Antibody Characterization

Looking to unlock the full potential of your antibody? Whether it’s for your groundbreaking research project or to pave the way for innovative immunotherapies, antibody characterization is key. At ProteoGenix, we redefine the characterization of antibodies, offering an unmatched service that assesses 11 crucial antibody characteristics. We also provide flexible customized antibody characterization solutions for your most challenging projects. With over 3,000 monoclonal antibodies made, 30+ antibodies in clinical and pre-clinical trials, and 3 therapeutic antibodies on the market, we know how to rigorously profile your antibody. The best part? If we find an undesired antibody characteristic, we can fix it. Our one-stop integrated solutions can correct the most challenging antibody features, a service that is unmatched by our competitors. Let’s have a conversation about your antibody characterization needs today!

Why is antibody characterization important?

Investing in antibody characterization is not just a choice; it’s a necessity for progressing your research from the basic science stage to immunotherapy or diagnostic assay. At ProteoGenix, we empower you with the tools and expertise to unlock the full potential of your project.

The process of producing monoclonal antibodies results in a range of antibody modifications that take place at various antibody production stages. This results in a heterogenous monoclonal antibody preparation as the final product. These variations underscore the need for comprehensive characterization of antibodies to ensure the consistent and secure production of therapeutic antibodies.
Whether you’re attempting to engineer an immunotherapeutic or a biomedical research scientist, the success of your project often hinges on the specificity, reliability, and functionality of the antibodies you use. ProteoGenix’s antibody characterization service is important for the following reasons.

Precision in Research:

• Ensure that your experiments produce accurate and reproducible results.

• Eliminate cross-reactivity, saving time and resources. Increased Confidence in Data.

• Strengthen the validity of your findings with well-characterized antibodies.

• Enhance the trustworthiness of your research, diagnostic, or therapeutic antibody.

Optimized Assay Performance:

• Improve the sensitivity and specificity of diagnostic tests or assays.

• Maximize the therapeutic potential of antibodies in drug development such as Antibody Drug Conjugates (ADCs) or Bispecific antibodies.

Regulatory Compliance:

• Navigate regulatory requirements seamlessly with comprehensive characterization data.

• Expedite the approval processes for novel antibody diagnostic assays and therapeutics.

Antibody characterization techniques

At ProteoGenix, we employ a comprehensive suite of cutting-edge antibody characterization techniques to ensure the highest quality and reliability of our antibody products. From quantifying antibody titer using ELISA and assessing purity using SDS-PAGE to utilizing advanced techniques like Mass Spectrometry (MS) for in-depth characterization, we leave no stone unturned.

Our dedication to precise and thorough characterization of antibodies sets us apart, ensuring that you receive antibodies that meet the most stringent standards for your research, diagnostics, and therapeutic applications.

Our commitment to excellence also extends to an array of specialized techniques, including surface plasmon resonance (SPR) for precise affinity measurements of immobilized antigens or whole cells (SPRi), de novo Mass Spectrometry for detailed structural insights, and In silico post-translational modification analysis. We also utilize Differential Scanning Fluorimetry (DSF) and Dynamic Light Scattering (DLS) to assess stability and antibody size distribution (antibody aggregates) respectively. We also confirm purity at the molecular level using SEC-HPLC and ensure endotoxin levels are within safe levels using our Limulus Amebocyte Lysate (LAL) protocol.

ProteoGenix is your trusted partner for antibody characterization, providing you with the data and confidence you need for successful antibody development.

Antibody concentration vs. antibody titer

Understanding the distinction between antibody concentration and antibody titer is crucial for scientists as it ensures accurate dosing and consistent results in experiments and applications.

Concentration refers to the total antibody content, while titer specifically measures the active, functional antibodies, ensuring proper and effective use in research, diagnostics, or therapeutics.

At ProteoGenix, our commitment to excellence in antibody characterization shines through our cutting-edge methods. We measure antibody concentration using UV spectrophotometry and we measure the amount of functional antibody using ELISA titer assays. These methods provide the sensitivity and reliability needed to accurately identify your antibody’s concentration and titer.

