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Bioanalysis, Biomarker, and Flow Cytometry Assay List

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Bioanalysis, Biomarker, and Flow Cytometry Assay List LABORATORY RESOURCES Bioanalysis, Biomarker, and Flow Cytometry Assay List PRA Laboratories | Solutions for Drug Development Behind every sample waiting to be analyzed, there is a patient waiting to be cured. GLP–Compliant Bioanalytical • Global Supply Logistics • Biomarker Strategic Consultation Laboratories Utilizing the following technologies and facilities: PRA maintains two modern bioanalytical laboratories in Lenexa, Kansas, USA and Assen, Netherlands. Their strategic • Sciex LC/MS/MS, Agilent, and Waters UPLC systems locations near our early phase Clinical Research Units (CRUs) • ELISA, MSD ECLIA, EMD Singulex Erenna, SMCxPro, allow time-critical and limited stability samples to be analyzed ProteinSimple ELLA, qPCR quickly. The laboratories both conduct bioanalysis of small • FACSCanto 8 Color, Fortessa 18 Color Flow Cytometers, molecules, biologics, and biomarkers for pre-clinical and and Glomax Luminescence plate reader Phase I-IV human clinical studies. They are fully harmonized • Hamilton and Tomtec Robotic Automation operations and adhere to the same stringent global regulatory • Radioisotope analysis laboratory, with a permanent license guidelines, including GLP compliance. for the analysis of radiolabeled compounds (14C, 3H) These facilities provide the ideal environment for complex • Biohazard laboratory with a Biosafety Level II license bioanalytical services, including standalone projects, those (microbiological laboratory Class II [ML-II]), qualified to combined with an early phase trial in one of PRA’s CRUs, and handle potentially infected samples those conducted in conjunction with PRA’s Product Registration • Co-located Phase I Clinics at both laboratories Services division. Both laboratories are equipped with the latest technologies and infrastructure, as required by pharmaceutical and biotechnology companies. Full-Service Clinical Laboratory Our Bioanalytical Laboratory services include: PRA also offers clinical chemistry services in a fully equipped, • Pharmacokinetic bioanalysis of small molecules and biologics dedicated laboratory. Our clinical laboratory has supported • Immunogenicity analysis and cell-based neutralizing antibody more than 3,000 clinical studies over 30 years, and can measurements (Nab) typically report data within 8 hours after sample receipt. For • Biomarker Analysis immediate safety analysis, turnaround times of 1 hour are • Flow Cytometry Analysis feasible. All analyzers are bi-directionally linked with an intelligent • Biochemistry (stimulation assays, enzymatic activity) laboratory information system, enabling fully automated, • GMP Quality Control barcode-driven analysis and reporting of results. • Radioisotope Analysis Our Clinical Laboratory services include: • Hematology, including automated differentiation • Coagulation parameters • Immunology, using both fully automated analyzers and semi-automated ELISA equipment • Urinalysis, fully automated for screening and microscopy analysis • Capabilities of LPS Challenge stimulation, PBMC-isolation techniques, and Platelet Aggregation