmaceutical, biologics, and medical device with operations in China and the US; Biopharmaceutical, Pharmaceutical Discovery & Development, Toxicology, Bioanalytical, GMP Manufacturing,...
 
Assay Development WuXi AppTec's discovery biology services, which are part of our integrated pharmaceutical services, include reagent generation, assay development,...
 
Reagent Generation WuXi AppTec's discovery biology services, which are part of our integrated pharmaceutical services, include reagent generation, assay development,...
Creative Diagnostics  Anti-Hapten; Antibody against Membrane Protein; Lateral flow; hybridoma monoclonal antibody; ELISA; Assay development;
Cambridge Biomedical  Cambridge Biomedical is an analytical contract laboratory that works with biotechnology, pharmaceutical and reference laboratories. We specialize in assay development, qualification, validation and sample testing.
 
Assay Development Rapid assay development qualification procedures shorten your time from engagement to results.
 
Biomarker Services Whether you are developing biomarker assays for use in clinical trials, post-approval diagnostics/prognostics, or even phase four pharmacovigilance,...
 
Capra Science Antibodies AB  Capra Science provides custom antibody services; poly- and monoclonal antibody generation and production, peptide-specific antibodies, purifications, humanization of antibodies and assay development.
Embark Scientific  Embark Scientific provides Clinical and Pre-clinical Assay Development, High throughput Sample Processing, Laboratory Animal Genetics, mouse genotyping and Health Monitoring, Research-based development and testing...
 
Assay Development Our Design & Development Services provides a quick and affordable way to bring new assays online without impacting your staff or equipment resources. ...
BioInvenu Corporation  BioInvenu provides sensitive and cost-effective assay products including GPCR (7 transmembrane receptor), nuclear receptor, & receptor tyrosine kinase assay cell lines, and services including custom assay development and...
 
GPCR b-arrestin assay cells GPCR b-arrestin assays
 
Kinase signaling pathway Linklight assay cells Kinase signaling pathway assays assess specific kinase substrate/effector and its binding partner interactions based on LinkLight technology
 
Haemtech Biopharma Services  Offering biopharmaceutical stability studies, release testing, immunogenicity assay development, and contract reagent manufacturing.
 
Assay Development We can develop, qualify and validate an ELISA assay specific to your needs. Choose from our menu of antigens and antibodies, supply your own or we can work...
 
Assay Services We can develop, qualify and validate an ELISA assay specific to your needs. Choose from our menu of antigens and antibodies, supply your own or we can work...
 
Fluofarma  Specialized in high-content analysis (HCA), assay development and biomarker analysis, Fluofarma delivers custom preclinical CRO services in drug discovery.
 
Services Fluofarma supports the discovery of new therapeutic targets, compounds and biomarkers. Combining in-house capacities in cell biology and high-content...
SDIX  antibody development, antibody production, monoclonal antibody, polyclonal antibodies, critical reagents, assay development, immunoassay development, antigen design, genomic antibody technology, GAT, genomic antibodies,...
 
Antibody Development When it comes to needing an antibody that will work for your research, diagnostic or drug discovery - talk to the scientists at SDIX. We ask the right...
 
Assay Development We bring that level of expertise to you in helping you decide on the right antibody development and screening method for your particular application. We...
Assay Depot  Assay Depot operates the world’s largest online marketplace for drug discovery research services. Researchers use the marketplace to find, compare and purchase research services and to request information from thousands...
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Assay Development - Product Reviews

Lancaster Laboratories – Cell bank manufacturing
Jeff Kelly, Online Industry Editor

Lancaster Laboratories offers cell bank manufacturing services, including manufacturing, storing and characterizing mammalian cell banks like master, working and research banks and expertise in cold-chain management. Its manufacturing facility is cGMP-compliant and includes multiple ISO 7 clean rooms and ISO 5 critical areas that are compliant with aseptic processing guidelines. Lancaster Laboratories also offers fully validated manufacturing procedures including process simulation studies to insure manufacturing process integrity.