Molecular weight determination

Determining the molecular weight of your custom monoclonal antibody is a pivotal step when developing your antibody for clinical use. It serves as a quality control measure to confirm the antibody’s correct composition and batch-to-batch consistency.

Molecular weight information aids in understanding post-translational modifications, and plays a role in pharmacokinetics, influencing dosing regimens. Regulatory compliance is streamlined with accurate data, while safety concerns are minimized. At ProteoGenix, we rigorously characterize the molecular weight of your antibody using two different approaches.

Using SDS-PAGE to determine antibody molecular weight

We begin analyzing the molecular weight of your antibody using SDS-PAGE. This is a robust and widely used method for analyzing antibody molecular weight. This technique allows our antibody experts to determine if your antibody preparations are consistent in size and charge. Next, we couple SDS-PAGE analysis with Mass Spectrometry.

Using mass spectrometry to identify antibody molecular weight

For a deeper and more detailed analysis of antibody molecular weight and antibody heterogeneity, we turn to Mass Spectrometry (MS). MS offers unparalleled accuracy in determining the molecular weight of antibodies. By ionizing and analyzing the mass-to-charge ratio of individual ions, we provide precise measurements, even detecting post-translational modifications and antibody variants. ProteoGenix employs MS to deliver comprehensive insights into your antibody’s molecular weight profile.

Antibody isotyping

Antibody isotyping is the process of identifying the specific class, such as IgG and IgM, and subclasses, such as IgG1, IgG2, IgG3, IgG4, and IgG5. Identifying your antibody class and subclass provides insights into functional properties and predicts performance characteristics in diagnostic and therapeutic applications. This knowledge helps researchers and scientists understand the antibody’s structure and function, and how it might interact with immune cells in vivo. This knowledge is critical when developing antibodies for immunotherapy or diagnostic applications.

At ProteoGenix, we offer comprehensive services that include two established antibody characterization techniques for antibody isotyping, PCR and ELISA.

How PCR is used to identify antibody isotype?

PCR is a versatile tool in antibody research, allowing us to amplify and identify the unique sequences that define the isotype and subtype of your antibodies. By harnessing the power of PCR, we can confirm the exact genetic makeup of your antibodies, providing you with the confidence that your research or therapeutic development is founded on accurate information. We next confirm the data generated from PCR using ELISA.

How ELISA is used to identify antibody isotype?

ProteoGenix rigorously characterizes the isotype of your monoclonal antibody not only by PCR but also by ELISA to further confirm your antibody’s class and subclass. Together these assays provide reliable antibody isotype determination results.

Utilizing PCR in conjunction with ELISA for isotype identification offers a comprehensive and precise approach, enhancing the accuracy and reliability of your monoclonal antibody characterization.

Antibody affinity measurement

Antibody Binding Affinity Measurement Services identifies the affinity of your antibody to its target antigen providing an abundance of information about your antibody. This is especially important when considering the development of your antibody for research, diagnostic, and therapeutic purposes. Here’s why it’s crucial:

• Efficacy in Target Binding

High-affinity interaction with the target antigen indicates strong and precise binding, which is essential to antibody performance. For instance, a therapeutic antibody with high affinity can selectively and efficiently neutralize or modulate the target, maximizing its therapeutic potential.

• Dose Optimization

Knowing the affinity allows you to optimize the therapeutic dosage. High-affinity antibodies can achieve therapeutic effects at lower concentrations, reducing the required dosage. This not only enhances patient safety but also lowers production costs and minimizes potential side effects associated with high doses.

• Duration of Action

Affinity influences the duration of the therapeutic effect. High-affinity antibodies tend to have a longer duration of action because they remain bound to the target for extended periods. This prolonged action can be advantageous for chronic conditions, reducing the frequency of administration.

• Minimizing Off-Target Effects

High-affinity antibodies are more likely to bind specifically to the intended target, minimizing the risk of off-target interactions. This specificity is critical for avoiding unintended consequences and side effects in patients.

