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Precision for Medicine

Bethesda, Maryland, US

Precision’s specialty in vitro and ex vivo assays achieve a variety of research, safety, efficacy, and biomarker objectives. Meticulous sample handling and sophisticated global logistics are fundamental for achieving high-quality, accurate study results. Our services include research and clinical trial support, backed by our repository, cell biology, sample processing, and molecular capabilities—all with industry-leading quality systems, including GxP, ISO 9001, ISO 13485, College of American Pathology (CAP), and Clinical Laboratory Improvement Amendments (CLIA).

Our services include:

Advanced custom assays. We build our custom cell-based assays using cell lines or primary cells (both normal and patient-derived). We also deliver novel ligand-binding assay approaches for greater ease of validation and scalability. Our assays are run routinely to support preclinical and clinical studies.

Global biorepositories... Show more »

Precision’s specialty in vitro and ex vivo assays achieve a variety of research, safety, efficacy, and biomarker objectives. Meticulous sample handling and sophisticated global logistics are fundamental for achieving high-quality, accurate study results. Our services include research and clinical trial support, backed by our repository, cell biology, sample processing, and molecular capabilities—all with industry-leading quality systems, including GxP, ISO 9001, ISO 13485, College of American Pathology (CAP), and Clinical Laboratory Improvement Amendments (CLIA).

Our services include:

Advanced custom assays. We build our custom cell-based assays using cell lines or primary cells (both normal and patient-derived). We also deliver novel ligand-binding assay approaches for greater ease of validation and scalability. Our assays are run routinely to support preclinical and clinical studies.

Global biorepositories and biobanking. Precision manages 25 million + biospecimens—with samples from over 100 active clinical trials on 6 continents. We house samples in LN 2 , at -80; -20; +4ºC; and ambient temperature—all conditions that are replicated in our biorepositories worldwide to ensure accurate, consistent research results.

Consistent specimen collection. With real-time sample processing occurring in over 50 countries on 6 continents, we are able to manage the sample from draw to assay, streamlining handling and ensuring sample preservation, integrity, and consistency.

Clinical immune monitoring. Our comprehensive assessment of immune status and function informs preclinical and clinical trials and post-market surveillance. Our technology platforms include flow cytometry, ELISpot, Nanostring, and multiplexed cytokine assessments that can be implemented consistently at scale.

Bioanalytical services for large molecules. Our renowned scientific leadership helped establish the basis of FDA and EMA guidance in immunogenicity. Our passions include assays for PEGylated proteins, ADCs, bispecifics, gene therapies, CAR-T’s novel techniques such as drug-specific IgE assays, and assessments of complement activation.

Precision for Medicine, part of the Precision Medicine Group, announced today that it has acquired Applied Immunology, an established expert in the creation and delivery of custom cell-based and immunoassay solutions. Applied Immunology supports innovative and targeted therapeutics developers across all areas, ranging from immuno-oncology to rare diseases to biosimilars from research to post-approval. Applied Immunology strengthens and expands Precision's specialty laboratory services in cell-based and immunoassays, and creates state-of-the-art laboratory access for Precision's west coast biotechnology clients. Applied Immunology is a specialty research laboratory with a focus on developing, validating, and implementing assay solutions. Its core area of focus includes custom cell-based assays, bioanalytical assays with a focus on biologics, and clinical immune monitoring of products in development and on the market.

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Normal Human Peripheral Blood Mononuclear Cells (PBMCs)
Starting at $125.00 per unit

Normal Human PBMC Purified, Characterized
10 Million cells/vial
Starting at $125.00 per unit

Our product inventory encompasses more than 100 unique donor lots, each characterized by testing and demographic data.

Basic demographics: age, gender, ethnicity, height, weight
Matched plasms available
HLA Class-I and... Show more »

Normal Human PBMC Purified, Characterized
10 Million cells/vial
Starting at $125.00 per unit

Our product inventory encompasses more than 100 unique donor lots, each characterized by testing and demographic data.

Basic demographics: age, gender, ethnicity, height, weight
Matched plasms available
HLA Class-I and Class-II type information
IFN-γ ELISpot responses against PHA, CEF, and CMV stimulants
MTT-based proliferation index
ADCC testing results for select lots
FACs purity analysis for purified PBMC subsets
Tested negative for HIV, HBV, and HCV

Normal Human PBMC Purified, Characterized
50 Million cells/vial
Starting at $249.00 per unit

Our product inventory encompasses more than 100 unique donor lots, each characterized by testing and demographic data.

