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Custom Monoclonal Antibody Development

Using Molecular Devices™ suite of cell selection and characterization technology, our experienced team Develops High-Value Hybridoma Clones. 

Kemp Proteins accelerates your novel antibody discovery timelines through one-step cloning technology. After electrofusion, single cells are plated into semi-solid HAT selection media and grown in isolation, forming discrete colonies. Individual colonies are then robotically picked based on preset clonality parameters, IgG/IgM expression, and antigen specificity eliminating lengthy limiting dilution or FACS screening steps. 

Our ClonePix2™ uses both white-light and fluorescence to pick 10,000 “best fit” hits / day”. Rapid screening of thousands of clones increases the probability of finding optimal producers exponentially allowing Kemp Proteins to develop and isolate application-specific antibodies to your targets. 

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Custom Monoclonal Antibody Development Process:Custom Monoclonal Antibody Development

Start your custom monoclonal antibody development project discussions, request a quote.

Antibody Techniques:

Kemp’s team of protein problem-solvers uses Köhler and Milstein’s teachings as the basis for custom monoclonal antibody development. The result is successful projects that generate client specified application-specific antibodies. We have developed additional in-house know-how and invested in an experienced team of hybridoma specialists. This team uses modern instrumentation for robotic picking, cloning, high-throughput screening, and characterization, to develop and supply our clients with application-specific antibodies. Our team initiates every custom monoclonal antibody project with a pre-project consultation. This enhances our understanding of your needs and expectations prior to starting. Our application team is supported by a program management and an ISO 9001-compliant Quality Management System, Your project  is our priority!

Kemp’s hybridoma experts have many years of hands-on experience developing murine hybridoma secreted antibodies. Our team has developed and identified thousands of application-specific antibodies that meet the needs of our diverse base of R&D clients working in biotechnology, pharmaceuticals, diagnostics, and government and academic labs. This experience is used to optimize your project resulting in a successful outcome. Together we will optimize your antigen design and develop screening strategies designed to meet your custom monoclonal antibody development goals

Our goal is to provide our clients with custom monoclonal antibody development services that deliver the application-specific antibody required to enable them to meet their R&D targets. Let us help you accelerate your custom mab development, request a quote now!

Hybridoma Generation Details:

Antigen Types:
  • Proteins
  • Peptides
  • Small Molecules
  • Polysaccharides
  • Whole Cells
  • Extracellular Domains
  • Plant Extracts

Functional Applications:
  • Std. Assays – EIA, WB
  • Cell Sorting & Staining
  • Anti-Idiotypic
  • Immuno-MRM
  • PTM-specific
  • Crystal Structure
  • LFA, IFA, IHC, IP

Core Support:
  • Project Management
  • ISO 9001:2015 Accredited
  • Technical Support
  • 1st class Client Service
  • Milestone-Invoicing
  • IP-Free
  • AAALAC accredited

Types of Antibody Development Projects:

Kemp Proteins uses in-depth expertise, cutting-edge equipment, and a modern purpose built accredited facility to rapidly generate application-specific monoclonal antibodies (mAbs). Kemp Proteins customizes project strategies to identify top mAb candidates for final assay(s). Standard projects include:

Standard Reagents/Antibody Tools

Rapid monoclonal antibody development to generate mAbs for basic research in immunoassays: Kemp Proteins can target proteins, peptides, small molecules, and other antigens to make mAbs as antibody tools. mAbs are identified for binding utility and can be characterized for antibody production and binding affinity.

Diagnostics & Research Use Only (RUO)

Custom-designed mAb development strategies tailored to specific diagnostic programs: Our Kemp team will discuss and agree program goals with clients prior to developing a specific plan to provide application -specific mAbs for use in diagnostic, lab-developed and RUO assays. In addition to providing mAbs according to the client agreed plan, Kemp can provide clients extensive mAb characterization studies that include confirmation of specificity by ELISA (target and counter-screens antigens) competitive ELISA assays, and Octet-based screening for antibody binding affinity and epitope binning (mAb pairing) to identify top candidates. The Octet system enable us to perform high-throughput, real-time, label-free affinity and kinetic characterizations (for more information see our affinity services) We develop mAbs to small molecules, secreted proteins, peptides, and cell-surface proteins.

Therapeutics

Custom-designed mAb development strategies tailored to specific therapeutic programs: Our Kemp team will discuss and agree program goals with clients prior to developing a specific plan to provide mAbs for therapeutic related programs. In addition to providing mAbs according to the customized plan, Kemp can provide functional and characterization assays that include flow cytometry, blocking and non-blocking assays, competitive ELISA assays, Octet-based screening for binding affinity and IgG quantitation. The Octet system enable us to perform high-throughput, real-time, label-free affinity and kinetic characterizations (for more information see our affinity services) Specialized functional assays can be incorporated into the screening strategy to maximize the selection of application-specific mAbs. Kemp Proteins develops mAbs to small molecules, secreted proteins, peptides, and cell-surface proteins.