• Enhanced Selectivity

Affinity is a key factor in determining the selectivity of the therapeutic. A high-affinity antibody is more likely to discriminate between closely related antigens, reducing the risk of cross-reactivity with similar molecules that could compromise safety and efficacy.

• Therapeutic Range

Affinity helps define the therapeutic range, which is the concentration range at which the antibody is effective without causing toxicity. Understanding the affinity allows you to establish the appropriate therapeutic range to achieve the desired clinical outcomes.

• Competitive Advantage

In a competitive therapeutic landscape, an antibody with superior affinity may outperform others in terms of efficacy, offering a competitive advantage in the market.

• Regulatory Approval

Regulatory agencies often require comprehensive characterization of therapeutic antibodies, including affinity determination, as part of the approval process. Demonstrating high affinity and specificity is crucial for obtaining regulatory clearance.

Determining the affinity of your antibody to its target antigen is vital for clinical development. It’s a critical parameter that can make the difference between a successful therapeutic antibody and one that falls short of expectations. Accurate affinity data obtained from thorough characterization is the foundation for successful therapeutic development.

ProteoGenix offers a full suite of antibody services. Therefore, if your antibody’s affinity falls short of expectations ProteoGenix offers affinity maturation services designed to improve your antibody’s affinity to the target antigen.

Surface plasmon resonance for antibody affinity measurement

ProteoGenix employs state-of-the-art Biacore Surface Plasmon Resonance (SPR) technology to precisely and comprehensively assess the affinity of antibodies to their target antigens.

SPR is a cutting-edge, real-time, and label-free technique that allows us to directly measure the binding interactions between antibodies and antigens with exceptional sensitivity and accuracy.
The Biacore SPR technology not only provides quantitative affinity data but also offers insights into:

• Binding kinetics of the antibody-antigen interaction

• Thermodynamics of the antibody-antigen interaction

This information is necessary for understanding how effectively your antibody engages its target, guiding therapeutic development by optimizing dosing regimens.

SPR imaging (SPRi) for antibody affinity measurement with cells

ProteoGenix also has the ability for high throughput measurement of your antibody’s affinity to samples in suspension such as mammalian cells, bacterial cells, virus-like particles, etc. using our cutting-edge Biacore Surface Plasmon Resonance Imaging (SPRi) technology. Identifying how your monoclonal antibody interacts with target cells is a crucial step in the development of effective immunotherapies such as monoclonal antibodies, bispecific antibodies, and antibody-drug complexes (ADCs). Here’s what SPRi can reveal about your antibody:

• Real-Time Cell Binding Analysis: SPRi offers real-time, label-free monitoring of interactions between your antibody and target cells. This dynamic analysis enables us to capture the kinetics of binding as it happens. It’s not just about whether binding occurs; it’s about how quickly it occurs and how stable the interaction is.

• Mimicking Physiological Conditions: Immunotherapies need to function effectively in the complex and dynamic environment of the human body. By using SPRi, ProteoGenix can simulate these physiological conditions, including temperature and fluid flow, to assess how well your antibody binds to target cells under realistic circumstances. This data is crucial for predicting how your immunotherapy will perform in vivo.

• Affinity and Specificity: SPRi provides detailed information about the affinity (binding strength) and specificity (selectivity) of your antibody-cell interactions. This data helps you understand not only whether the antibody binds to the cells but also how tightly and specifically it binds. High affinity and specificity are critical for effective immunotherapies, ensuring that the antibody targets the right cells with precision.

• Screening and Optimization: SPRi is a versatile tool for screening multiple candidate antibodies to identify the most promising candidates for your immunotherapy. It allows for efficient comparison of binding kinetics and can guide the selection and optimization of antibodies with the highest therapeutic potential.

• Early Problem Detection: By using SPRi, any issues with antibody-cell interactions can be identified and addressed early in the development process. This proactive approach helps avoid potential roadblocks and costly setbacks later in the immunotherapy development pipeline.

