Creative Biolabs offers comprehensive immunologic analysis services for a wide range of biotherapeutic drug candidates, including protein, enzyme, antibody, an antibody-drug conjugate (ADC) and so on. Based on our experienced scientist team and elaborate technical platforms, we are capable of carrying out your assay with optimized and validated protocols in a fast and reliable manner.

Remarkable characteristics of prolonged half-life, high target specificity, and low intrinsic toxicity make biotherapeutic drugs significantly outperform small molecule drugs, and attract increasing attention in the global academic and pharmaceutical industrial field. However, the use of biotherapeutic drugs may lead to unwanted immune responses, resulting in the efficacy decrease of the drugs and even safety threaten to patients. It is worthwhile and necessary to conduct complete immunologic analysis for biotherapeutic drug candidates and biosimilar biologics at the early stage of drug development. By taking this into account, Creative Biolabs integrates four delicate platforms together to provide high-quality services packages to help clients evaluate their drug candidates, and the contents of our immunologic analysis services are listed below.

SIAT® Immunogenicity Assessment Services

The immune responses to biotherapeutic drugs can decrease the efficacy of the drugs due to faster clearance of the drugs as immune system treat them as antigens and launch specific immune reaction. Furthermore, unwanted immune system activation may cause rapid and enormous cytokine release and bring safety to threaten to patients. Therefore, it is of great importance to conduct Immunogenicity risk management of biotherapeutic drugs and biosimilar biologics in the preclinical stage. Creative Biolabs provides the proprietary Sensitive Immunogenicity Assessment Technology® (SIAT®) system to help clients evaluate the immunogenicity potential for a broad range of biotherapeutic drug candidates, and screen out optimal individuals.

Fig.1 Immunologic Analysis Services.

ECIA™ Cellular Analysis Services

As the ancillary service of SIAT® Immunogenicity System, Creative Biolabs offers ECIA™ cellular analysis services designed to accelerate your immune monitoring or epitope discovery projects in a cost-efficient way. Our customized ECIA™ cellular analysis platform can be a good choice for clients who are eager to acquire HLA allele information, to identify antigen-specific B cells and T cells, to detect Intracellular cytokine level as well as to monitor specific T cell proliferation. Based on our unique high-throughput technique, enriched experience, and professional service team, Creative Biolabs promises to provide the most suitable cellular assay design and deliver accurate reports with reliable data for each project.

CreMap™ Epitope Mapping & Discovery Services

Creative Biolabs has developed an excellent CreMap™ epitope mapping & discovery platform to help customers identify the specific binding sites of antibodies (or BCRs, TCRs) on target antigens, and those binding sites on antigens are so-called epitopes. The process of identifying epitopes of antibodies (or BCRs, TCRs) on certain antigen is known as epitope mapping, which plays a crucial role in the discovery of new biotherapeutic drugs, vaccines, diagnostic reagents, and so on. Our CreMap™ platform offers both B cell epitope mapping and T cell epitope mapping service to assist your research or drug discovery project in a cost-efficient way.

RDIT® De-immunization Services

Eliminating the immunogenicity of therapeutic proteins or biotherapeutic drugs is critical to improving clinical outcomes. Creative Biolabs has developed a well-mature RDIT® de-immunization platform to offer a number of assays to diminish the immunogenicity. In general, de-immunization can be accomplished by many strategies, such as amino acid modification, T/B cell epitope identification, as well as structure reconstruction. In addition, we have also generated a computer-based tool to produce non-immunogenic versions of potential targets. This tool can determine the immunogenic region of biotherapeutic molecules to identify specific analogs with low binding affinity.

Service Highlight

• Efficient and accurate immunogenicity evaluation
• Broad population coverage
• Fast and cost-effective evaluation
• A range of protein engineering capabilities

Creative Biolabs' technical experts will help you choose the best service to meet your specific needs. For more details on how we can provide innovative support to your project, please feel free to contact us.