Basic demographics: age, gender, ethnicity, height, weight
Matched plasms available
HLA Class-I and Class-II type information
IFN-γ ELISpot responses against PHA, CEF, and CMV stimulants
MTT-based proliferation index
ADCC testing results for select lots
FACs purity analysis for purified PBMC subsets
Tested negative for HIV, HBV, and HCV

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Human Monocytes
Starting at $350.00 per unit

Human CD14+ Monocytes, Negatively Selected, 5-8 million

Human CD14+ Monocytes, Negatively Selected, 5-8 million

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Biomarker Analysis
Price on request
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Clinical Biomarkers
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Immunoinformatics
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Flow cytometry and immunosequencing produce high-content data, which can be complex to mine—especially manually; our team infuses your research with efficiency and reproducibility.

Flow cytometry and immunosequencing produce high-content data, which can be complex to mine—especially manually; our team infuses your research with efficiency and reproducibility.

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Bioinformatics Data Analysis
Price on request

Biomarker Statistics

Stratify patients, identify a novel drug target, or understand an MoA. Our team of experts deploys novel algorithms and strategies to uncover hidden insights.

Biomarker Statistics

Stratify patients, identify a novel drug target, or understand an MoA. Our team of experts deploys novel algorithms and strategies to uncover hidden insights.

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Biomarker Data Management
Price on request

Rapidly harmonize, synthesize, and visualize specialty lab data from multiple vendors and diverse assays.

Rapidly harmonize, synthesize, and visualize specialty lab data from multiple vendors and diverse assays.

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Human Biofluids
Price on request

With real-time sample processing occurring in over 50 countries on 6 continents, we are able to manage the sample from draw to assay, streamlining handling and ensuring sample preservation, integrity, and consistency.

With real-time sample processing occurring in over 50 countries on 6 continents, we are able to manage the sample from draw to assay, streamlining handling and ensuring sample preservation, integrity, and consistency.

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Bioanalytical Assays
Price on request

Our renowned scientific leadership helped establish the basis of FDA and EMA guidance in immunogenicity. Our passions include assays for PEGylated proteins, ADCs, bispecifics, gene therapies, CAR-T’s novel techniques such as drug-specific IgE assays, and assessments of complement activation.

Our renowned scientific leadership helped establish the basis of FDA and EMA guidance in immunogenicity. Our passions include assays for PEGylated proteins, ADCs, bispecifics, gene therapies, CAR-T’s novel techniques such as drug-specific IgE assays, and assessments of complement activation.

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Human Biobanking
Price on request

Precision manages 25 million + biospecimens—with samples from over 100 active clinical trials on 6 continents. We house samples in LN 2 , at -80; -20; +4ºC; and ambient temperature—all conditions that are replicated in our biorepositories worldwide to ensure accurate, consistent research results.

Precision manages 25 million + biospecimens—with samples from over 100 active clinical trials on 6 continents. We house samples in LN 2 , at -80; -20; +4ºC; and ambient temperature—all conditions that are replicated in our biorepositories worldwide to ensure accurate, consistent research results.

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ELISA
Enzyme-linked immunosorbent assay
Price on request

We provide services under GLP and FDA guidelines for:

• ELISA based assays
• Cell based immunoassays

Capabilities:
- Kit-based, custom designed ELISA
- Sandwich, competitive, and bridging formats
- Optimization of protocols for commercial ELISA kits
- Analyze serum, plasma, celline supernatant's, cell lysates
-... Show more »

We provide services under GLP and FDA guidelines for:

• ELISA based assays
• Cell based immunoassays

Capabilities:
- Kit-based, custom designed ELISA
- Sandwich, competitive, and bridging formats
- Optimization of protocols for commercial ELISA kits
- Analyze serum, plasma, celline supernatant's, cell lysates
- Analyze fluorescent/chemiluminescent/chromogenic/substrates

Equipment:
-Perkin Elmer, Envision/Enspire
-Multi-channel pipets

Number of samples processed in a single experiment: 72

Typical turn-around: 5 days

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Flow Cytometry
Price on request

Flow cytometry (and immunophenotyping) for high-throughput, multi-parameter analysis of cell subsets (up to 18 colors, research, and CLIA).

