Product and Services Finder

Assay Development

    
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AAIPharma Services Corp.  AAIPharma's offerings include analytical development, formulation development, oral solid dose and parenteral manufacturing, pharmaceutical packaging, stability storage and analytical testing services.
 
Biotechnology AAIPharma Services provides customers with a broad range of biotech analytical services. We have extensive analysis capabilities across structural chemistry...
NDI ADRL Inc. dba Diteba  Diteba is a development and testing laboratory that provides GMP analytical and GLP bioanalytical testing services from pre-clinical to Phase IV testing from method development and validation to QC Release, In Vitro...
 
Analytical Chemistry Services Analytical Services, Outsourcing Services
 
Bioanalytical Testing Services Bioanalytical Services, Outsourcing Services
 
EMD Millipore Bioscience  The Bioscience portfolio delivers products & services for life science research in academic & pharmaceutical environments. Our focus on genomic, proteomic & cellular analysis is supported by sample preparation, research...
 
MMP-9 Immunoassay Kit, proform only Clonality: Gene ID: NM_002424.1 Host Name: Cross-reactivity: Human Only Type:
 
TIMP-1 Immunoassay Kit, measures Free Plus Complexed TIMP-1 Clonality: Gene ID: NM_003254.2 Host Name: Cross-reactivity: Human Only Type:
BASi - Bioanalytical Systems, Inc.  bioanalytical sample analysis automated in-vivo blood sampling toxicology pharmaceutical analysis electrochemistry EC liquid chromatography LC Vetronics
 
Bioanalytical Method Development and Sample Analysis Contract Services BASi offers high capacity GLP/GCP bioanalysis and fast sample analysis turnaround. We have more than 30 years experience providing contract laboratory...
 
Large Molecule Bioanalytical Services BASi continues to expand its bioanalytical services in the area of large molecule bioanalysis; protein-based and oligonucleotide-based therapeutics. BASi...
 
JHP Pharmaceuticals  JHP Pharmaceuticals’ Rochester, Michigan facility (www.jhppharma.com) has been providing contract manufacturing services for sterile injectables for over 25 years. JHP’s cGMP-compliant manufacturer • An established...
 
Clinical & Commercial Aseptic Fill & Finish JHP has the capabilities and capacity to manufacture small-scale clinical or large-scale commercial products. We have multiple high-speed filling lines that...
ImmunoSite Technologies, LLC  Contract Research Services provider of assay automation and product development for the Life Sciences, and particle testing for manufacturing QC.
 
Assay Automation Services For when you have to do more with less by yesterday!
LI-COR Biosciences  LI-COR Biosciences’ near-infrared fluorescent and chemiluminescent imaging systems, reagents and accessories are ideal for today’s cancer research. Includes Odyssey, Odyssey Fc, Pearl, 4300 DNA Analyzer, BrightSite...
 
1 Multiwell-Plate Alignment Guide - Odyssey Accessory Suitable for aligning a multiwell plate on the glass surface of the Odyssey Classic or Odyssey CLx Imaging System. Odyssey CLx Infrared Imaging System (PN...
 
6 Multiwell-Plate Alignment Guide - Odyssey Accessory Suitable for aligning up to 6 multiwell plates on the glass surface of the Odyssey Classic or Odyssey CLx Imaging System. Odyssey CLx Infrared Imaging...
 
Confluence Discovery Technologies, Inc.  Confluence is a Contract Research Organization providing Clients with 125+ Years of Drug R&D know-how and a proven track record having delivered 29 Phase I and 21 Phase II drug programs that resulted in 4 marketed...
 
Cell & Molecular Biology meeting drug target & biomarker requirements
 
Custom Assay Development when “OFF the SHELF” is not an option
 
Metrics, Inc  Metrics Inc. is a CDMO offering contract pharmaceutical research, pharmaceutical development, clinical trial and commercial manufacturing services. Metrics provides FTIM development and Phase I, II and III CTM.
 
Formulations Development Metrics provides pharmaceutical product development including pre-formulation studies, formulation development, Clinical trial batch manufacturing and...
Myriad RBM, Inc.  Myriad RBM is a CLIA-certified biomarker testing laboratory specializing in cost-effective, high-quality multiplexing services. Our protein immunoassays benefit drug discovery & development from preclinical through Phase...
 
Assay Development Development and validation of multiplexed immunoassays is a core competence at RBM. Commercially available antigens and antibodies are screened for their...
 
Services Provided Myriad RBM, Inc. is the world’s leading multiplexed immunoassay testing laboratory, providing comprehensive protein biomarker services based on its...
 
Creative Diagnostics  Anti-Hapten; Antibody against Membrane Protein; Lateral flow; hybridoma monoclonal antibody; ELISA; Assay development;
 
Colloidal Gold Lateral Flow Strips Development Creative Diagnostics offers extensive experience in the development of rapid, point-of-care, lateral-flow-format diagnostic assays. We can fully develop...
 
ELISA Assays Creative Diagnostics provides contract ELISA development kit services for the R&D and IVD community. We conduct ELISA kit development services for...
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.
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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.

Read the full product review



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

Methods for the Determination of Protein-Ligand Binding Constants
NDI ADRL Inc. dba Diteba
How to Create a Valuable Testing Approaches for prtotein-ligand interactions. The non-covalent binding of small molecules, ligands to proteins or proteins to proteins, plays a crucial role in biopharmaceutical research. This interaction can alter the stereochemistry of a protein molecule (a drug candidate) and also could modify its molecular recognition ability and ultimately its bioactivity. ...
 
On-site Staffing for Analytical Testing Prevents Regulatory Sanctions and Product Market Disruption
AAIPharma Services Corp.
On-site Staffing for Analytical Testing Prevents Regulatory Sanctions and Product Market Disruption Challenge Regulatory commitments and shifting product lines for a pharmaceutical company put product market supply at risk and presented a high probability of regulatory sanctions. The situation created a critical, accelerated demand for GMP-compliant analytical testing. Solution AAIPharma ...
 
Standardized Functional Cell-Based Immune Response Assays in Vaccine and Biologic R&D
ImmunoSite Technologies, LLC
The identification and application of correlates of immune response can enable significant time and money savings especially in clinical trial settings for vaccine and biologic R&D. Functional cell-mediated immune response assays have been used as readouts · To evaluate efficacy of vaccines and therapeutic strategies for infectious diseases and cancer · To identify and characterize the undesired ...
 
Determination of an Acceptable Preservative for...
BASi - Bioanalytical Systems, Inc.
This method uses a 50:50 THF:water extraction solvent for the preparation of standards and samples. Preservative at a level of 0.1 weight percent in solution was added to stabilize the preparations. Analysis was accomplished by HPLC carried out on a Phenomenex Luna Phenyl Hexyl (150 x 4.6 mm) column at a flow rate of 1.0 mL/min. The separation was completed with a mobile phase of 35 mM ...
 
Complete Sample Protocol Detailing Seeding Stimulation, and Detection of the HeLa Cellular Response to Epidermal Growth Factor
LI-COR Biosciences
In-Cell Western Assay protocol for the quantitative determination ERK phosphorylation in HeLa cells in response to EGF stimulation.
 

Assay Development Video

AAIPharma Overview AAIPharma Services Corp.
 
EMD Millipore Overview EMD Millipore Bioscience EMD Millipore is a leading supplier in the life sciences industry with over 60,000 products, tools and technologies on the market. We provide ...
 
Assay Development NDI ADRL Inc. dba Diteba Information

Assay Development News

Assay Development Metrics, Inc Information
Assay Development ImmunoSite Technologies, LLC Information
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