CA 92121 USA
1 (858) 558-2599
With over 20 years of experience Intertek Pharmaceutical Services conduct regulated bioanalytical studies through state-of-the-art, Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) compliant laboratories supporting the development of pharmaceuticals, biopharmaceuticals, vaccines and biosimilars for clients around the world.
Intertek’s Bioanalysis scientists have worked with thousands of different compounds providing phase appropriate small molecule bioanalysis, large molecule bioanalysis, immunogenicity assays and biomarker studies. Our teams are adept in method development and validation of efficient and accurate methods suitable for your compound whilst addressing matrix interferences across a diverse array of biological matrices including plasma, blood, serum, urine, faeces, spinal fluid, skin, ocular tissues, muscle, artery, myocardium, liver and kidney and a variety of tumour types. With a focus on the evolving guidance our bioanalysis thought-leaders design programs to generate regulatory driven bioanalytical data to help you meet your next milestone. From our centres of excellence in North America (San Diego, California, USA) and Europe (Manchester, UK) our teams have worked to generate data for submissions in all global market regions.
Services include: Lead Optimization Studies, Bioequivalence and Bioavailability Studies, Pharmacokinetic Assays Method Development and Validation, LC/MS/MS Bioanalytical Services, Immunogenicity Assays, Biomarkers Assays and Validation Cell-Based Neutralization Assays, Ligand-Binding Assays, Clinical Kit Preparation, Sample Handling and Management, GCP Bioanalytical Services, Bioanalysis of PEGylated and other Polymer-Linked Drug Assays, Specialist services for Biosimilars, Antibodies, Antibody-Drug Conjugates and Vaccines.
Bioanalytical Technologies: Our innovative use of bioanalytical technologies such as quantitative LC-MS/MS and immunochemistry and a range of advanced techniques such as LC-MS/MS and NMR for large molecules means that no matter how complex your samples are, we can accommodate them.
GMP services: CMC support services for both small molecule and large molecules including; GMP Cell Based Assays, Analytical and Formulation Development, Stability Studies, Extractables / Leachables, QC Testing, GMP Batch Release, Method Development and Validation
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Impact of Recent Changes to FDA Immunogenicity Draft GuidanceIntertek will be presenting at the 67th ASMS Conference on Mass Spectrometry and Allied Topics (ASMS)
June 2-6, 2019
Wednesday, June 5 ASMS Poster Sessions: TBD
Presenter: Mike Buonarati
Enzyme Activity Assay of an Engineered Human Hoocyst(e)inase in Mammalian Serum using LC-MS/MS
Presenter: Larry Brill
Evaluation of nSMOL methodology for the Analysis of the mAB Bevacizumab in Human Plasma by LC-MS/MS
Presenter: Dale Schoener
LC-MS/MS with In-Source Collision Induced Dissociation for Direct Measurement of the 21 kDa Dendrimer Prodrug OP-101 in Human Urine
Come visit Intertek at Booth 1847 while at CPhI North America in Chicago, IL on April 30 – May 2
Intertek will be exhibiting and presenting at TIDES Oligonucleotide & Peptide Therapeutics in San Diego, CA on May 20-23, 2019
Intertek will be attending the DIA Global Annual Meeting in San Diego on June 23-27