Biomarkers hold the key to more personalized medicine

A number of therapeutics have been found to be ineffective in as many as 75% of patients – a significant driver in the ongoing development of precision medicine. The use of biomarkers in the drug development process is becoming increasingly popular, with success rates as much as tripling when biomarkers are employed.

In line with the increasing prevalence of personalized and precision medicine, Cerba Research has ensured optimal value by expanding and diversifying its portfolio beyond routine efficacy and safety parameters. The company is dedicated to offering a comprehensive repertoire of next-generation assays.

Cerba Research is able to deliver targeted approaches, broad immune profiling and multifactorial biomarker approaches able to identify either single or multiple biomarkers. These approaches can be customized and adapted based on clinical trial stage and biomarker purpose; for example:

  • Selection of guide doses
  • Characterization of modes of action
  • Patient stratification
  • Drug response predictions
  • Supporting the prognosis of patients
  • Disease monitoring

There is no ‘one size fits all’ approach to biomarker development, so Cerba Research is dedicated to working in partnership with its customers to develop the right solution to meet their needs. These solutions may include:

  • Transferring in-house developed assays
  • Assessing the feasibility of methods
  • Developing and validating customized assays
  • Detailed sample analysis

The company’s comprehensive range of available solutions includes:

  • Specialist testing
  • Extensive scientific expertise
  • Tailored and customized assays
  • Quality control

Circulating biomarkers

Human plasma

.
4β-Hydroxcholesterol Factor V Activity IL-10
α-GST Factor VII Activity IL-12p70
Aβ-40 Factor VIII Activity IL-12/23p40
Active B-12 Factor IX Activity IL-13
Anti-lia Factor Xa IL-15
Anti-Xa Factor X Activity IL-16
Adiponectin Factor XI Activity IL-17A
Aldosterone Factor XII Activity IP-10
Auristatin F and Auristatin F HPA Factor XIII Activity Lepin
bFGF Factor VIIIc MCP-1
Brain Derived Neurotropic Factor (Free) Factor IX inhibiting antibodies MCP-4
C3a (Complement 3a) Factor VIII inhibiting antibodies MDC
C4 (Complement 4) FGF23 MIP-1β
C5a (Complement 5a) Fibrinogen antigen NGAL
Cholesterol FLT-1 PAI-1 Ag
Cholic Acid Fructosamine PIGF
Clozapine FSH (follicle stimulating hormone) Protein C Activity
Cortisol GM-CSF Protein C Antigen
CRP GLP-1 Protein S Antigen free
Cystatin C Glucagon Protein S Total and free
DPPIV ICAM-1 Protein S Activity
Eotaxin IFNγ Osteocalcin
Eotaxin-3 IGF-2 VWF
Ergosterol IL-1α TARC
E-selectin IL-1β Tie-2
Estrone/Equiline IL-2 TNFα
Estrone sulfate/Equiline sulfate IL-4 TNFβ
Ethyl Estradiol/Norgestimate/17-Desacetyl Norgestmate IL-5 VCAM-1
Exendin 9-39 IL-6 VEGF-A
Factor II Activity IL-8 VEGF-D

 

Human urine

.
N2- (1-Carboxyethyl)-2'Deoxy-Guanosine (CEDG)
Cortisol/6β-hydroxycortisol
Creatine
CTx-II
Glucose
IL-18
KIM-1
NGAL
NTx

 

Human serum

.
Active B-12 Human IgG2 Leptin
Adiponectin Human IgG3 MCP-1
Amyloid A Human IgG4 MCP-4
Apolipoprotein A2 Human 90K/MAC-2BP MDC
Apolipoprotein C3 HMGB-1 MIP-1α
Apolipoprotein E ICAM-1 MIP-1β
APRIL IFN-α MMP-1
ATX IFN-γ MMP-2
BCMA IGF-1 MMP-3
CCL18 IFG-2 MMP-7
Chitinase 3-like 1 IGFPB-3 MMP-9
Chromogranin A IL-1β MMP-12
CK18 M30 IL-1RA MPO
CK18 M65 IL-2 Osteocalcin
Cortisol IL-4 PARC
C-peptide IL-5 S100A12
CRP IL-6 SP-A
CXCL13 IL-6 sR SP-B
E-selectin IL-7 SP-C
Estradiol (E2) IL-8 SP-D
Ethisterone IL-10 sRF
Eotaxin IL-12 TARC
Eotaxin-3 IL-12p70 Tie-2
FGF-19 IL-12/23p40 TiMP-2
FGF-21 IL-13 TK-1
Free fatty acids IL-15 TNFα
G-CSF IL-16 TNFβ
GDF-15 IL-17A VCAM-1
GM-CSF IL-27 VEGF-A
Human IgG Total Inhibin-B VEGF-C
Human β-Defensin 2 (HBD2) IP-10 VEGF-D
Human IgG1 KL-6  