• Data-Driven Decision Making: The data generated from SPRi experiments is quantitative and provides a solid foundation for informed decision-making in the development of your immunotherapy. It guides the selection of lead candidates, supports dose optimization, and ensures the efficacy of your therapeutic approach.

ProteoGenix’s use of Biacore SPRi technology to assess antibody interaction with target cells is a powerful and forward-looking approach that provides real-time, physiologically relevant insights into your immunotherapy development.

Antibody amino acid sequencing

ProteoGenix can determine your antibody’s amino acid sequence, a crucial step, especially when considering the development of your antibody into a therapeutic. Here’s why it’s vitally important:

• Precision and Identity Verification: Knowing the exact amino acid sequence provides the ultimate level of precision and identity verification for your antibody. It ensures that the antibody you intend to develop as a therapeutic matches your design and expectations. This is fundamental for quality control and consistency in production.

• Batch Consistency: When producing therapeutic antibodies in large batches, maintaining batch-to-batch consistency is paramount. Amino acid sequencing allows you to confirm that each batch precisely matches the desired sequence, minimizing variability and ensuring therapeutic uniformity.

• Manufacturing Optimization: Understanding the amino acid sequence is essential for optimizing the manufacturing process. It helps identify potential challenges related to expression, purification, and formulation. Optimization at this stage can lead to increased yield, reduced production costs, and improved scalability.

• Quality Assurance: Amino acid sequencing can uncover any unexpected modifications or mutations in the antibody sequence. It helps detect alterations that might occur during production or storage, ensuring that your therapeutic maintains its integrity and functionality.

• Structure-Function Relationship: The amino acid sequence provides insights into the structure of your antibody. Understanding how different regions of the sequence correspond to the antibody’s functional domains is crucial for designing and engineering antibodies with optimized therapeutic properties.

• Regulatory Compliance: Regulatory agencies often require comprehensive characterization of therapeutic antibodies, including amino acid sequencing, during the approval process. Accurate sequence data is essential for regulatory compliance and expedites the approval of your therapeutic.

Determining the amino acid sequence of your antibody ensures precision, consistency, quality, and regulatory compliance throughout the development process. Accurate sequence data serves as the cornerstone for designing, producing, and optimizing a therapeutic antibody that meets the highest standards of safety and efficacy.

Using de novo mass spectroscopy to identify your antibody amino acid sequence

ProteoGenix uses de novo mass spectroscopy to identify the amino acid sequence of each antibody without prior knowledge of the sequence. This method accurately sequences antibodies, ensuring the highest level of precision and reliability in the characterization process. Here’s how it works:

• Sample Analysis

First, the antibody sample is analyzed using mass spectrometry, a technique that measures the mass-to-charge ratio of molecules.

• Peptide Mapping

The mass spectrometer generates fragmentation data for the antibody, breaking it into smaller peptide fragments. These fragments are then analyzed to determine their amino acid sequences.

• Sequencing

By reconstructing the sequences of individual peptides and aligning them, ProteoGenix can piece together the complete amino acid sequence of the antibody. This approach is particularly valuable when working with antibodies of unknown sequences or when confirming sequences in a non-standard context.

Antibody sequencing from hybridoma cell lines

In some cases, the antibody’s amino acid sequence may be known or partially known, especially if it was produced from a hybridoma cell line. ProteoGenix leverages this knowledge by starting the sequencing process with the available information from the hybridoma cell line:

• Sequence Confirmation

ProteoGenix uses the known or partial sequence from the hybridoma as a starting point. This information serves as a reference to confirm and validate the antibody’s sequence.

• Sequence Extension

Building upon the known segments, ProteoGenix extends the sequencing effort to complete the full amino acid sequence of the antibody. This approach ensures that the antibody’s sequence is fully characterized and accurate.

sequence of the antibody. This approach ensures that the antibody’s sequence is fully characterized and accurate.
By combining these two approaches—de novo mass spectrometry for unbiased sequencing and starting from hybridoma for confirmation—ProteoGenix guarantees a comprehensive and accurate determination of the antibody’s amino acid sequence. This level of precision is essential for the development of high-quality antibodies, whether for research, diagnostics, or therapeutic applications.

