Precision for Medicine
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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). Precision for Medicine large inventory of extensively characterized cryopreserved cells are ready for immediate delivery. Human Peripheral Blood Mononuclear Cells (PBMCs) and purified cell subsets are available from healthy and donors with a variety of medical conditions: autoimmune, infectious disease and cancers. Precision can provided custom curated specimens based on your specific desired donor and cell population. Our other 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. fully integrated CRO devoted to oncology and rare disease. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker solutions, and an unequivocal passion for rare diseases and oncology.
Fresh, FFPE and FF (snap frozen) tissues in sections, blocks or slides.. Tissues available include human adult, human diseased and tumor tissues. Both cancer and normal adjacent tissues are available in frozen and FFPE specimens for each donor.
**Normal Human PBMC Purified, Characterized, 10 Million cells/vial and 50 Million cells/vial post-thaw. Cryopreserved and available for immediate purchase Basic demographics: age, gender, ethnicity, height, weight 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 Tested negative for HIV, HBV, and HCV
Precision provides a wide range of material type collections including apheresis, whole blood, plasma, serum, urine, saliva, sputum and tissues. All specimens are collected with informed consent and under IRB approved protocols. Access to collect samples from the following indications:
Alzheimer’s Disease
Cancer
Cardiovascular Disease
Crohn’s Disease
Diabetes
Endocrine Disorders
HPV
HBV
HCV
HIV/AIDS
Lupus
Multiple Sclerosis (MS)
Psoriasis
Rheumatoid Arthritis
and more
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
PBMCs from donors with Acne, Asthma, Celiac Disease, CLL, COPD, Crohn's Disease, Diabetes Type I&II, HIV, Lupus (SLE), Psoriasis, Rheumatoid Arthritis, Ulcerative Colitis available in inventory. Available in 10 million cells/vial Data includes donor demographics, date of diagnosis, and current medications HLA Class-I and Class-II information available Match plasma aliquots available for each lot.
Precision can isolate a wide range of specimen material types, including leukopaks, whole blood, and cord blood, from both healthy and diseased donors into PBMCs, cell subsets such as Monocytes, CD4+ T-cells and NK cells in large quantities and cryopreserved.
Human CD8+ T-Cells, Negatively Selected, 5-8 million
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.
Average 10 billion leukocytes
Option to characterize by HLA Class I & Class II available
Human CD19+ B-Cells, Negatively Selected, 5-8 million
Frozen human normal and diesease state plasma. Bulk serum/plasma.
Human CD14+ Monocytes, Negatively Selected, 5-8 million post-thaw per vial
Basic demographics: age, gender, ethnicity, height, weight
FACs purity analysis for purified PBMC subsets
Tested negative for HIV, HBV, and HCV
Flow cytometry (and immunophenotyping) for high-throughput, multi-parameter analysis of cell subsets (up to 18 colors, research, and CLIA).
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.
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.
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.
We provide services under GLP and FDA guidelines for:
• ELISA based assays
• Cell based immunoassays
Capabilities:
Equipment:
-Perkin Elmer, Envision/Enspire
-Multi-channel pipets
Number of samples processed in a single experiment: 72
Typical turn-around: 5 days
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.
Rapidly harmonize, synthesize, and visualize specialty lab data from multiple vendors and diverse assays.
ELISpot testing across multiple phases of clinical trials
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
Neutralizing antibody (cell- or non cell-based)
Cell viability, apoptosis / necrosis
Human Pan-T Cells, Negatively Selection, 5 million
Reporter gene analysis GPCRs function
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.
ELISpot testing across multiple phases of clinical trials
via flow cytometry (up to 18 colors, research, and CLIA)
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™.
T- and B-cell proliferation
Immune function (T, B, NK, NKT, Treg, Neutrophils)
Tailored solutions—from custom assays to standard panels across multiple platforms—implemented at a global scale to achieve your trial objectives
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:
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.
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:
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.
DNA Sequencing Services
DNA Services
Nucleic Acid Services
Statistical Analysis Services
Pharmacology Services
Genotyping Services
Immunostaining Services
Protein Expression Visualization Services
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