 

Human cell/tissue

.
Cyp1A2
Cyp2B6
Cyp3A4

 

Whole blood

.
Factor II G20210A
Factor V Leiden
HLA genotyping

 

Human CSF

.
Aβ-40
Aβ42
hTau Ag
Phospho-tau

 

BAL fluid

.
ATX

 

Flow cytometry

Biomarkers

.    
‘X’CAR-T Any CAR-T target 'X' Drug target
Bcl2 Apoptosis regulator Apoptosis regulator
BCMA B cells, plasma cells Checkpoint, immune cell regulation
CCR7 Memory and naive T cells Immunophenotyping: T cell activation
CD4 T helper, expressed by monocytes and macrophages Immunophenotyping: T cell activation
CD5 T cells, B cells Immunophenotyping: T cell suppression
CD8 T cells, NK cells Immunophenotyping: cytotoxic T cell = activated T cell
CD11b Monocytes, MDSCs, neutrophils and macrophages,
T cells, B cells, dendritic cells
Immunophenotyping: T cell activation
CD14 Monocytes, macrophages, monocytic MDSCs, granulocytes Immune cell activation
CD15 Granulocytes, macrophages and monocytes Immune cell activation
CD16 T cells, dendritic cells, NK cells, macrophages
and monocytes, granulocytes
Immune cell activation
CD19 B cells, dendritic cells, stem cells Immune cell regulation
CD25 T cells, B cells, NK cells, macrophages and monocytes Immune cell activation
CD27 T cells, B cells, NK cells Immune cell activation
CD28 T cells T cell proliferation
CD31 T cells, B cells, NK cells, macrophages and
monocytes, granulocytes, platelets
Immune cell activation
CD33 Monocytes, MDSCs, neutrophils, macrophages Cell adhesion and signal transduction
CD38 T cells, B cells, dendritic cells, NK cells,
stem cells, macrophages and monocytes
Cell adhesion and signal transduction
CD39 T cells, B cells, NK cells, macrophages and monocytes Immune cell regulation
CD45 Activated and memory T cells, some B cells subsets,
activated monocytes and macrophages, granulocytes,
NK cells, dendritic cells
Immune cell regulation
CD47 T cells, B cells, NK cells, macrophages and
monocytes, granulocytes, platelets
Cell adhesion and signal transduction
CD52 T cells, B cells, NK cells, macrophages and monocytes Immunophenotyping: cytotoxicity
CD56 T cells, NK cells Cell adhesion
CD69 T cells, B cells, NK cells, macrophages and
monocytes, granulocytes, platelets
Immune cell proliferation and signal transduction
CD86 T cells, B cells, dendritic cells,
macrophages and monocytes
T cell activation
CD117 Stem cells/precursor Immunophenotyping: cell adhesion immune cells
CD123 Dendritic cells, stem cells, granulocytes Immune cell differentiation
CD127 T cells, stem cells, macrophages and monocytes Immune cell activation
CD137 Activated T cells, NK cells Checkpoint: immune cell regulation
CD138 B cells, stem cells Immune cell activation, cell proliferation
CD314 T cells, B cells, NK cells, macrophages
and monocytes, granulocytes
Immune cell regulation
CLL1 Car-T target Drug target
CXCR3 T cells T cell activation
CXCR4 Leukocytes, tumor cells Cell migration
HLA Antigen presenting cells Immune cell activation
Kappa Surface marker Diagnosis and identification of hematopoietic malignancies
Ki67 Tumor cells Tumor cell proliferation and growth
LAG3 Activated T cells Checkpoint, immune cell regulation
Lambda Surface marker Diagnosis and identification of hematopoietic malignancies
OX40 Activated T cells, NK cells, neutrophils Immune cell activation and differentiation
PD-1 Activated T cells, B cells Checkpoint: immune cell regulation
PD-L1 Tumor cells and immune cells including T cells,
B cells and antigen presenting cells
Checkpoint: immune cell regulation
RQR8 B cells Safety switch
TIM3 T cells Checkpoint: immune cell regulation