analysis Note: for ease of business, use the search function within pdf (click “ctr+f” and type in the compound name) Bioanalytical Assays 11-Dehydro Thromboxane B2 Ambasilide 11-Deoxycortisol Amitriptyline [R]- and [S]-Ketamine 13C Radioactivity Amlodipine [R]- and [S]-Ketamine and Norketamine 14C Radioactivity Amoxicillin [R]- and [S]-Mephenytoin 17-α-Hydroxyprogesterone Amyloid β (ABeta) 42 [R]- and [S]-Methadone 17-α-Hydroxyprogesterone Caproate Angiopeptin 1 (ANG1) [R]- and [S]-Omeprazole 25-Hydroxy vitamin D Angiopeptin 2 (ANG2) [R]-Warfarin α-1-antitrypsin/ Neutrophil Elastase Anti-alkaline phosphatase antibodies 2’5’ Oligoadenylate synthetase (OAS) complex Anti-amyloid β 1-28 Abs 3-O-Methyldopa α-Glucosidase Anti-Bevacizumab 3,4-Dihydroxyphenylacetic acid α-Glutathione-S-transferase (GST) Anti-CD3 antibodies titer assay (DOPAC) and homovanillic acid (HVA) α-Synuclein bound and free Anti-cytotoxic T-lymphocyte-associated 3,4-Dihydroxyphenylglycol (DHPG) α-thrombin protein 4 (CTLA-4) 311C90 (Zolmitriptan) A proliferation-inducing ligand (APRIL), Anti-HBsAG 3H low level also known as TNFSF13 Anti-IFNα 3H Radioactivity Abacavir Anti-il20 3H-Isotretinoin Abiraterone and Abiraterone acetate Anti-IL21 4-Hydroxymephenytoin Acenocoumarol Anti-Müllerian hormone (AMH) 4 -Hydroxycholesterol β Acitretin Anti-Natalizumab antibodies 4-methyl benzoic acid (MBzA) Active Renin Anti-PEG antibodies 4 stereoisomers of Adalimumab Anti-Pembrolizumab dihydrodeutetrabenazine Adiponectin Anti-relaxin2 5-α-Dihydrotestosterone (DHT) Adrenaline Anti-Tissue Factor Pathway 5-Azacytidine Adrenocorticotropic hormone (ACTH) Inhibitor (TFPI) 5-Fluorouracil Aldosterone Anti-Trastuzumab Neutralizing Antibodies 5-Hydroxypiroxicam Aldosterone and 11-deoxy corticosterone Antipyrine 6 -Hydroxycortisol ß Alitretinoin Apolipoprotein B100 6-OH-Norketamine Alkaline phosphatase Apolipoprotein B48 7-Acetamido-clonazepam Alprazolam Apomorphine 7-α-(thiomethyl) Spironolactone Aquaporin 2 (AQP2) Complement C4 (C4) Clomipramine Aranesp Complement C4 Clonazepam Arimoclomol 7α-hydroxy-4-cholesten-3-one (C4) Clonidine Aripiprazole + Dehydroaripiprazole Complement C5 (C5) Clopidogrel active metabolite Arteether Complement C5 alpha des arg Clopidogrel and clopidogrel (C5a des arg) Artemether and dihydroartemisinin carboxylic acid Cabazitaxel Artesunate (ARTS) and Cloprednol Dihydroartemisinin (DHA) Cabozantinib Clotrimazole Ascorbic Acid Caffeine Copeptin (CPP) Asymmetric Dimethylarginine Caffeine metabolite AAMU Corticosterone (ADMA)/arginine Caffeine and Paraxanthine Cortisol Asenapine + desmethyl asenapine Candesartan Cortisol and 6-βhydroxyl cortisol Atazanavir Cannabidiol (CBD) Creatinine Atorvastatin (also known metabolites) Cannabidiol, 7-OH-CBD, 7-COOH-CBD Cromoglycate Azapropazone Cannabidivarin (CBDV) Cromolyn Azatadine Cannabidivarin deriviatives: Cromolyn Disodium Salt 6-OH-CBDV, 7-OH-CBDV and ß2-Microglobuline Culture of HELA cells 7-COOH-CBDV B-cell activating factor (BAFF) Cyanocobalamin Canrenone Bendamustine Cyclic guanosine monophosphate Capecitabin Bendamustine, M3 and M4 Metabolite (cGMP) Captopril (total) Benzylpenicillin Cyclosporine Carbamazepine Bevacizumab Cyclosporine A Carbidopa Bone-specific alkaline phosphatase (BAP) Cyclosporine and tacrolimus