This document provides an overview of bioanalytical and biotechnology services including small and large molecule analysis for discovery, pre-clinical, and clinical studies using various platforms such as LC/MS, MSD, and Luminex. Specialized services include peptide, protein, and oligonucleotide analysis from tissues as well as immunogenicity and cell-based assays. What makes the services unique are their method development experience, single point of contact, timely communications, regulatory track record, extensive automation, metrics on milestones, and backing from LabCorp.
4. What makes us unique?
• Method Development Experience
• Single point of contact
• Timely communications to fit your schedule
• Regulatory track record
• Extensive automation
• Metrics on critical milestones
• Backed by LabCorp (NYSE:LH)
Editor's Notes
Hi I’m Renee Louis – I am the business development director for Tandem Labs in the Bay Area. We are excited to be here as a major Sponsor.Tandem Labs has been focused on Bioanalytical services for over 30 years. We have four sites across the US with a wide breadth of expertise. Our San Diego and New Jersey sites provide support for large molecules and our Salt Lake, RTP, and New Jersey sites provide Mass Spec based support. As you can see, we have two sites that are an easy day trip from this area.We continue to have significant growth both internally and by acquisitions, most recently was MedTox. This was carefully evaluated and if you know them, know that they have an extensive list of NPA’s that adds to our existing list. Today I would like to take this opportunity to discuss our services and capabilities.
Some Key Points about our Bioanalytical and Biotechnology ServicesRapid Method Development - we have a lot of experience with many compounds including some very difficult onesCollectively we have developed over 250 GLP methods in the past yearWe have an extensive list of Non-proprietary Assays with great coverage in several therapeutic areas including CNS, Oncology, Antiviral, Asthma, and COPD enabling us to support DDI studies.>300 studies supported in 2011 across our sitesPharmacokinetic Assays, Immunogenicity / Cell-Based Assays, Biomarker AssaysQuantitative or semi-quantitative immunoassays for the measurement of endogenous compoundsMSD, ELISA, RIAMultiplexed assay development, validation, and sample analysis utilizing Bio-Plex and MSD
We offer unique areas supporting new areas of growth to support our Sponsors. We have successfully worked with single and double stranded DNA, siRNATissues: Ocular, skin, toenails (std – brain, liver, lung, kidney) – we have automated the processAlthough we have provided ImmunoAssays for a long time, we have had to specialize our services to meet our Sponsors needs.
Senior PMs & PhD level Scientists acting as your single point of contactThe scientists are active in the community; papers, posters, presentations, and supporting the organizations keeping them up to date Timely communications to fit your scheduleRegulatory strength – 10 FDA audits, all data has been acceptable to the agencyExtensive automation – liquid handling (Hamiltons at all sites) and sample homogenization.Metrics on critical milestones – ensures on-time deliverablesBacked by LabCorp (NYSE:LH) – transparent financials, very committed to Clinical Trials and Tandem. This has allowed us to make key purchases, including additional lab suites to two of our sites.Tandem provides focused support from early discovery through PhIV – that combined with our expertise has resulted in long term relationships and high quality, robust methods and data.For more detailed information, please stop by our table top during one of the breaks. Thank you!
