Cell Analysis & Reagents

Delivering Cell Analysis Services

The BD Biosciences Custom Technology Team (CTT) is a specialized contract research group with core competencies in flow cytometry and multiplexed protein assay development. CTT offers custom products, contract manufacturing, assay development, and assay services that enable global biotechnology, pharmaceutical, and contract research organizations to respond efficiently to the rapidly changing landscape of research and development.

Overview Design Delivery

CTT works as an extension of a client’s team to provide custom products that can be quickly and seamlessly implemented once the client brings them in house.

CTT solutions expand beyond typical offerings to essential resources such as protocol development, flexible delivery options, and quality documentation.

To meet specific research needs, CTT offers several flexible manufacturing and packaging options for custom products, including manufacturing in a cGMP facility. Lyophilized products uniquely suited for multisite or longitudinal studies are also offered, including antibody cocktails and cells.

For clients with limited capacity or limited experience in flow cytometry and multiplexed protein assays, comprehensive custom services are offered that include sample preparation, analysis, and data reporting. Highly trained members of CTT have processed thousands of clinical trial samples in various studies.

Design CTT Progress

The Custom Technology Team begins all design work with an across-the-board review of technical and logistical project needs.

First, the team conducts a detailed review of the study objectives and assay requirements. Then, to understand capacity constraints and in-house proficiencies, CTT examines instrument and personnel resource capabilities. Last, the team considers logistics such as custom product or data delivery preferences and information technology infrastructure.

By working to understand client needs and requirements, CTT designs custom products and delivers data that can be seamlessly deployed in house.

Flexible options for feasibility and optimization

CTT can adapt feasibility and optimization to meet specific research needs. Clients can specify the type of sample or cell line to be used and provide external reagents for conducting tests. Additionally, for large-volume production requirements, CTT can accommodate an evaluation and trial period for in-house testing before production is scaled up.

A deep knowledge base for advanced concept development

CTT is conversant in current methodologies for cell and protein analysis. This knowledge base allows CTT to provide expert guidance on the selection and design of state-of-the art assays, helping clients to quickly advance their research programs.

With each project, CTT subject matter experts conduct literature reviews, consult with other specialized experts, and review in-house data. CTT can also leverage the expertise of BD Biosciences product development researchers to make product and assay recommendations, giving clients the edge that comes with accessing tomorrow’s technology today.

Clients will receive an overview of available methodologies for each project and detailed recommendations on the optimal approach.

The Custom Technology Team aims to provide a packaged solution to clients to streamline in-house implementation.

Typical custom products include pre-optimized antibody cocktails or multiplex bead reagents, buffers, and controls. To reduce guesswork, the team can provide a comprehensive study report detailing reagent materials and sample data. Also, the team can recommend protocols, instrumentation, and analysis methods.

Flexible custom product options

CTT offers several versatile manufacturing and packaging solutions for custom products to meet specific research needs. If required, custom products can be manufactured in a BD cGMP facility.

Clients can define packaging and labeling of custom products for easy handling and tracking of reagents in the lab. CTT offers unique packaging options such as lyophilization of antibodies, antibody cocktails, immunological proteins, and cells to improve standardization and reduce hands-on time.

CTT provides central order tracking with transparent due dates and tight estimates for delivery to help maximize lab productivity. Standing orders and batch delivery can be set up for high-volume orders to allow clients to effectively manage inventory to reduce costs.

Typical assay services

CTT has conducted cell and protein analysis studies for many major biotechnology and pharmaceutical companies. Thousands of samples have been processed in various studies for cancer, autoimmunity, infectious disease, and HIV therapeutics and vaccines. Expertise in the typical study processes, combined with expertise in cell and protein analysis, can translate into efficient study completion for clients.

CTT can:

  • Develop a proposal that outlines the assays to be used
  • Develop study protocols and SOPs that optimize collection and transport conditions in coordination with research and logistical teams
  • Conduct feasibility studies using known positive and negative controls
  • Conduct qualification studies to assess sample-to-sample variation, transport stability, intra-assay variability, inter-technician variability, and normal range expectations
  • Receive, accession, and track study samples using established SOPs
  • Process and analyze study samples following assay protocols
  • Submit a cumulative data file and comprehensive bioanalytical study report providing all information necessary to properly interpret study results
Quality systems in place for assaying samples

The CTT ensures that industry best practices for quality are followed by instituting comprehensive quality control systems. The team also participates in the CAP (College of American Pathologists) Proficiency Survey for Flow Cytometry and Hematology.