Post-translational modifications mapping

Unwanted post-translational modifications (PTMs) in antibodies can significantly impact their stability, efficacy, and safety. These modifications, which may include glycosylation, phosphorylation, or deamidation, can alter the antibody’s structure, charge, or binding affinity, leading to reduced efficacy, increased immunogenicity, and potential adverse reactions in patients. Thorough PTM analysis is crucial to identify and address these modifications, ensuring the development of safe and effective therapeutic antibodies.

Post-translational modification (PTM) mapping of an antibody is indispensable especially when considering the development of your antibody into a therapeutic. Here’s why it’s not just important and why you should consider PTM mapping as a top priority:

• Ensuring Safety and Efficacy: PTMs can significantly impact an antibody’s safety and efficacy. Mapping these modifications is crucial to ensure that your therapeutic antibody remains safe for patients and retains its intended function. It helps identify and mitigate potential risks associated with unintended PTMs that may affect the antibody’s behavior in the body.

• Optimizing Production: PTM mapping provides insights into the production process. It allows you to monitor and control PTMs that may occur during antibody production, minimizing batch-to-batch variability. This optimization ensures consistent quality and reduces the risk of costly production issues.

• Bioactivity Preservation: PTMs can influence an antibody’s bioactivity, affecting its binding affinity, specificity, and pharmacokinetics. Mapping PTMs helps you understand how these modifications impact the antibody’s behavior, enabling you to engineer or select antibodies with optimal bioactivity for therapeutic efficacy.

• Immunogenicity Mitigation: Some PTMs can trigger an immune response in patients, potentially leading to reduced therapeutic effectiveness or safety concerns. PTM mapping allows you to identify immunogenic PTMs and take steps to mitigate them, minimizing the risk of adverse reactions in patients.

• Stability Enhancement: Mapping PTMs aids in identifying modifications that may reduce the antibody’s stability or shelf life. Armed with this knowledge, you can optimize storage conditions and formulation to extend the therapeutic’s shelf life, ensuring it remains effective until the last dose.

• Precise Dosage: PTM mapping contributes to precise dosing regimens. By understanding how PTMs affect the antibody’s pharmacokinetics, you can optimize dosage strategies, ensuring that patients receive the right amount of the therapeutic for maximum benefit.

• Regulatory Compliance: Regulatory agencies require comprehensive characterization of therapeutic antibodies, including PTM mapping, as part of the approval process. Failing to provide this data can result in significant delays in obtaining regulatory clearance. By proactively conducting PTM mapping, you demonstrate your commitment to regulatory compliance and streamline the approval process.

• Competitive Advantage: In a competitive therapeutic landscape, meticulous PTM mapping sets your antibody apart. It demonstrates a commitment to quality, safety, and efficacy that can give your therapeutic a competitive edge in the market.

PTM mapping is not just important; it’s a fundamental pillar of therapeutic antibody development. It safeguards safety, efficacy, and regulatory compliance, optimizes production, preserves bioactivity, mitigates immunogenicity, enhances stability, and ensures precise dosing.

In silico PTM prediction and mass spectrometry to identify PTMs

ProteoGenix employs a comprehensive approach to map an antibody’s PTMs by combining in silico analysis with mass spectrometry. Here’s how this approach works and why it’s highly effective:

1. In Silico Analysis for PTM Site Identification:
In silico analysis refers to computer-based simulations and algorithms used to predict and identify potential PTM sites on antibodies. ProteoGenix leverages the power of computational tools to identify regions where PTMs may occur.

• PTM Prediction

Advanced bioinformatics tools are used to predict PTM sites based on known PTM motifs and structural characteristics. This predictive analysis narrows down the regions of interest, highlighting potential sites for further investigation.