Flow cytometry (and immunophenotyping) for high-throughput, multi-parameter analysis of cell subsets (up to 18 colors, research, and CLIA).

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NanoString nCounter Analysis
Price on request
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ELISpot Assays
Enzyme-Linked ImmunoSpot Assays
Price on request

ELISpot testing across multiple phases of clinical trials

ELISpot testing across multiple phases of clinical trials

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NAb Assays
Neutralizing Antibody Assays
Price on request

Neutralizing antibody (cell- or non cell-based)

Neutralizing antibody (cell- or non cell-based)

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GPCR Screening and Profiling
Price on request

Reporter gene analysis GPCRs function

Reporter gene analysis GPCRs function

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Cell Viability Assays
Price on request

Cell viability, apoptosis / necrosis

Cell viability, apoptosis / necrosis

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Assay Development
Price on request

At Precision for Medicine we understand that the route from assay development to commercialization is complex. So, our comprehensive suite of solutions is designed expressly to help your advanced in vitro, laboratory-developed, and companion diagnostics take the shortest path from test concept through clinical trial development,... Show more »

At Precision for Medicine we understand that the route from assay development to commercialization is complex. So, our comprehensive suite of solutions is designed expressly to help your advanced in vitro, laboratory-developed, and companion diagnostics take the shortest path from test concept through clinical trial development, and over regulatory hurdles to reimbursement and market uptake.

We focus on the end from the very beginning, cutting through clutter and helping you reach your goal faster. Our integrated team understands how the pieces fit together, and ensures that learnings from each stage inform the rest of the process. The result: We’ve delivered more than 250 market clearances and approvals along with numerous favorable coverage and payment decisions for hundreds of diagnostic products—including many game-changing, first-to-market innovations

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Enzyme-linked immunosorbent spot
Price on request

ELISpot testing across multiple phases of clinical trials

ELISpot testing across multiple phases of clinical trials

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T Cell Activation and Proliferation Assays
Price on request

T- and B-cell proliferation

T- and B-cell proliferation

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Immunophenotyping
Price on request

via flow cytometry (up to 18 colors, research, and CLIA)

via flow cytometry (up to 18 colors, research, and CLIA)

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In vitro Immune Function Testing
Price on request

Immune function (T, B, NK, NKT, Treg, Neutrophils)

Immune function (T, B, NK, NKT, Treg, Neutrophils)

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Human Tissue Procurement
Price on request

With real-time sample processing occurring in over 50 countries on 6 continents, we are able to manage the sample from draw to assay, streamlining handling and ensuring sample preservation, integrity, and consistency.

With real-time sample processing occurring in over 50 countries on 6 continents, we are able to manage the sample from draw to assay, streamlining handling and ensuring sample preservation, integrity, and consistency.

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Custom Cell-Based Assays
Price on request

We build our custom cell-based assays using cell lines or primary cells (both normal and patient-derived). We also deliver novel ligand-binding assay approaches for greater ease of validation and scalability. Our assays are run routinely to support preclinical and clinical studies.

We build our custom cell-based assays using cell lines or primary cells (both normal and patient-derived). We also deliver novel ligand-binding assay approaches for greater ease of validation and scalability. Our assays are run routinely to support preclinical and clinical studies.

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Bioinformatics
Price on request

Whether you have high-throughput genomic data or high-content data for immune monitoring, we can meet the challenges of managing, analyzing, and synthesizing it to accelerate new discoveries, identify drug targets, characterize MoAs, and develop biomarkers for patient selection. This work is grounded in passion: For translational... Show more »

Whether you have high-throughput genomic data or high-content data for immune monitoring, we can meet the challenges of managing, analyzing, and synthesizing it to accelerate new discoveries, identify drug targets, characterize MoAs, and develop biomarkers for patient selection. This work is grounded in passion: For translational informatics and data science. For genomics and computational biology. For biostatistics. Throughout, we accelerate decision making by leveraging our translational informatics platform, PATH™.

