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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 [R]- and [S]- 13C Radioactivity [R]- and [S]-Ketamine and 14C Radioactivity Amoxicillin [R]- and [S]-Mephenytoin 17-α-Hydroxyprogesterone Amyloid β (ABeta) 42 [R]- and [S]- 17-α-Hydroxyprogesterone Caproate Angiopeptin 1 (ANG1) [R]- and [S]- 25-Hydroxy 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- (DHT) Adrenaline Anti-Tissue Factor Pathway 5-Azacytidine Adrenocorticotropic hormone (ACTH) Inhibitor (TFPI) 5-Fluorouracil Anti-Trastuzumab Neutralizing Antibodies 5-Hydroxypiroxicam Aldosterone and 11-deoxy Antipyrine 6 -Hydroxycortisol ß Alitretinoin Apolipoprotein B100 6-OH-Norketamine Alkaline phosphatase Apolipoprotein B48 7-Acetamido- Apomorphine 7-α-(thiomethyl) 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 Ascorbic Acid Copeptin (CPP) Asymmetric Dimethylarginine Caffeine metabolite AAMU Corticosterone (ADMA)/arginine Caffeine and Paraxanthine Asenapine + desmethyl asenapine Candesartan Cortisol and 6-βhydroxyl cortisol Atazanavir (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) Cyclosporine Bevacizumab Cyclosporine A Carbidopa Bone-specific alkaline phosphatase (BAP) Cyclosporine and Cedazuridine and epimer Bortezomib CyP1b1 gene expression using qPCR Cefepime Brain-Derived Neurotrophic Factor (BDNF) CYP2C9 Ceruloplasmin Brivaracetam and metabolites Cetrorelix Brompheniramine Cytarabine Chlorpheniramine Budesonide Cytokines (Multiplex Assays) Chlorthalidone Bumetanide Dacarbazine and Cholecystokinin (CCK) and 5-aminoimidazole-4-carboxamide Chromium-51 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 Flurbiprofen and OH-Flurbiprofen Detomidine Elastase-1 Fluvastatin Detomidine, 3-carboxy detomidine Emtricitabine Formoterol (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 Erlotinib (G-CSF) + N-desmethyl Guanidinoacetic acid (GAA) and erythromycin Gabapentin Dextromethorphan, Dextrorphan Erythropoietin (EPO) Galantamine Esomeprazole Ganciclovir Dihydroxyphenylglycol (DHPG) (E4) Growth arrest-specific 6 (GAS6) Gemfibrozil Diclofenac Ethambutol Gentamicin Digoxin Ethanol Glial growth factor (GGF2) Dihydroartemisinic (DHA) 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 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 synthetase Donepezil, 5-O- and Factor P Glutathione S-transferase Pi (GST-Pi) 6-O-Desmethyl Donepezil Factor VIIa Glyburide Dopamine, 3MT, deudopamine, Deu-3MT Granulocyte-macrophage Doxapram and Keto-doxapram colony-stimulating factor (GM-CSF) Ferritine 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) , 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 and 1OH-Midazolam Hydoxypropyl-ß-cyclodextrin Leptin (Human) Hydrochlorothiazide Leukotriene B4 and E4 Mitoxantrone and Acetaminophen (Very) Low Density Lipoprotein (LDL/VLDL) Moclobemide Hydrocodone and Levetiracetam Mometasone Hydroxypropyl-β-cyclodextrine Levonorgestrel Monocyte Chemotactic Protein-1 Ibuprofen Levodopa (MCP-1)/IP-10 Idazoxan Luteinizing hormone (LH) Monohydroxycarbamazepine Idarubicin and Idarubicinol Lidocaine Monomethyl auristatin E (MMAE) Idebenone Lopinavir, darunavir and Monomethoxypoly ( glycol) mPEG IgG IgG anti-p17 Losartan Motilin Inactivated complement 3b (iC3b) Moxifloxacin Loxoprofen + 2 metabolites Indocyanine green LPS Challenge test Naproxen Infliximab LPS/PGE2 stimulation Natalizumab Inhibin B Lumefantrine Nefopam Insulin Mannose Associated Serine Protease 2 Nelfinavir and Nelfinavir-M8 Insuline like growth factor (IGF-1) (MASP-2) Neopterin Iohexol Macrophage colony-stimulating factor Neutrophil Elastase 1 (CSF-1) Irinotecan, SN-38 and SN-38-glucuronide Neurofilament Light (NF-L) Matrix metalloproteinase-1 Isepamicin Neutralizing anti-FA relaxin antibodies (MMP-1; total) Isoniazid and pyrazinamide Neutrophil gelatinase-associated Monoamine Oxidase B (MAO-B) activity lipocalin (NGAL) Isotretinoin Megestrol acetate Insulin Nerve Growth Factor (NGF) Intercellular adhesion molecule (ICAM) Melperone adenine dinucleotide Intestinal-type Fatty Acid Binding Memantine (NAD+) Protein (I-FABP) Metformin Metabolites Itraconazole and 2-OH-Itraconazole Methadone Jo-1, polyclonal antibody Methotrexate + 7-OH-methotrexaet Niraparib Kanamycine Methylphenidate Ketamine Methylthioninium (free and conjugated) Noradrenaline Methylthioninium and desmethyl Norethindrone Kidney Injury Molecule-1 (KIM-1) methylthioninium Norgestrel L-Dopa Norketamine Pilocarpine Activitor for Nuclear Factor B Pimozide (RANK) N-telopeptide