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Innovative approach to Phase I and Phase II clinical trials cuts both time and cost

The accelerated proof-of-concept (AcPOC) study design streamlines clinical trial work by combining four studies into a single integrated solution.  In a study on an allergy treatment, POC studies were combined with single ascending dose (SAD), multiple ascending dose (MAD) and preliminary food effect studies, all of which require the development of assays to measure concentration of the drug in the blood of the study participants. Running these four studies sequentially can take up to 28 to 36 weeks, while an AcPOC study can be conducted in 14 to 18 weeks.

“There is tremendous pressure on pharmaceutical and biotech companies to save money while still providing safe and effective treatments. The accelerated proof-of-concept design helps assess drug candidates more quickly and at less cost,” said Dr. Troy McCall, CEO of Cetero Research. “For small and mid-sized firms, the need to establish POC is essential in securing financing or hitting the next milestone payment.”

“Organizations can see huge savings in the amount of staff training time and time to implement the study when they use the AcPOC approach,” said Dr. Graham Wood, President of Clinical Operations for Cetero’s Toronto and Miami facilities. While AcPOC can be used for a variety of therapeutic studies, different areas necessitate the integration of different study types. Therefore, both time and financial savings will differ from study to study.


Best-in-Class Patient Assay Development Providers:

  • Run positive and negative reference controls in replicates of 8-16 in wells on the outside columns of the microtitre plates.
  • Use plates that all have positive and negative reference controls.
  • Run compounds in primary screens in singlets only.


Top Considerations Before Selecting Assay Development Provider:

Characterization of the stability of the assay reagents is very important and some regulatory inspections have uncovered deficiencies in this area. The manufacturer’s quality control (QC) group usually performs the task of characterization, which should include assessments of the compound identity, the purity, the concentration or titer of the material, the storage conditions and the expiration date. Check to make sure that potential assay development providers use adequately characterized standard assay reagent reference material with appropriate documentation.

Key Producers:

1. Rules-Based Medicine (RBM) , a CLIA-certified biomarker testing laboratory, has developed a proprietary Multi-Analyte Profile (MAP) platform to provide reproducible, quantitative multiplexed immunoassay data for hundreds of proteins. In order to achieve the sensitivity and dynamic range necessary to quantify the target analyte, each assay is first developed as a single-plex test and then the resulting single-plex assays are aggregated. Validation of these multiplexed assays with a battery of analytical procedures completes the development process. RBM also offers therapeutic-specific MAPs custom designed for late-stage clinical development. Corporate headquarters and biomarker testing laboratory are in Austin, TX; multiplex assay development and manufacturing is in Lake Placid, NY and a wholly owned subsidiary is in Germany.

2. Brighter Ideas, Inc.'s “GFP-on-a-String” is a proprietary biomedical test for proteases and protease inhibitors using green fluorescent protein (GFP). With highly specific protease tests, which measure only one protease type or class, often dozens of separate assays have to be run in order to identify an unknown protease. Bii reports that "GoaS automatically, in one, very high sensitivity test, measures any protease present in the sample while providing a precise identification of that protease with respect to a large electronic data base. No other protease assay does this sort of 'fingerprinting'." Bii, founded in 2003, focuses on advancing fluorescent protein technology through research and by offering educational programs. This company is located in Metuchen, NJ.

3. The Jackson Laboratory’s JAX® Mouse Diversity Genotyping Array Service is based on its proprietary high-resolution genotyping array, which enables high-density, genome-wide profiling of single nucleotide polymorphisms (SNPs). This array covers 100 times more SNPs than any other available mouse array and can simultaneously assay over 620,000 phylogenetically informative SNPs for the characterization or comparison of mouse DNA samples. In addition to conducting genetic research into ways to prevent cancer as well as to discover drugs to treat conditions including: cancer, diabetes, Alzheimer’s and cardiovascular disease, this independent, nonprofit organization provides scientific resources, techniques, software, data and mice colonies for test animals to scientists in research institutions and laboratories around the world. The Jackson Laboratory is an NCI-designated Cancer Center with facilities in Maine and California.