Cedazuridine and epimer Bortezomib CyP1b1 gene expression using qPCR Cefepime Brain-Derived Neurotrophic Factor (BDNF) CYP2C9 Ceruloplasmin Brivaracetam and metabolites Cyproterone acetate Cetrorelix Brompheniramine Cytarabine Chlorpheniramine Budesonide Cytokines (Multiplex Assays) Chlorthalidone Bumetanide Dacarbazine and Cholecystokinin (CCK) Buprenorphine and Norbuprenorphine 5-aminoimidazole-4-carboxamide Chromium-51 Bupropion and OH-bupropion Dacarbazine and AIC Cimetidine Buspirone Darbepoetin alfa (Aranesp) Cinnarizine C-terminal telopeptide type 1 (CTX-1) Dapagliflozin Circulating Tissue Factor C-terminal telopeptide type 2 (CTX-2) Dapiverine and miconazole Cisapride C-Peptide Dapivirine Clarithromycin C-terminal telopeptide (CTX) Daunorubicine (also known Clofazimine metabolites) Complement C3 (C3) Clofibric acid Decitabine Complement C3 alpha des arg (C3a des arg) Desacyl-ghrelin Efavirenz Flurbiprofen and OH-Flurbiprofen Detomidine Elastase-1 Fluvastatin Detomidine, 3-carboxy detomidine Emtricitabine Formoterol Dehydroepiandrosterone (DHEA) Enalapril Free Desmosine Dehydroepiandrosterone sulfate Enalaprilate Free IL-21 (DHEA-S) Endothelin-1 Free PTH (1-34) and Free PTH (1-33) Desogestrel Epirubicin Follicle-stimulating hormone (FSH) Deulevodopa Epirubicinol Granulocyte colony-stimulating factor Dexamethasone Erlotinib (G-CSF) Dexmedetomidine Erythromycin + N-desmethyl Guanidinoacetic acid (GAA) Dextromethorphan and dextrorphan erythromycin Gabapentin Dextromethorphan, Dextrorphan Erythropoietin (EPO) Galantamine Dextromoramide Esomeprazole Ganciclovir Dihydroxyphenylglycol (DHPG) Estetrol (E4) Growth arrest-specific 6 (GAS6) Diazepam Estradiol Gemfibrozil Diclofenac Ethambutol Gentamicin Digoxin Ethanol Glial growth factor (GGF2) Dihydroartemisinic (DHA) Ethinylestradiol Glucose-Dependent Insulinotropic Dehydronorketamine Ethionamide Polypeptide (GIP) Diltiazem Etoposide Glibenclamide Dilute Prothrombin time Everninomicin Glimepiride and 5-OH-glimepiride Dipeptidyl Peptidase IV activity (DPP-4) Exemestane Glucagon DNA Isolation Exenatide Glucagon-like peptide-1 (GLP1) total and active Docetaxel Exendin-4 Glucagon-like peptide-2 (GLP-2) Dofetilide Fatty Acid-Binding Protein 4 (FABP4) Glucaric acid Dolastatin 10 Factor anti-lla Glucose Domperidone Factor anti-Xa Glutamine synthetase Donepezil, 5-O- and Factor P Glutathione S-transferase Pi (GST-Pi) 6-O-Desmethyl Donepezil Factor VIIa Glyburide Dopamine, 3MT, deudopamine, Felbamate Deu-3MT Granulocyte-macrophage Fentanyl Doxapram and Keto-doxapram colony-stimulating factor (GM-CSF) Ferritine Doxepin Haloperidol Fexafenodine Doxorubicin Heart-type Fatty Acid Binding Protein Fibroblast growth factor 21 (FGF-21) (H-FABP) Doxorubicinol Flubendazole Helicobacter pylori Drospirenone Flubendazole metabolites Heparan Disaccharides E-Selectin Fluconazole Herceptin Eosinophil derived neurotoxin (EDN) Flupirtine, D13223 and 4-fluorohippuric High Density Lipoprotein (HDL) L-phenylalanine and trans-cinnamic acid Metoprolol and α-hydroxymetoprolol Human chorionic gonadotropin (hCG) Lamotrigine Metronidazole Human growth hormone (hGH) Lamivudine Miconazole Human vegF-A Lanosterol, Sitosterol Midazolam and 1OH-Midazolam Hydoxypropyl-ß-cyclodextrin
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