of type I collagen (NTX-I) Pindolol Recombinant follicle stimulating hormone (rFSH) N-terminal pro b-type natriuretic peptide Pioglitazone Recombinant human α-galactosidase A (NT-proBNP) Pioglitazone and rosiglitazone (rh-alpha-Gal A) Pioglitazone metabolites MIII and MIV Recombinant human Growth Hormone Odalasvir Piroxicam (rhGH) Plasminogen activator inhibitor-1 (PAI-1) Recombinant human Lactoferrin (rhLF) Olanzapine Polyethylene glycol (PEG) Red Blood Cell (RBC) lysis Omeprazole and 5-hydroxyomeprazole Ponesimod Regulated on Activation, Normal T Cell Ondansetron Pravastatin Expressed and Secreted (RANTES) Oseltamivir, Oseltamivir Carboxylate Pre-Albumin Regorafenib, M2 + M5 Osteocalcin Relaxin 2 Osteopontin (OPN) sulphate Renin activity Pretomanid (PA-824) Renin concentration , noroxycodone, Repirinast metabolite Bay w 8199 acetaminophen Pro-atrial natriuretic peptide (pro-ANP) Retinol-binding protein 4 (RBP4) Oxytocin ProANP (1-98) Rheumatoid factor (RF) p-Aminohippuric acid (PAH) Probenecid Ribavirine p-Hydroxy- (total) Procollagen C-terminal peptides (PICP) Rifabutin and 25-O-Desacetylrifabutin P-Selectin Procollagen I N-terminal peptides (PINP) and 25-desacetyl rifampicin , allopregnenolone, Rifapentine and 25-desacetyl-rifapentine Palbociclib pregnanolone Rimantadine Paliperidone and paliperidone palmitate pro-hepcidine Risperidone and 9-Hydroxyrisperidone Paliperidone enantiomers Prolactin Risperidone and Paliperidone Palonosetron Propafenone Ristocetin cofactor (RICO) Pancreatic polypeptide (PP) Proprotein convertase subtilisin/kexin Ritonavir Paracetamol and metabolites type 9 (PCSK9) Rivastigmine Parathyroid hormone (PTH) / PTH Total Prostaglandine E2 Rosiglitazone and Paroxetine Prothrombin Fragment F1 + F2 desmethylrosilitazone Pegylated Granulocyte Colony Pseudoephedrine Rosuvastatin and 2 metabolites Stimulating Factor (PEG-G-CSF) Pyrazinamide Rotigotine Pembrolizumab Rabeprazole S-citalopram Pemetrexed Radiprodil and metabolites S-ketamine Peptide tyrosine tyrosine (PYY) Raltegravir Salbutamol Phenobarbital (total) Ramucirumab Salicylic acid and Acetyl Salicylic acid Ranitidine Saquinavir Phosphorylated tau (pTau) Rat C-peptide sCD40L Scopolamine Total sE-selectin + sP-selectin and tapentadol Total desmosine and isodesmosine Selexipag glucuronide Total Dopamine Serum Amyloid A (SAA) Tasquinimod Total IgE Serum surfactant protein D (SP-D) Temsirolimus Total IL-21 binding globulin (SHBG) Tenofovir and Adefovir Total PEG Terbutaline sICAM + sVCAM Transforming growth factor β1 (TFG-β1) sIL-6R Teriflunomide Total sitosterol and simvastatin acid Total Tau Simvastatin-derived HMG-CoA (THC) Total proanthocyanidins contents (TPAC) and metabolites reductase inhibitors Terephthalaldehyde (TPAL) Thalidomide Simvastatin+ metabolite Trabectin Theophylline (+/-) and its matabolites (+/-) Thiamine Sitagliptin Trastuzumab Thiobarbitoric acid reactive substances Soluble BCMA (sBCMA), Free/Total Trastuzumab emtansine (catabolites) (TBARs) Soluble CD25/IL-2Rα Thrombin-antithrombin complex (TAT) Soluble CD62L Tretinoin Thrombin generation Soluble Transferrin Receptor Thymus and activation-regulated Soluble tumor necrosis factor receptor chemokine (TARC) Triclabendazole, triclabendazole type 1 (sTNF-R1) sulfoxide and triclabendazole sulfone Thyroid stimulating hormone (TSH) Soluble tumor necrosis factor receptor Trimethoprim type 2 (sTNF-R2) Thyroxine (T4) Sorafenib Thyroxine binding globulin (TBG) Tromboxane B2 Sorivudine Tyramine Spironolactone Tiludronate Tysabri Timolol Ubiquinone Sulfapyridine Tirofiban Urotensin II Sulindac Tocilizumab Urotensin Related Peptide (URP) Sulphamethoxazole Tofisopam Vaccine antibody titer Sulpiride Tolbutamide, 4-hydroxytolbutamide and carboxytolbutamide Valpatasvir Sumatriptan Tolterodine and Vascular cell adhesion molecule 1 5-hydroxymethyl tolterodine (VCAM-1 CD106) Tadalafil Tonabersat and SB-277726 Vascular endothelial growth factor (VEGF) Tamiflu Topotecan VegF soluble receptor 2 von Willebrand factor (VwF) PRA laboratories have experience with all assays listed above. Some of these assays, however, may be Protoporphyrin validated at a single laboratory location or otherwise not be fully validated up to current standards. In those cases, assays might need some additional validation efforts. PRA is open to discussing absorbing the costs related to the additional experiments and ownership for the methods. Please contact us for detailed information on the assays and their status. Flow Cytometry Lab Assays