Published Data

• Immunogenicity Analysis of MSP4 Protein

Fig. 2 Immune response in mice immunized with rPoMSP4. (Juliette Uwase, 2020)

The study explores the immunogenicity of Plasmodium ovale merozoite surface protein 4 (MSP4), highlighting its potential as a vaccine target due to its high conservation across different isolates and strong immune response in mice. The research demonstrates that MSP4 can induce both antibody and cellular immune responses, essential for effective vaccine development. Immunogenicity analysis in this context assesses the MSP4 protein's ability to elicit a robust immune response, crucial for its consideration as a part of a potential vaccine against malaria caused by P. ovale. This could lead to a broader protection in regions where this species coexists with other malaria-causing Plasmodium species.

FAQ

1. What is immunogenicity analysis, and why is it important in evaluating drug candidates?

   Immunogenicity analysis refers to the assessment of the potential immune response provoked by a drug candidate in the body. This analysis is crucial as it helps determine the safety and efficacy of drugs, particularly biologics, by evaluating whether a drug induces an undesirable immune response. Such responses can lead to reduced therapeutic efficacy, altered pharmacokinetics, and even adverse health effects. Understanding a drug's immunogenicity is essential for regulatory approval and successful market entry.

2. How do you predict and mitigate the immunogenicity of therapeutic proteins?
   • In Silico Analysis: Utilizing bioinformatics tools to predict epitopes that might trigger immune responses.
   • Deimmunization: Modifying potential immunogenic regions in the protein to reduce immunogenicity without affecting therapeutic activity.
   • Tolerance Induction Strategies: Designing administration protocols that can induce immune tolerance to the therapeutic protein.
   • Formulation Adjustments: Optimizing the formulation of the drug to minimize protein aggregation and degradation, which can trigger immunogenic responses.
   • These approaches are integrated into the drug development process to reduce potential immunogenicity early on.
3. What factors influence the immunogenicity of biopharmaceuticals?
   • Protein Structure and Sequence: Variations or modifications in the amino acid sequence can create epitopes that are recognized as foreign by the immune system.
   • Post-Translational Modifications: Changes such as glycosylation or pegylation can affect how the immune system perceives a protein.
   • Impurities and Contaminants: Trace elements from the production process, like host cell proteins, can enhance immunogenic potential.
   • Route of Administration: Intravenous, subcutaneous, or intramuscular delivery can influence the immunogenic response.
   • Dosage and Treatment Regimen: Frequency and amount of dosage can impact the intensity and type of immune response.
4. How does immunogenicity impact the pharmacokinetics and pharmacodynamics of drugs?
   • Altered Pharmacokinetics: The presence of anti-drug antibodies (ADAs) can lead to accelerated clearance of the drug from the bloodstream, reducing its half-life and overall effectiveness.
   • Reduced Pharmacodynamics: ADAs can neutralize the activity of the drug, diminishing its therapeutic effect and potentially leading to therapeutic failure.
   • Enhanced Clearance: In some cases, immune complexes formed between ADAs and the drug can enhance clearance mechanisms, affecting the drug's distribution and metabolism.
5. What advancements are being made in the field of immunogenicity analysis?
   • High-Throughput Screening: New technologies allow for the rapid screening of thousands of samples for ADAs, improving the efficiency of immunogenicity assessments.
   • Next-Generation Sequencing (NGS): NGS provides detailed insights into the immune repertoire that may react with the therapeutic, offering deeper understanding of immune response mechanisms.
   • Immunoinformatics: This field combines bioinformatics and immunology to predict immunogenic epitopes, enhancing the ability to design less immunogenic therapeutic proteins.
   • Integrated Multimodal Approaches: Combining multiple analytical techniques, including mass spectrometry and advanced imaging, to gain a more comprehensive understanding of immunogenic responses.

Resources

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All listed services and products are For Research Use Only. Do Not use in any diagnostic or therapeutic applications.