 

Flow cytometry panels and research

Available flow cytometry panels include:

Basic immune phenotyping panels

  • TBNK (CD4/CD8 T cells, B cells, NK cells)
  • T cell subsets (CD4/CD8 T cells)

T cell phenotyping panels

  • T cell backbone (CD45/CD3/CD4/CD8)
  • T cell activation (CD25/CD69/CD38)
  • Regulatory T cells (CD25/CD127)
  • T cell exhaustion(PD1/TIM3/LAG3)
  • T cell proliferation and survival (Ki-67/Bcl-2)
  • Naive and memory T cells (CD45RO/CD45RA/CD62L/CCR7/CD95)

B and NK cell panels

  • B cell activation (CD45/viability/CD19/CD20/CD59/CD10/CD5)
  • NK cell subsets (CD45/viability/CD3/CD16/CD56)
  • NK cell activation (CD45/viability/CD3/CD16/CD56/CD158a;b/CD314/CD335)

Other immune cell panels

  • Monocyte and neutrophil (CD45, CD14/CD15/CD11b)
  • Extensive panel (CD16/CD64/CD300e)
  • Monocytic MDSC (CD45/lineage/HLA-DR/CD11b/CD33/CD14/CD15)
  • pDC and basophil (CD45/HLA-DR/CD123/BDCA2)

Multiple Myeloma panels are also available.

Histopathology

Special stains

.
Alcian Blue
Alcian Blue/Periodic Acid-Schiff (PAS)
Alizarin Red
Azan Mallory
Bodian
Calleja
Giemsa
Gomori’s Elastin Trichrome
Gram
Hematoxylin Eosin (HE)
HE/Alcian Blue
Hematoxylin Eosin Saffron (HES)
Kluver-Barrera (Luxol Fast Blue)
Masson’s Trichrome
Methylen Blue
Movat Pentachrome
Oil Red O/Hematoxylin
Orcein
PAS
Sirius Red
Von Kossa

 

Cerba Research offers an array of cutting-edge expertise, with central review, analysis and reporting services routinely delivered by Ph.D. scientists. Thanks to its international approach and global footprint, the company can also accommodate whole blood and bone marrow aspirates.

Harmonized flow cytometry services are available in Europe, Australia, the USA and Asia (including China). Tailored solutions are available throughout these territories, including customized, fit-for-purpose flow cytometry assays.

Customized validation and analysis services

Validated panels are available to accommodate a multitude of diseases, and Cerba Research has proven excellence in enhancing assay quality of assays.

Assay results can be provided in terms of relative %, absolute cell count, as well as fluorescence quantification.

Immuno-oncology and immuno-phenotyping tools are available to analyze:

  • Regulatory T-cells (activation, proliferation, memory)
  • B cell panel
  • TBNK
  • NK cell panel

Other available tools for biomarker development include:

  • Pharmacodynamics (PD) analysis
  • Receptor occupancy (RO) and pharmacodynamics (PD)
  • Pharmacokinetic (PK) analysis
  • Expression of therapy, activation, and expansion (CAR-T, CAR-NK)

Diagnosis and Prognosis are well served by Cerba Research’s receptor occupancy (RO) and pharmacodynamics (PD) tools, while follow-up on the evolution of therapy, expression of therapy, activation and expansion can benefit from the use of CAR-T and CAR-NK analysis.