Short description Markers

Immune Phenotyping - basic

T cells (CD4 and CD8) immunophenotyping CD45,CD3,CD4,CD8

T, B, and NK cell immunophenotyping CD45,CD3,CD19,CD16,CD56

Monocytes and granulocytes immunophenotyping CD45,CD14,CD16

B-cell Immunophenotyping using Trucount CD3,CD5,CD20,CD45

CD34+ leukocytes in human whole blood CD45,CD34

T, B, NK, neutrophils and monocytes immunophenotyping CD3,CD4,CD8,CD45 + CD3,CD45,CD19,CD16,56 + CD45,CD16,CD14 (numbers and percentage)

Leukocyte subsets in human whole blood CD3,CD4,CD8,CD45RA,CD45RO,CD45 + CD20,CD83,CD16,CD56,CD3,CD45

CD16 expression on monocytes (subset identification CD45,HLA-DR,CD16,CD14 and enumeration)

CD4+,CD25+,FOXP3+ regulatory T-cells CD4,CD25,FoxP3

Distribution of various T cell subsets CD4,CD134,CD25,CD8,CD3,CD45RO,CD56,CD16

CD25+ blasts whole blood and bone marrow CD25,CD34,viability

CD25+ blasts and target receptors, whole blood CD25,CD34,CD99,CD123,viability + CD25,CD34,CD122,CD132,viability and bone marrow

CD19 and associated receptors in whole blood CD20,CD79b,CD19,CD22,CD45,CD21 and bone marrow

CD10 positive B-cells CD45,CD3,CD19,CD20,CD10

Fetal hemoglobin (HbF) expression on Red blood cells CD345a,7-AAD,HbF

Immune Phenotyping - deep

CD4,CD8,CD19,CTLA-4,CD25,PD-1,CD69,CD45RO + CD11b,CD83,CD11c,CD14,CD16, PD-1 and CTLA-4 on B-cells, T-cells and monocyte subsets CD80,HLA-DR,CD40 PD-1 in leukocyte subsets T-, B- and NK-cells (CD4,CD8 T-cells, naïve and CD3,CD4,CD8,CD45RO,CD19,CD27,CD16,CD56,PD-1 memory B- and T-cells)

CTLA4+ Tregs in whole blood CD4,CD25,FoxP3,CD152

CD3,CD4,CD8,CD185,CD279,CD278,CD45RA,CD57,CD3, CD3,CD4,CD8,CD197, Deep T-cell phenotyping CD45RO,CD95,CD69,CD28,CD3,CD4,CD8,CCR4,CCR6,CXCR3,HLA-DR,CD154