• PTM Diversity

In silico analysis considers a wide range of PTMs, including glycosylation, phosphorylation, acetylation, and more. This diversity ensures that a comprehensive spectrum of modifications is explored.

2. Mass Spectrometry (Mass Spec) Confirmation:
Once potential PTM sites are identified through in silico analysis, ProteoGenix uses mass spectrometry to confirm and precisely characterize the PTMs. Here’s how mass spec contributes to the PTM mapping process:

• Sample Analysis

The antibody sample is subjected to mass spectrometry, a technique that measures the mass-to-charge ratio of molecules in the sample.

• PTM Detection

TMass spectrometry identifies and quantifies the specific PTMs present on the antibody. It provides detailed information about the type of PTM, the site of modification, and the extent of modification.

• Data Verification

Mass spectrometry data is compared with the predictions from in silico analysis. This verification step ensures the accuracy and reliability of the PTM mapping results.

Why This Approach is Effective:

Comprehensive Analysis: Combining in silico analysis with mass spectrometry offers a comprehensive approach to PTM mapping. It maximizes the chances of detecting various PTMs and provides a detailed understanding of their locations.

Efficiency: In silico analysis allows for efficient initial PTM site identification, narrowing down the search space. This efficiency saves time and resources in the subsequent mass spectrometry experiments.

Precision: Mass spectrometry is a high-precision technique that confirms the presence, location, and extent of PTMs. It provides quantitative data, ensuring accurate PTM mapping.

Validation: The synergy between in silico analysis and mass spectrometry allows for rigorous validation of PTM data, enhancing the reliability of the results.

ProteoGenix’s use of this combined approach ensures that PTMs on antibodies are not only identified but also accurately characterized. This is essential for understanding how PTMs impact antibody function, safety, and efficacy, making it a critical step in therapeutic antibody development and characterization.

Antibody Stability determination

Ensuring that your antibody remains intact and functional under various conditions is paramount for its efficacy and safety. At ProteoGenix, we understand the significance of stability determination in antibody characterization, and we employ cutting-edge Differential Scanning Fluorimetry (DSF) to achieve this goal.

Why Stability Matters:

• Therapeutic Efficacyhe stability of an antibody directly impacts its ability to deliver therapeutic benefits. Unstable antibodies may lose their activity, rendering treatments ineffective. Reliable stability data is crucial to guarantee consistent therapeutic outcomes.

• Patient Safety: An unstable antibody can lead to unexpected side effects, jeopardizing patient well-being. Rigorous stability assessment minimizes risks and enhances patient safety.

• Regulatory Approval: Regulatory agencies demand comprehensive stability data as part of the approval process. Accurate stability determination demonstrates your commitment to quality and compliance, streamlining regulatory clearance.

Why Choose ProteoGenix’s DSF:

Cutting-Edge Technology: ProteoGenix utilizes state-of-the-art Differential Scanning Fluorimetry (DSF) to assess antibody stability. DSF offers real-time, high-precision thermal stability analysis, allowing us to pinpoint stability issues with precision.

Comprehensive Insights: DSF not only identifies stability problems but also provides insights into the conditions that trigger instability. This information guides formulation strategies and storage recommendations, ensuring your antibody remains robust throughout its lifecycle.

Faster Development: With DSF, we expedite the development process by identifying stability challenges early. This proactive approach minimizes costly setbacks, accelerates development timelines, and markets your therapeutic antibody faster.

Quality Assurance: DSF data is the gold standard for quality assurance. It confirms that each batch of antibodies meets stringent stability criteria, providing batch-to-batch consistency that instills confidence in healthcare providers and patients.

Don’t leave the stability of your therapeutic antibody to chance. Partner with ProteoGenix to harness the power of DSF for robust stability determination.

Shelf life stability

Whether you’re developing therapeutic antibodies, diagnostic tools, or research reagents, the longevity of your antibodies matters. Understanding their shelf-life stability is pivotal for maintaining their efficacy and reliability over time.

