Custom service capabilities
PBL’s Custom Service capabilities comprise three major areas: custom assay development, custom reagent development, and consulting services.Why choose PBL?
- Working together with many of the top pharmaceutical and biotechnology companies in the world, PBL has developed custom ELISAs, cell-based assays, custom reagents, and business strategies that have yielded savings to our clients and partners of millions of dollars in preclinical and clinical development costs.
- As the worldwide leader in interferon protein, antibody, and ELISA supply, PBL has key assets on hand to expedite the development of your customized assays and reagents. In many cases, we may expedite development of your assay by modifying a current PBL assay to meet your immediate needs.
- PBL is uniquely experienced with interferons, and specifically able to practice worldwide under our own intellectual property and extensive in-licensed IP.
- PBL’s scientific teams have developed and optimized a wide range of protein purification schemes, enzymatic, immuno-, and bioassays tailored to a variety of detection methods and assay formats, and have capitalized upon our unique expertise in the interferon field to develop world class assays.
- PBL offers customized multiplex assay services utilizing a solid-phase ELISA platform.
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What are PBL’s Custom Assay Service capabilities and how does PBL provide value to clients and partners?
PBL offers Custom Assay Development Services encompassing two primary fields: cell-based bioassay development, and mass-based immunoassay development such as ELISA. Our experience in the development of bioassays and ELISAs for IFNs and other cytokines can expedite your work in several crucial areas of research and drug development.The following examples focus on PBL’s specialization in IFN-based assays. PBL is also ready to help biotechnology and pharmaceutical companies develop cytokine and customized multiplex assays to maximize the data you can obtain from precious serum and plasma samples. PBL scientists have developed and/or customized cell-based assays using human, non-human primate, feline, rat, mouse, and pig cell lines and cytokines, and developed ELISAs to quantify cytokines from most of these species.
Example assay services
Mass based/ELISA/immunoassay development
- Quantifying IFN protein administered to subjects (Pharmacokinetics, PK)
- Quantifying IFN induction (or suppression) as marker of drug (NCE, NME) or monoclonal antibody (MAb) efficacy (Pharmacodynamics, PD)
- Quantifying IFN induction (or suppression) as marker of off-target effects of NCEs and NMEs (Toxicology)
- Quantifying several analytes in a multiplex, solid-phase, immunoassay format incorporating the analytes of your selection
- Use of direct, sandwich, and competitive ELISAs to address the research goal
- Assay optimization for increased sensitivity and improved range
- Quantifying protein complexes (assessing free vs. bound cytokine in biological samples)
Cell-based bioassay development
- Screening of compounds and protein-based therapeutics that induce or inhibit IFN activities
- Examining inhibition of viral cytopathic effects (CPE) in cell-based assays specific to subject species (human, bovine, porcine, canine, NHP, rodent) to minimize experiments in animal subjects and humans
- Examining antiproliferative effects in cell-based assays specific to test subject species
- Examining alterations in IFN and cytokine activities in response to formulation changes, delivery system manipulations, and chemical modification (e.g., PEGylation)
- Development of cell lines and reporter gene systems to monitor the activity of the molecule of interest
- Neutralization of protein bioactivity by antibodies (serum or plasma samples, or purified antibodies) relevant, for example, to identification of bioactive MAbs and to monitoring of cytokine immunogenicity
Mass-based and cell-based assays are qualified by the following parameters where relevant:
- Specificity / cross reactivity
- Analytical range / dynamic range
- Matrix effects (Serum, plasma, tissue culture media, etc.)
- Stability
- Reproducibility
- Precision (inter- and intra-assay variability)
- Spike recovery in appropriate matrices
- Calibration to international standards or relevant species-specific standards
- LLOD
- LLOQ
- SOP and protocols
In addition, we offer
- Development of bioassays suitable for use under GLP
- Development of ELISAs and immunoassays suitable for use under GLP
What are PBL’s Custom Reagent Development capabilities?
PBL’s Custom Reagent Development Services are focused on the production of interferons and cytokines of various species (human, non-human primate, rat, mouse, feline, canine, and farm animal interferons), antibodies derived from these proteins, and modified antibodies. Our scientists have experience in all phases of reagent development.Reagent development capabilities
- Recombinant protein and enzyme production in bacterial and mammalian cell expression systems
- High milligram-scale production from bacterial expression system
- Purification of cytokines from bacterial and mammalian cell-based expression
- Purification of monoclonal antibodies from ascites and tissue culture media
- New hybridoma, monoclonal, and polyclonal antibody development
- Antibody conjugation to fluorescent and colorimetric labels; development of novel immunological tools
- Expression and purification of human, non-human primate, rat, mouse, feline, canine, and farm animal interferons
- Stabilization of large molecule analytes and protein standards
In addition, we offer
- Custom development of eukaryotic expression systems cytokines to enable
- High milligram- and gram-scale protein production and purification from eukaryotic expression systems
Why does it make sense to work with PBL?
We partner closely with our client companies to ensure that your needs are met. In addition, PBL’s custom reagent and assay development services are performed under strict non-disclosure terms and follow a multistep, milestone-based process. At each step, we keep you informed of progress toward milestones with frequent updates to ensure your satisfaction and request feedback.- Staging of development
- Feasibility to proof of concept
- Development and Optimization
- Quality review
- Semi-automated manufacturing of ready-to-use kits
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