CD19,IgD,CD27,CD38,CD24,CD95,CD86,CD21 , CD83,CD40,CD80,CD303,CD86, B-cells, dendritic cells and IFN regulated genes HLA-DR,CD1c,Lin1 , CD19,IgD,CD27,CD38,CD14,CD16,CD169,CD64 Immune Phenotyping - deep (Continued)

T, B, NK cells and CD14 monocytes in cryopreserved PBMC samples CD3,CD45,CD4,CD8,CD19,CD16+56,CD14,viability

CD3,CD4,CD8,CD185,CD279,CD278,CD45RA,CD57/ CD3,CD4,CD8,CD197,CD45RO, Extensive T-cell phenotyping CD95,CD69,CD28 / CD3,CD4,CD8,CCR4,CCR6,CXCR3,HLA-DR,CD154

CD19,IgD,CD27,CD38,CD24,CD95,CD86,CD21 / CD83,CD40,CD80,CD303,CD86, B-cells, dendritic cells and IFN regulated genes HLA-DR,CD1c,Lin1 / CD19,IgD,CD27,CD38,CD14,CD16,CD169,CD64

CD57,CD279,CD278,CD45RA,CD185(CXCR5),CD8,CD3,CD4 / CD8,CD194,CCR4, 2 panel extended T-cell phenotyping CD196 (CCR6),HLA-DR,CD154+CD3,CD4,CD183 (CXCR3)

CD3,HLA-DR,CD45RA,CCR4 (CD194),CD4,CXCR3 (CD183),CD127,CCR6 (CD196), Multiple markers for T-cells CCR7 (CD197),CD25,CD45RO,CD8,CD38

CD19,IgD,CD38,CD20,CD24,CD34,CD21,IgM,CD138,CD10,CD27,CD45 and Multiple markers for B-cells Lineage- (=CD3,CD14)

Th1, Th2, Th17 & Th22 T cell subsets CD45,CD3,CD4,CCR6,CCR4,CXCR3,CCR10,CD69

Dendritic cells Lin1-,CD80,CD1c,CD83,HLA-DR,CD40,CD303(BDCA2),CD86

B and NK cell immunophenotype CD19,CD27,CD38,CD138,CD56,CD24,CD45

T cell immunophenotype CD25,CD8,CD279 (PD-1) CXCR5,CD127,CD3,ICOS,CD4

Determination of a receptor on the cell surface of monocytes, DCs, B cells CD45,CD19,CD14 ,CD32,CD64 ,CD16 ,CD3,CD56,CD11c,CD123,HLA-DR

Regulatory T cell function – Panel 1 CD25,CD39,CD3,FOXP3,CD45,CD4,HELIOS,CTLA-4

Regulatory T cell function – Panel 2 CD25,CD3,CD278 (ICOS),OX40,FOXP3,CD4,CD279 (PD-1),CD45

Regulatory T cell function – custom CD3, CD4, CD25, CD127, FoxP3, CD45RO, CD45RA

Activation markers

CD63 activation in basophils after FCeR1 stimulation; flow CAST kit CCR3,CD63

CD63 activation in basophils after IL-3 and IgE stimulation CD63,CCR3 (not Flow CAST kit)

MHC-II on B cells and monocytes CD45,CD19,CD14,MHC-II phosphorylated proteins in PBMC CD20,CD45,CD14,CD3,pospho proteins pBTK, pPLCg, pERK

Stimulation of B-cells for phospho proteins CD20,CD3,pSyk,pBTK,pERK

Inhibitory effects of HDAC inhibitor on acetylation CD3,acetylated α tubulin,acetylated histone,monocytes

Inhibitory effects of HDAC inhibitor on total protein CD3,total α tubulin,total histone,monocytes pSTAT5 and pSTAT2 assay CD3,CD45,pSTAT2,pSTAT5 Activation markers (continued) ligand Induced CD69 expression CD69,CD19,viability

CCL3,CCL4 levels CCL3,CCL4 ligand induced CD319 expression in monocytes CD319,CD14,viability

T-cell proliferation after PHA stimulation or compound stimulation CD3,CD45,EdU,viability pSTAT5 activation in regulatory T cells CD25,CD8,CD3,FOXP3,CD45,CD4pPSTAT5