  • All custom products are tested to lot-to-lot specifications to reduce batch variation. Pre- and post-bottle quality testing is employed. The BD Biosciences facility for custom product creation is ISO 9001:2000 certified.
  • Unique protocols for each individual study are tracked, ensuring that every sample is handled consistently and reliably. CTT personnel are trained to handle biohazards, and BD Biosciences maintains personnel training records.
  • Instruments are validated for use in human studies and equipment is maintained on a regular maintenance and calibration schedule. Storage devices are monitored daily to ensure proper sample storage conditions and maintain sample integrity.
  • Data is stored on a secure server and is password protected, and redundant copies of data are archived.
Overview Immunophenotyping Immune Function Lyophilized Products

To provide clients with state-of-the-art tools to advance discovery and development programs, CTT offers a deep knowledge base of advanced methodologies for immunophenotyping, immunogenicity testing of biological therapeutics, immune function testing, and more.

Overview of the CTT capabilities

Examples of assay services:
  • Immunophenotyping
  • Intracellular proteomics (BD™ Phosflow)
  • Cell surface proteomics (BD FACS™ CAP)
  • Immune function testing
    • Cellular response to antigens
    • Intracellular cytokine assays
    • ELISPOT to detect T-cell response
    • Flow cytometry–based proliferation assays
  • Receptor occupancy assays
Examples of custom products:
  • Antibody cocktails for multicolor flow cytometry
  • Premixed formulations for multiplexed protein quantitation assays (BD™ Cytometric Bead Array)
  • Preoptimized cytokine flow cytometry kits
  • Lyophilized flow cytometry reagents and control cells
Multicolor products

The Custom Technology Team works with clients to make both qualitative and quantitative multicolor antibody cocktails for flow cytometry–based immunophenotyping.

These products include conjugated antibodies, compensation controls, buffers, and protocol guidelines. Optimized multicolor flow cytometry cocktails can streamline sample preparation, acquisition, and analysis, and improve standardization between experiments.

Intracellular proteomics (BD Phosflow)

CTT offers assay optimization, sample processing, and data delivery for BD™ Phosflow analysis. An intracellular phosphoprofiling tool, BD Phosflow technology allows scientists to examine cellular subpopulations in complex samples such as primary cells, whole blood, or peripheral blood mononuclear cells (PBMCs). Unlike traditional methods such as Western blotting, BD Phosflow enables researchers to analyze phosphoprotein signaling in single cells through the use of multiple cell surface markers. Using BD Phosflow alone, researchers can uncover rare cell subtypes with different signaling mechanisms.

Cell surface marker profiling

For researchers using stem cells in drug discovery or cell therapy, CTT offers cell surface marker profiling to identify cell state variations indicative of donor-to-donor variations, cell type specific markers, or treatment-specific changes. The team leverages the novel proteomics tool BD FACS™ CAP (Combinatorial Antibody Profiling), a flow cytometry–based method that uses a broad screening panel of more than 200 high-quality fluorescently-labeled BD antibodies.

Immunophenotyping of regulatory T cells

Cell surface marker profiling

Multiple phosphoproteins in different cell types studied by BD Phosflow

Immunogenicity of biological therapeutics

The Custom Technology Team specializes in developing novel multiplexed protein assays for immune monitoring. These assays have been designed to measure humoral immune response to biological therapeutics and vaccine antigens, vaccine carrier proteins, as well as infection.

CTT uses the BD™ Cytometric Bead Array (CBA) as an assay platform for immune monitoring. This bead-based flow cytometry application allows users to quantify multiple proteins simultaneously. CTT has extensive experience working with pharmaceutical companies developing CBA-based antibody detection assays.

Intracellular cytokine assays

CTT offers flow cytometry-based intracellular cytokine assays and sample processing services for immune monitoring relevant for studies of autoimmune disease, HIV and tumor vaccine development, allergy, and viral and infectious diseases. These custom, premixed cytokine assays speed immune monitoring by providing data on multiple cytokines simultaneously on specific cellular subsets in complex samples. CTT’s intracellular cytokine assays also save precious sample, using only 0.5 mL of blood for multiple cytokine results.

Custom, premixed CBA kits

To help improve lab efficiency and standardization, CTT can provide researchers with premixed formulations of off-the-shelf CBA reagents and detection beads. CBA reagents are available for the detection of human, mouse, or rat cytokines and chemokines and growth factors from serum, plasma, or tissue culture supernatant samples.

A custom CBA assay designed by CTT to detect anti-epoetin alfa

ELISPOT services

Standardize and simplify multisite, longitudinal studies

The Custom Technology Team offers lyophilized products for flow cytometry, including reagents and control cells. Designed for specific experiment requirements, lyophilized reagents in pre-aliquoted formats can reduce variability between experiments, making these reagents ideal choices for multisite or longitudinal studies. Lyophilized reagents also have an extended shelf life compared to liquid reagents. In addition, researchers can easily incorporate lyophilized reagents into automated workflow processes, providing greater consistency and improved lab efficiency.

Researchers simply add sample—cells, blood, or other liquids—to rehydrate the biomolecules, and immediately begin experimental analysis. Lyophilized products can be packaged in many formats such as tubes, plates, and single vials.

Function equivalent to liquid reagents

Lyophilized cells as controls

For Research Use Only. Not for use in diagnostic or therapeutic procedures.

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