Immunohistochemistry antibodies

.    
4-1BB DDR1 MCL1
4HNE Dystrophine MelanA
5T4 E-Cadherin Muc5AC
α-SMA Elastin Na/K ATPase
β-amyloid Elastin/Vimentin Nectin-1
β-galactosidase Endocan OX-40
ARGINASE 1 ER (Estrogen Receptor) p16
BCL2 Erb BD p21
BCLXL F4/80 p40
BCM Fibrinogen p53
CA 19-9 Fibroblast p63
Caspase 3 Fibronectin PanKeratin
CC-10 Filaggrin PCNA
CD3 Fox J1 PD-1
CD4 Foxp3 PD-L1
CD8 GATA-3 pEGFR
CD11b GFAP pH2AX
CD14 GFP Plakoglobin
CD15 Glucagon p-Met
CD16 Glucagon/Insuline pS404
CD20 H.Pylori PSMA
CD30 H2A1 pStat1
CD31 HER2 pStat5
CD39 HLA pTau
CD45 HLA-DR RIPK3
CD47 HLA-E SCN5A
CD56 HLA-G SIRPa
CD68 hTERT SLC1A5
CD73 HTRA2 Spectrin
CD94 IBA1/Map2 Synaptophysin
CD138 IDO TAU
CD144-VE Cadherin IFN gamma T-Bet
CD155 IL-1α TEAD1
CD163 IL-1β TIGIT
CD226 IL-22 TIM-3
CEA iNOS TNF-α
CK5/CK6 Insulin TNFRSF14/HVEM
C-Maf Integrin 1 Tryptase
C-Met Kappa TTF-1
Collagen I Ki67 Tyrosine hydroxylase
Collagen I/Collagen III LAG-3 Vaccinia virus
Collagen III Lambda VCAM1
Collagen IV Laminin VEGRF2
Connexin 43 LC3B Vimentin
CTGF LDH VSIG4
CTLA4 Lox-1 Wheat Germ Agglutinin
Cyr61 Luciferase YAP
Cystatin MAP2  

 

Multiplex panels

.
CD3/CD8/CD226/CD155/TIGIT
Checkpoint Inhibitors (CKI) CD3/CD8/PD-1/PD-L1/IDO
Checkpoint Inhibitors (CKI) Tim3, SIRPa, E-Cadherin,
TIGIT, CD155, CTLA-4, Lag3, CD47, 4-1BB, CD226
Liver Tumor Temperature CD3/CD8/Arginase 1
Lung Tumor Temperature CD3/CD8/TTF-1
M1/M2 CD68/CD163/c-MAF/pSTAT1
MDSC CD11b/CD15/CD14/HLA-DR/LOX1
SIRPa/CD3/CD11b/CD47
Th Polarization (T-Bet/CD4/CD3/GATA3)
Treg Human CD3/CD8/CD4/CD25/FoxP3
Treg Mice CD3/CD8/CD4/CD25/FoxP3/Vimentin

 

Immunohistochemistry (IHC) at cerba research

Multiplex IHC offers the ability to measure up to 8 biomarkers simultaneously, allowing an improved understanding of spatial cellular context.

Tools are available to facilitate comprehensive immune profiling, investigation of tumor microenvironments and understanding the spatial context and co-expression of target biomarkers.

Automated slide digitization is possible for both chromogenic and fluorescent purposes, alongside enhanced software image analysis.

Multispectral scanning and imaging solutions are ideal in acquiring detailed morphological and protein expression information from cryosections, FFPE tissue or TMAs.

Technology and instrumentation for IHC

Cerba Research leverages some of the most cutting-edge technology and equipment for its biomarker research. These include:

  • Leica Bond RX
  • Leica Bond III
  • Ventana Discovery XT Ultra
  • Ventana Benchmark XT Ultra
  • Dako Autostainer Link 48
  • PerkinElmer/Akoya Vectra®

Polaris™ Hamamatsu Nanozoomer

Histoselect: antibody selection

Over 150 validated markers are available for on-demand combination and validation via strict quality controls. These can be employed in the generation of new FFPE IHC-specific antibodies.

About Cerba Research

For over 35 years, Cerba Research has been setting the industry standard for exemplary clinical trial conduct. Today, across five continents, with a focus on precision medicine, we are changing the paradigm of the central lab’s role in complex clinical research.

From protocol inception through development and to market, our passionate experts deliver the highest quality specialized and personalized laboratory and diagnostic solutions. Partner with us for the most efficient strategy to actualize your biotech and pharmaceutical products sooner and improve the lives of patients worldwide.


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Last updated: Apr 13, 2022 at 11:36 AM

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