Anti-Idiotypics

Custom-designed strategies to develop anti-idiotypic mAb tools tailored to specific antibody-based drug programs: Our Kemp team will discuss and agree program goals with clients prior to developing a specific plan to provide mAbs to characterize antibody drug candidates. Kemp Proteins can identify mAbs for use at critical points of pre-clinical and clinical therapeutic drug development including pharmacokinetic studies, anti-drug antibody (ADA) identification, and bridging studies. In addition to providing mAb tools according to the customized plan, Kemp can provide functional and characterization assays that include matrix interference assays (plasma or serum), blocking and non-blocking assays, competitive ELISA assays, Octet-based screening for binding affinity and IgG isotyping/quantitation, to identify top candidates. Kemp Proteins develops anti-idiotypic mAbs to human IgG drugs, bispecific drugs, nanobodies, and scFv antigens.

Immuno-MRM

Custom-designed mAb development strategies tailored to specific immuno-MRM programs: Kemp Proteins develops strategies for identification of high-affinity, anti-peptide mAbs for MRM detection of endogenous tryptic fragments, including specific strategies for peptide design, modified immunization, and screening to identify top candidates for a specific application. To help identify top candidates for immuno-MRM applications, our team undertakes characterization using direct ELISA with multiple parameters, competitive ELISA screening, IgG quantitation, and final assay screening.

Neo-Epitopes

Custom-designed mAb development strategies tailored to specific programs targeting neo-epitopes: Kemp Proteins develops strategies for identification of neo-epitopes, including specific strategies for peptide design and multiple antigen screening to identify top candidates for a specific application. To help select top mAb candidates that are neo-epitope specific, our team undertakes characterization using direct ELISA with multiple parameters against peptides and proteins (truncated and full-length).

Important Considerations When Developing Your Custom Antibody

Commencing any custom monoclonal antibody development project, whether a standard reagent or a therapeutic, requires thorough understanding and design of the antigen to be used in the immunization process. The Kemp team uses a consultative approach with clients to gain a clear understanding of their goals and to provide guidance regarding optimum immunogen and immunization strategy. Our basic principles are:

  • Develop a good immunogen: We can synthesize the immunogen in-house through our gene-protein service, or we can assist clients in identifying an appropriate contract peptide design service.
  • Use a proven and reliable immunization strategy: Our team has developed and used many immunization strategies. For reliable and effective results, we usually recommend our proprietary Repetitive Immunization at Multiple Sites (RIMMS) system.
  • Use electrofusion to generate thousands of clones vs. limited numbers obtained using traditional PEG fusion: We then use robotic fluorescent high-throughput Picking for rapid selection of antigen-specific, high-producing clones with clonality assurance provided by high-resolution pictorial evidence of single-cell clonality.

Start your custom monoclonal antibody development project discussions, request a quote.

Custom Monoclonal Antibody Development Process:

Target Analysis / Project Strategy

Immunization using an appropriate immunogen is critical in the custom monoclonal antibody development of application-specific antibodies. Proper selection and validation of the antigen is important for developing a specific immune response and for selecting antigen and utility-specific hybridoma clones. To determine optimal project strategy, Kemp Proteins recommends discussing custom monoclonal antibody development goals and details—including final application of the mAbs, nature of the antigen in the sample of the intended assay, desired sensitivity, and other factors—prior to project initiation.

Antigen Design

As your gene-to-protein partner, Kemp Proteins can help you express your protein, design your peptide, and discuss with you the advantages and disadvantages of different antigen options.

Mouse Immunization

Kemp Proteins typically immunizes 3 to 5 mice per project using our proprietary Repetitive Immunization at Multiple Sites (RIMMS) protocol, which generates a robust immune response to a variety of immunogens in an accelerated timeframe. Kemp Proteins can obtain a high titer of antigen-specific hyperimmune serum in about 3 to 5 weeks. We typically generate a strong, specific Ab titer sufficient for fusion (A620 > 0.5 at serum dilution of 1:100,000) by the initial serum collection. If needed, we will perform additional boosts to increase the specific Ab titer.

Electrofusion

Lymphocytes are harvested from mouse/mice exhibiting the highest titer for fusion. Lymphocytes are fused using electrofusion technology. Electrofusion provides a superior fusion efficiency (>10-fold) compared to traditional PEG-mediated fusion. From a typical electrofusion, up to 10,000 hybridoma cells can be generated consistently, providing ample hybridoma clones to be screened from a single fusion.

Direct Cloning & Imaging

Kemp Proteins operates a full suite of cutting-edge molecular device equipment: Clonepix2 (florescent robotic picking) & Imager (clonality assurance). Post-fusion cells are plated in a methocellulose-based, semi-solid cloning culture medium containing HAT, a selection reagent that prevents B-Cells and Myeloma cells from growing while allowing hybridoma cells to grow. Colonies of clonal hybridoma cells emerge in the semi-solid media. Our clone-picking process integrates imaging, robotics, and digital image analysis software for selecting clonal hybridomas and uses stringent picking clonality parameters, IgG expression, and/or antigen specificity to optimize the selection of stable hybridoma clones for screening. The use of the CloneSelect Imager provides a series of images to provide clonality assurance.