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Antibody Services
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Human Plasma and Serum
Starting at $80.00 per unit

Human Normal Plasma, 10 mL

Human Normal Plasma, 10 mL

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Human
Diseased Human Peripheral Blood Mononuclear Cells (PBMCs)
Starting at $550.00 per unit

Available in 10M for: Acne, Asthma, Celiac Disease, CLL, COPD, Crohn's Disease, Diabetes Type I&II, HIV, HIV Treatment Naive, HIV-2, Lupus (SLE), Psoriasis, Rheumatoid Arthritis, Ulcerative Colitis

Highly annotated cryopreserved PBMCs are available from inventory. Data includes donor demographics, date of diagnosis, and... Show more »

Available in 10M for: Acne, Asthma, Celiac Disease, CLL, COPD, Crohn's Disease, Diabetes Type I&II, HIV, HIV Treatment Naive, HIV-2, Lupus (SLE), Psoriasis, Rheumatoid Arthritis, Ulcerative Colitis

Highly annotated cryopreserved PBMCs are available from inventory. Data includes donor demographics, date of diagnosis, and current medications.

Available in 10 million cells/vial
At least three lots in inventory from each disease state
Match plasma aliquots available for each lot
HLA Class-I and Class-II information available

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Clinical Immune Monitoring
Price on request

Tailored solutions—from custom assays to standard panels across multiple platforms—implemented at a global scale to achieve your trial objectives

Tailored solutions—from custom assays to standard panels across multiple platforms—implemented at a global scale to achieve your trial objectives

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Human Pan-T Cells
Starting at $395.00 per unit

Human Pan-T Cells, Negatively Selection, 5 million

Human Pan-T Cells, Negatively Selection, 5 million

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Human CD8+ T-Cells
Starting at $350.00 per unit

Human CD8+ T-Cells, Negatively Selected, 5-8 million

Human CD8+ T-Cells, Negatively Selected, 5-8 million

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Human CD4+ T-Cells
Starting at $350.00 per unit

Human CD4+ T-Cells, Negatively Selected, 5-8 million

Human CD4+ T-Cells, Negatively Selected, 5-8 million

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Human CD19+ B-Cells
Starting at $395.00 per unit

Human CD19+ B-Cells, Negatively Selected, 5-8 million

Human CD19+ B-Cells, Negatively Selected, 5-8 million

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Diseased Human Leukopak
Starting at $2,995.00 per unit

Our facilities have access to donors with various disease states including COPD, Diabetes Type I&II, HIV, Lupus, Rheumatoid Arthritis, Crohn’s Disease, Celiac Disease, Ulcerative Colitis, Diabetes, Multiple Sclerosis and other autoimmune disorders.

Half-packs available
Average 4 billion leukocytes
Option to characterize by HLA Class I & Class II available

Our facilities have access to donors with various disease states including COPD, Diabetes Type I&II, HIV, Lupus, Rheumatoid Arthritis, Crohn’s Disease, Celiac Disease, Ulcerative Colitis, Diabetes, Multiple Sclerosis and other autoimmune disorders.

Half-packs available
Average 4 billion leukocytes
Option to characterize by HLA Class I & Class II available

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Normal Human LeukoPak
Starting at $1,995.00 per unit

Fresh Human Leukopak, Normal, Full Pack

Each leukopak has roughly 10 billion leukocytes and up to 200 to 300 mL of matched plasma from a single healthy donor.

Full and half-packs available
Average 10 billion leukocytes
Option to characterize by HLA Class I & Class II available

Fresh Human Leukopak, Normal, Full Pack

Each leukopak has roughly 10 billion leukocytes and up to 200 to 300 mL of matched plasma from a single healthy donor.

Full and half-packs available
Average 10 billion leukocytes
Option to characterize by HLA Class I & Class II available

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Clinical Chemistry
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Cell-Based Assays
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Computational Modeling
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Cell Viability & Proliferation Assays
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Clinical Immunology Tests
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Biostatistics & Bioinformatics
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Bioanalysis
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Protein Quantification
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Biospecimens
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Protein Services
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Experimental Design
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Pharmacology & Toxicology
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Human Primary Cells
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Immune Cell Assays
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Cell-Based Screening Methods
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Project Management, Consulting, & Support Services
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Human Biospecimen Collection
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Immunoassays
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Antibody/Antigen Detection Based Testing
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Biology
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Clinical Research
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Equipment
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Clinical Laboratory Services
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Specialized Cell-Based Assays
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Biospecimen Management and Storage
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Functional & Cell Type Specific Assays
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Human Biospecimens
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Biochemistry & Molecular Biology
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Data Management
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Biomarker data management is a key step in every clinical bioinformatics study. Approximately 40% of the overall analysis time is dedicated to these tasks, which are crucial for the quality of the overall analysis.