4. Cetero Research offers a large portfolio of assays as well as services for bioanalytical clinical trials. Cetero’s bioanalytical services support clinical, preclinical drug and biomarker analysis for small and large molecules. This company reports that “Our 50 instruments offer substantial capacity to analyze your samples…in a high-throughput environment to meet the most demanding schedules.” Cetero Research has two state-of-the-art facilities in Houston TX and Toronto, Canada. The Toronto facility offers organic synthesis capabilities for synthesizing metabolites. Its bioanalytical labs use InnaPhase's Watson™ Laboratory Information Management System (LIMS) for laboratory control and report writing. This company was formed in 2006 and 2007 by the merger of five research companies that had all been in business since the 1980s.

Assay Development
Definition: An assay is a procedure for measuring a process, like enzyme activity, antigen capture, stem cell activity and competitive protein binding, or the amount of a drug or biochemical in an organism or organic sample.

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Assay Development Research Library

MBS Assay Development Services
Maine Biotechnology Services
MBS announces the expansion of contract services offered to include ELISA development. The assay development service will provide customers with refined, R&D use assays at the end of hybridoma development. Optimization of reagents for assay applications has long been an area of core competency for MBS, used heavily in the development of internal products and services. It is with great excitement ...
 
CASE STUDY: BIOMARKER ASSAY DEVELOPMENT, VALIDATION & IMPLEMENTATION
Confluence Discovery Technologies, Inc.
CASE STUDY: BIOMARKER ASSAY DEVELOPMENT, VALIDATION & IMPLEMENTATION CONLFUENCE DISCOVERY TECHNOLOGIES | CASE STUDY An assay was developed, validated and utilized in a clinical study to determine the activation of “Kinase 1” in human feces as a biomarker of colonic inflammation resulting from infection. Kinase 1 phosphorylates Substrate 1, which in turn phosphorylates Substrate 2, both of ...
 
Gyros Gyrolab™immunoassay and ligand-binding assay platform.
MPI Research
MPI Research is pleased to announce its acquisition of the Gyros Gyrolab™immunoassay and ligand-binding assay platform. The Gyrolab is known for its high level of accuracy, rapid method development and validation, and delivery of robust assays. This gives our Sponsors a competitive advantage with their pharmacokinetics, anti-drug antibody, and host-cell protein (HCP) testing. Time for assay ...
 
Recent Science at MPI Research
MPI Research
MPI Research recently hosted a series of scientific sessions at the 50th Society of Toxicology meeting in Washington, D.C., and we thought that you might enjoy the opportunity to view these presentations. We hope that you will find them to be valuable in your own scientific development. HYPERLINK "http://cts.vresp.com/c/?MPIResearch/169 8c590ad/fe3a75a144/8125f4957a/page_id=26 31" Logistic and ...
 
Labeling of Fixed Cells with IRDye® NHS Ester Reactive Dyes for In-Cell Western™ Assay Normalization
LI-COR Biosciences
The In-Cell Western™ assay is a popular immunoassay for the study of signal transduction, pro- tein expression and function. A key feature in this assay is its ability to simultaneously measure two targets of interest or normalize the data for well-to-well variation in cell number. LI-COR® has developed three types of protocols for normalization. 1. The first method uses primary and secondary ...
 

Assay Development Video

Jackson Laboratory's legacy of genetic discovery The Jackson Laboratory The Jackson Laboratory has been a significant force in genetic discovery for more than 80 years. We discover the genetic basis for preventing, treating ...
 
In-Cell Western™ Assay Applications: Cell Proliferation, RNAi Screens, Receptor Trafficking. LI-COR Biosciences
 
Assay Development Fujirebio Europe (formerly Innogenetics) Pharmaceuticals

Assay Development News

Assay Development Rockland Immunochemicals, Inc. Pharmaceuticals
Assay Development Wockhardt Products
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