Regulatory T cell proliferation CD45,CD3,CD4,CD8,CD16,CD56,CD25,FOXP3,Ki67

S6 , Akt in human whole blood anti-S6,anti-Akt pCREB levels CD8α,CD14,pCREB

Phenotype B, T and NK cell + CD69 CD45,CD3,CD4,CD8,CD16,CD19,CD69

CD18, CD11b, CD62 and CD45 expression on granulocytes (combi with CD18,CD11b,CD62L,CD45 stimulation) pAKT in human B-lymphocytes from PBMCs pAkt(Ser),pAkt (Thr308),S6(Ser235,236),CD19

Cell-cycle determination,cell proliferation (determination of DNA CD3,CD45,EdU synthesis) pSTAT5 in human whole blood on T-cells and granulocytes pSTAT5

S6 , Akt in human whole blood anti-S6 , anti-Akt

S6 , Akt CD20,S6,pAKT actin polymerization in CD4+,CCR4+ cells CD4,CCR5,phalloidin pSTAT5 in human whole blood on T-cells after IL-2 stimulation pSTAT5 pSTAT5 in human whole blood on granulocytes after GM-CSF stimulation pSTAT5

CCR3 & CD63 after anti-IgE stimulation (fMLP) CCR3,CD63

CD18, CD11b, CD62 and CD45 expression on granulocytes (combi with CD18,CD11b,CD62L,CD45 stimulation)

Ki67, ICOS, PD-1 AND CTLA-4 CD45, CD3, CD4, CD8, PD-1, ICOS, Ki67, CTLA-4

IgE on the surface of basophils CD45, CD14, HLADR (MHC Class II), CD123, CCR3 (CD193), IgE

IL-6 and IL-10 mediated STAT3 phosphorylation in T and B cells CD45, CD3, CD4, CD20 and pSTAT3

IL-23 mediated STAT3 phosphorylation in T cells CD3, CD4, CD8, CD161 and pSTAT3 Receptor Occupancy (RO),

α4-Integrin saturation in Human Whole blood by Flow Cytometry CD45, anti-IgG4

FcGamma RO and phenotyping on granulocytes and monocytes CD45, CD14, CD3, CD19, CD56, CD11c, CD49d

Receptor occupancy on non-classical monocytes in whole blood CD45 PerCP-Cy5.5,CD14 APC,HLA-DR BB515,CD16 BV421,compound + anti-IgG4-PE.

Fc Receptor occupancy on monocytes - membrane and intracellular CD14,CD66,CD3,CD20,CD45,Fixable Viability Stain 780

C5aR occupancy

Receptor occupancy on monocyte precursor cells in human bone marrow compound + IgG4-PE,CD38,7-AAD,CD34,CD3

TLR receptor occupancy on monocytes CD14,CD45,compound + anti-IgG4

CD19 receptor occupancy + CD32b expression IgD,CD45,CD27,CD20,CD3,CD19 + IgD,CD45,CD27,CD20,CD3,CD32b

Other, e.g. Neutralizing antibody assays, Cell cycle status, Cytometric bead array, etc.

Complement pathway in serum using a bead assay C3c,C4d

Cell-cycle determination, cell proliferation (determination of DNA CD45,CD34,CD38,CDCD11b,CD14,CD61,CD71,Draq5 synthesis) in bone marrow

Neutralizing antibodies CD45 pSTAT3, multiple based on existing receptor occupancy assay format

Cytometric Bead Array (cytokine detection in serum) IL-2,IL-4,IL-6,IL-10,TNF,IFN-γ,IL-17A

The Flow Cytometry department can also perform the following services:

• Full development/transfer of flow cytometry and other cell-based assays • Assay qualification/Full validation • Bioanalysis (early through late phase clinical studies) • Flow cytometry panel design, including optimized fluorochrome selection • Data analysis using De Novo FCS Express 21 CFR Part 21 compliant software • Isolation and cryopreservation of Peripheral Blood Mononuclear Cells (PBMC) • Isolation and cryopreservation of bone marrow Mono Nuclear Cells (MNC) • Isolation of polymorphonuclear cells from whole blood • Ex vivo stimulation assays of whole blood and PBMC • Cell-based neutralizing antibody assays with flow cytometry and/or luminescence read-out • Cell culture of cell lines for the purpose of cell-based (neutralization) assays • Basic hematology analysis using Sysmex whole blood analyzer Lithium Methadone Clinical Lab: Magnesium Methaquolone Microalbumin Safety Assays Nicotine NGAL Opiates Clinical Chemistry Potassium ACTH Sodium Propoxyphene ALAT Total Bile Acids Tricyclic Antidepressivants (TCA) Albumin Total Protein Alkaline Phosphatase Triglycerides Hematology Amylase - Pancreas Urea/BUN Absolute Neutrophil Counts (ANC) Amylase - Total Uric Acid Hematocrit (HCT) ASAT VLDL Cholesterol Bicarbonate Hemoglobin (HGB) Immature Reticulocyte Fraction (IRF) Bilirubin - Direct Coagulation Mean Corpuscular Hemoglobin (MCH) Bilirubin - Total Anti-Thrombin III Mean Corpuscular Hemoglobin Bilirubin - Unconjugated (Indirect) aPTT Concentration (MCHC) Calcium D-Dimer Mean Corpuscular Volume (MCV) Chloride Factor V Leiden Mean Platelet Volume (MPV) Cholesterol Fibrinogen Myeloperoxidase Index (MPXI) Cholinesterase Free Protein C Nucleated Red Blood Cells (NRBC) Creatinine Free Protein S Platelet Distribution Width (PDW) Creatininekinase (CK) Plasminogen Platelets (PLT) Cystatin C PT Red Blood Cells (RBC) Free Fatty Acids PT (INR) Red Cell Relative Distribution Width Fructosamine TT (RDW) GGT Reticulocyte Cell Hemoglobin Content GLDH Drugs of Abuse (CHr) Globuline Acetaminophen Reticulocyte Hb (Ret-Hb) Glucose Amphetamines Reticulocytes (RETIC) HBDH White Blood Cell Differentiation HDL Cholesterol (automated) Inorganic Phosphate Buprenorphine White Blood Cell Differentiation Iron (manual diff) Iron Binding Capacity - Total (TIBC) White Blood Cells (WBC) Iron Binding Capacity - Unconjugated Ecstacy (XTC) (UIBC) Ethanol Serology Lactate Ethyl Glucuronide Anti-HAV IgM LDH Gamma Hydroxy-Butyric Acid (GHB) Anti-HAV Total LDL Cholesterol MDMA Anti-HBc IgM Lipase Methamphetamine Anti-HBc Total Anti-HBs Cytokines Anti-HCV Clinical Lab: IL-1 β Anti-Mycoplasma Pneumoniae IgG Specialty / IL-6 CMV IgG Disease Assays IL-8 CMV IgM TNF α EBV-VCA-IgG Anemia EBV IgG antibodies Nuclear Antigen Erythropoetin Hormones EBV-VCA-IgM Folate ACTH H. influenza B IgG Ferritin H. pylori IgG Haptoglobin β-HCG HBsAg Hepcidin Cortisol Herpes Simplex IgG Iron Binding Capacity Estradiol Herpes Simplex IgM Red-Cell Folate FSH HIV I/II, P24 antigen Soluble Transferrin Receptor (sTfR) FT3 IgG Antibodies HSV Type 1 and 2 Transferrin FT4 IgM Antibodies HSV Type 1 and 2 Vitamin B12 Growth Hormone (GH) Meningococcus IgG Insulin Tetanus Toxin IgG Bone Metabolism LH Tuberculosis (Quantiferon GoldTM) Clusterin (APO-J) Progesterone Varicella Zoster IgG CTX-1 Prolactin Oteocalcin T3 Urinalysis (semi-quantitative) Osteopontin T4 Bilirubin Vitamin D Testosterone Colour TSH Erythrocytes Cardiac Glucose Apolipoprotein A‑1 Inflammatory Ketones Apolipoprotein B A1‑Acid Glycoprotein (A1AG) Leucocytes BNP Alpha-1-Antitrypsin (AAT) Microscopy ( sediment) CKMB Complement C3 Nitrite High sensitive CRP Complement C4 pH hs Troponin I C-Reactive Protein (CRP) Protein Myoglobulin Erythrocyte Sediment Rate (ESR) Specific Gravity NT-ProBNP IgA Turbidity ST2 IgE Urobilinogen Troponin T IgG IgG-subclasses 1-4 IgM

Kidney markers β-NAG Aldosteron KIM-1

Proteins & Peptides Alkaline Phosphatase - Bone & Liver Fraction CK isoenzymes Protein Electrophoresis

Tumor Markers Her2neu PSA

Other HbA1c Occult blood (faeces) AUG2020 PRA Health Sciences conducts comprehensive Phase I-IV biopharmaceutical drug development. To learn more about our solutions, please visit us at prahs.com or email us at [email protected].