Biomarker data management involves the integration and consistency checking of data collected from different... Show more »

Biomarker data management is a key step in every clinical bioinformatics study. Approximately 40% of the overall analysis time is dedicated to these tasks, which are crucial for the quality of the overall analysis.

Biomarker data management involves the integration and consistency checking of data collected from different domains. These can range from patient data provided by the clinics, to data generated in the lab by biological analysis platforms. The data management solutions developed by Quartz Bio allow to flexibly integrate data from different origins and formats. Consitency checks are then performed by analysts with a biotechnological knowledge of the data. All the data management processes are documented, auditable and reproducible. Robust data management ensures that the data analyses are developed on a solid ground.

Biomarker data management involves different steps:

  • Parse of the different files and integration into a “biomarker database”
  • Verification of the consistency of the identifiers (subject ids, visits, biomarkers, etc) across the different datasets
  • Standardisation of the variable names
  • Check of formats and variable ranges (compared to data specifications)
  • Derivation of variables specific to the biomarker data analysis

Quality Control

Biomarker data are heterogeneous. Technology-specific quality controls must be applied in order to identify possible sources of bias that could impact the analysis. The biology behind the assay and the sample logistics in clinical settings are two of the most important factors that can impact the biomarker data quality.

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Cells and Tissues
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Sequencing Experimental Design
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Each drug discovery program and each company has its own processes. Furthermore, it is not rare that multiple partners and collaborators are involved.

At Quartz Bio, we can also bring our biological and computational expertise to customize methods and applications to your own needs to facilitate data management and subsequent... Show more »

Each drug discovery program and each company has its own processes. Furthermore, it is not rare that multiple partners and collaborators are involved.

At Quartz Bio, we can also bring our biological and computational expertise to customize methods and applications to your own needs to facilitate data management and subsequent analysis.

Non exhaustive list of Methods development projects developed at Quartz Bio:

  • RNASeq quality control pipeline
  • Fluidigm qPCR data analysis pipeline and R package
  • Pipeline for analysis of immune-repertoire sequencing data
  • Data extraction form back-log of PDF files
  • Query and visualization tool for genotoxicity tests database
  • Transmart DB maintainer for EU industrial programs
  • Evaluation of bioinformatic databases
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Cytometry
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Biomarker Study Design
Price on request

In every study, the design is key. It is particularly true in exploratory biomarker studies, where statistical power cannot be controlled and where sample logisitics can have an important impact on input data quality and availability.

Quartz Bio data scientists have analysed numerous biomarker studies and have experienced many... Show more »

In every study, the design is key. It is particularly true in exploratory biomarker studies, where statistical power cannot be controlled and where sample logisitics can have an important impact on input data quality and availability.

Quartz Bio data scientists have analysed numerous biomarker studies and have experienced many cases where design flaws impacted negatively the analysis.

This expertise is routinely used a posteriori in the Quality Control process, but could also better be used before generating the data, i.e. at the design stage. Thus, reviewing the exploratory part of the Clinical Study Protocol and affiliated documents such as Analytical Plans or Manual of Operations could permit optimising the biomarker study design.

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Human Whole Blood & PBMCs
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Data Services
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Flow Cytometry Data Analysis
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In vitro Immunogenicity Assays
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Biomarkers
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DNA Sequencing
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DNA Sequencing Services

DNA Sequencing Services

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DNA
Price on request

DNA Services

DNA Services

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Nucleic Acid Services
Price on request

Nucleic Acid Services

Nucleic Acid Services

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2018-03-13 16:36:16 -0500

Net Promoter Score of 9 received for Normal Human Peripheral Blood Mononuclear Cells (PBMCs).

Additional Ratings: satisfaction with deliverable: 9, satisfaction with timeliness: 9.

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