High-Throughput Screening (HTS)

Hybridoma clones generated as part of custom monoclonal antibody development are screened using an application-compatible method. Kemp Proteins can utilize a variety of screening methods to identify target antigen-specific clones that will be useful in the intended assay including ELISA-based, fluorescence-based, Octet-based, or a combination of methods. If the antibodies are used for binding to the antigen in solution, an in-solution screening method such as Octet based screening is available. If the antibodies are used for cell-surface antigen recognition, flow cytometry screening is incorporated.

Culture Supernatant

Kemp Proteins can provide clients supernatant from all confirmed positive clones for testing and selection of final clones. Approximately 3-5 ml of hybridoma supernatant is harvested and delivered.

Antibody Characterization

Additional antibody characterization is an important step in identifying top mAb candidates. Kemp Proteins offers scouting affinity of mAb candidates by Octet to characterize mAbs for candidate ranking. Epitope binning in a label-free sandwich immunoassay is another critical characterization we include in custom monoclonal antibody development strategies to help identify mAb pairs.

Cell Banking

Kemp Proteins expands and freezes at least 5 vials of frozen hybridoma cells per selected clone. The vials are cryopreserved in a 10% DMSO freezing media. Use of serum-free freezing media is available on request.

Production & Purification

Many Kemp clients choose to jump-start their research projects with a small-scale (5 mg) production as part of the initial project. Once they have determined the antibody (ies) of choice, our team will scale production from 10 mg to gram levels using various modes of in vitro systems production. Purification is performed on a Bio-Rad NGC system or AKTA Pilot purification system using pre-packed protein G or protein A columns. Additional antibody characterization steps can be incorporated on request, such as analytical SEC, IEF, and SDS-PAGE testing for purity, ELISA testing (if applicable) for binding, and any additional characterizations that were undertaken. A signed Certificate of Analysis is provided for each production.

Converting Hybridoma to Recombinant

Some clients decide to sequence and convert the hybridoma to recombinant. For details, please visit our Hybridoma-to-Recombinant Conversion.

Start your custom monoclonal antibody development project discussions, request a quote.

FAQ for Custom Monoclonal Antibody Development:

Can you help us make our our antigen? How much antigen is required for hybridoma development?

Yes! Kemp Proteins offers free antigen design (gene to protein or peptide design) consultation to ensure that optimal antibodies will be developed. Kemp can make mg or even gram(s) batches, if you need additional material for your projects.

If you are providing the protein for the hybridoma development project, we need 0.5 – 2 mg. The preferred buffer is PBS with a protein concentration around 1 mg/ml.

What is the shipping address for Kemp Proteins?

Kemp Proteins, LLC

5119 Pegasus Court, Suite P

Frederick, MD 21704

Attention: Hybridoma Development

What type of mice are used for the projects?

The type of mouse will be determined by the type of project.  We usually recommend SJL/J, though we also use Balb/c, Swiss & other commercially available strains by our approved vendors.

What types of screening can be performed for the projects?

Kemp Proteins utilizes automated high throughput screening and analytical technology to consistently deliver monoclonal antibodies that meet client’s acceptance criteria.  We perform Octet Screening, High Throughput Flow Cytometry, Biacore Analysis, Direct ELISA, Indirect/Capture ELISA, Competition Assays (blocking/Non-blocking assays) at an additional cost.

 

How does Kemp ensure that the hybridoma clones are stable?

Cloning Hybridomas prior to screening and the series of tests to confirm binding activity.  We also can use the Molecular Device Imager to document clonality.

What are the growing conditions of clones?

Culture conditions will be shared as the hybridoma clones are sent as a deliverable.

Can Kemp Proteins help us produce and purify the first batch of antibody from the hybridoma?

Yes and future batches as well! We will supply the antibodies in PBS without preservatives such as azide or protein stabilizers such as BSA.  They will be grown serum-free. The endotoxin levels will be < 2EU/mg, which qualifies them for most in vivo studies. To meet the most stringent requirements, we can produce proteins with lower endotoxin levels: <1EU/mg

Is there Intellectual Property (IP) associated with the projects?

Kemp Proteins is a fee for service CRO.  We provide phase in pricing to reduce your risk and only invoice for services performed.  All clones and antibodies derived from hybridoma clones are the property of our customers.  Kemp Proteins holds no intellectual property rights.

Why Kemp Proteins for hybridoma development?

Kemp Proteins’ experienced team of hybridoma specialists utilize modern robotic picking, cloning, screening, and characterization instrumentation to develop and supply the antibody you need. Supported by a program management team and a Quality Management System that has been designed to be ISO compliant, our experienced hybridoma team use a process of pre-project consultation to ensure we understand your needs and expectations prior to starting any development project. We communicate with you throughout the entire process and deliver application-specific antibodies to help you succeed and advance your own programs. Our goal is to be the best antibody development company and partner for our clients.

Custom Monoclonal Antibody Development Service Quote Request

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