Product and Services Finder
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Irvine Pharmaceutical Services Irvine Pharmaceutical Services is a market leader providing accurate and reliable chemical and microbiological results to the Pharmaceutical, Biotechnology and Medical Device industries in a timely and dependable manner....
ANALYTICAL DEVELOPMENT
Irvine’s analytical development group has experience in support of various dosage forms within the generic and branded pharmaceutical industries. The team’s...
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Metrics, Inc Metrics Inc. is a CDMO offering contract pharmaceutical research, pharmaceuticl 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...
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Triangle Research Labs, LLC. TRL produces high quality fresh and cryopreserved, human and animal, hepatocytes at the lowest prices.
ABC Transporter Products
Triangle Research Labs is a proud provider of GenoMembrane ATP-Binding Cassette (ABC) Transporter Membranes and Vesicles. These products are prepared from...
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Aragen Bioscience Aragen Bioscience offers cell line development, protein expression and purification, molecular biology, cell biology immunology, and diverse in vivo services to the biotech and pharmaceutical industries. Our corporate...
Cell Based Assays
Scientists at Aragen Bioscience have extensive experience in implementing cell based assays for determining mechanisms of action, evaluating potential...
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Compliance Insight, Inc. Specializing in hands-on FDA Regulatory and Quality Assurance consulting and training for pharmaceutical, medical device, clinical operations and biotechnology industries worldwide.
Services
At Compliance Insight, it is our belief that a pro-active solution works best. This sets the stage for long-term success. Our thorough evaluation...
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Pacific BioLabs (PBL) Pacific BioLabs is a contract research organization (CRO) offering testing and research support services to its clients in the medical device, pharm/biopharm, and other industries. Specializing in the biological sciences,...
BIOASSAYS
Pacific BioLabs has extensive experience in performing bioassays, including procedures to assess the safety of therapeutic toxins. Toxin testing is...
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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 Validation
Rapid assay development qualification procedures shorten your time from engagement to results. Cambridge Biomedical can develop an assay in different...
Biomarker Services
Whether you are developing biomarker assays for use in clinical trials, post-approval diagnostics/prognostics, or even phase four pharmacovigilance,...
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Pharmaceutical Validation Solutions, Inc. PVS offers comprehensive knowledge of current regulatory standards, practices and a unique awareness of enforcement policies and activities. Our principle goal is to assist food and drug manufacturers in assuring...
Validation Capabilities
Pharmaceutical Validation Solutions, Inc. has extensive experience in performing services for equipment, facilities, utilities, automation and processes in...
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BioSolutions At BioSolutions, we take validation, startup, and commissioning seriously. In the BioPharm industry, merely satisfying regulatory requirements rarely identifies all the weaknesses associated with a piece of equipment....
BioSolutions Edge
At BioSolutions, we take validation, startup, and commissioning seriously. In the BioPharm industry, merely satisfying regulatory requirements rarely...
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Analyse-it We formed Analyse-it back in 1997 to develop easy-to-use statistical analysis and charting software. Analyse-it®, our flagship product, was launched the same year.
Going back a few years, Analyse-it grew out of a product...
Analyse-it Method Evaluation Edition
Supporting the latest CLSI and industry-recognised protocols, Analyse-it lets you meet CLIA, CAP, JCAHO & ICH-Q2A/B analytical method validation...
Analyse-it Standard Edition
Building on the industry-standard spreadsheet, Analyse-it integrates into Microsoft Excel to provide you with a wide-range of statistics and charts for...
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Domainex Domainex is a drug discovery company with a reputation for speed and innovation built on an exceptional track record of drug candidate delivery. It has a world class discovery team with an unrivalled track record of 5...
Assay Development
Domainex is able to support its clients with biochemical assays, as a component of integrated drug discovery projects, where we are also providing medicinal...
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IntelligentMDx The fundamental distinction between traditional assay design and those designed at IMDx lies in our unique, proprietary bioinformatics platform, NGENix™, which uses streamlined in silico modeling to design and develop...
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Assay Validation
Research Library
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ImmunoSite Technologies, LLC
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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 ...
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Compliance Insight, Inc.
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5850 Boymel Drive, Suite 1 Fairfield, OH 45039 Tel.: 513.860.3512 Fax: 513.860.3406 www.compliance-insight.com
AUDITING THE VIRAL CLEARANCE TESTING LABORATORY
Written by: Jeri Ann Boose, Ph.D., and Michelle Arvoy Compliance Insight, Inc.
This paper outlines the key elements that should be evaluated during a pre-qualification viral clearance audit. Development of this outline was based upon ...
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Aragen Bioscience
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Monoclonal antibodies (mAbs) are one of the fastest growing classes of protein therapeutics. For many antibodies, the
N-glycosylation status of the Fc region of the H-chain plays a significant role in the therapeutic function. The structure and
extent of heterogeneity of these N-glycans are two of the distinguishing features in selecting a protein expression platform
for a therapeutic antibody.
A ...
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Compliance Insight, Inc.
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5850 Boymel Drive, Suite 1 Fairfield, OH 45039 Tel.: 513.860.3512 Fax: 513.860.3406 www.compliance-insight.com
Written by: Michelle Arvoy, Cynthia Ipach, and Jeri Ann Boose, Ph.D. Compliance Insight, Inc.
Viral Testing and Viral Clearance Studies are expensive and time consuming aspects of pharmaceutical manufacturing. Various types of control must be considered during planning and performance ...
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Compliance Insight, Inc.
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5850 Boymel Drive, Suite 1 Fairfield, OH 45039 Tel.: 513.860.3512 Fax: 513.860.3406 www.compliance-insight.com
Written by: Michael Goodman Compliance Insight, Inc.
A sponsored Process Validation Q &A Understanding FDA’s guidance and what it discussion means for your company
The new guidance updates FDA’s original 1987 think- ing on process validation in Current Good Manufacturing ...
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