Why Shelf-Life Stability Matters:

• Consistency in Results: In research and diagnostics, consistent results are non-negotiable. An antibody that degrades over time can lead to unreliable data, potentially compromising your research outcomes or diagnostic accuracy.

• Diagnostic Reliability: For diagnostic antibodies, the reliability of results directly affects patient care. A stable antibody ensures that diagnostic tests provide accurate and dependable information for healthcare decisions.

• Therapeutic Effectiveness: In the world of therapeutics, the shelf life of an antibody can impact patient treatment. Patients rely on the continued efficacy of antibodies, and stability assessment is essential for ensuring consistent therapeutic benefits.

• Regulatory Compliance: Regulatory authorities require comprehensive stability data as part of approvals for therapeutics and diagnostics. Accurate shelf-life stability assessment demonstrates your commitment to quality and compliance, facilitating regulatory clearance.

Colloidal stability

When it comes to developing antibodies for therapeutics, diagnostics, or research, colloidal stability is a factor that cannot be overlooked. Understanding and evaluating colloidal stability is key to ensuring that your antibody remains effective and reliable over time. At ProteoGenix, we recognize the pivotal role of colloidal stability assessment in antibody characterization for a multitude of applications.

Why Colloidal Stability Matters:

• Solution Integrity: Colloidal stability pertains to the stability of antibodies in solution. An unstable antibody can lead to aggregation, precipitation, or other undesirable changes that compromise the antibody’s integrity and effectiveness.

• Accurate Results: In research and diagnostics, accurate and reproducible results are paramount. Colloidal stability assessment helps maintain the antibody’s structural integrity, ensuring that it consistently delivers precise data and reliable outcomes.

• Diagnostic Reliability: Diagnostic assays depend on the stability of antibodies. Colloidal stability assessment is crucial to guarantee that diagnostic tests provide accurate and dependable information for healthcare decisions.

• Therapeutic Efficacy: In the realm of therapeutics, colloidal stability directly affects the effectiveness of antibody-based treatments. Patients rely on the continued stability of antibodies to receive consistent therapeutic benefits.

• Regulatory Compliance: Regulatory authorities mandate comprehensive stability data as part of approvals for therapeutics and diagnostics. Rigorous colloidal stability assessment showcases your commitment to quality and compliance, expediting regulatory clearance.

Don’t leave the stability of your antibodies to chance. Partner with ProteoGenix to assess colloidal stability and ensure that your antibodies remain potent, reliable, and effective in therapeutics, diagnostics, or research. Contact us today to initiate a journey toward robust antibody characterization. Your success begins here.

Aggregation

When crafting antibodies for immunotherapies or diagnostic applications, understanding their propensity to aggregate is paramount. Aggregation can compromise an antibody’s safety, efficacy, and reliability. At ProteoGenix, we emphasize the critical role of aggregate determination in antibody characterization for those in research striving to develop immunotherapies or diagnostic antibodies.

Why Aggregate Determination Matters:

• Safety Assurance: Aggregates in antibodies can pose safety concerns, triggering immune responses and adverse reactions in patients. Assessing aggregation helps ensure the safety of therapeutic or diagnostic antibodies.

• Efficacy Enhancement: Aggregates can reduce an antibody’s effectiveness by hindering binding to its target. Identifying and mitigating aggregates enhances the antibody’s potency and efficacy.

• Consistent Quality: Consistency is key in antibody production. Assessing aggregates guarantees batch-to-batch uniformity, essential for reliable results in research or consistent patient outcomes in therapies.

• Regulatory Compliance: Regulatory authorities demand comprehensive aggregate data during approvals. Thorough aggregate determination demonstrates your commitment to quality and compliance, streamlining regulatory clearance.

Why Choose ProteoGenix’s SEC-HPLC:

Cutting-Edge Technology: ProteoGenix employs Size-Exclusion Chromatography with High-Performance Liquid Chromatography (SEC-HPLC), a leading technique for aggregate identification. SEC-HPLC separates antibody species by size, allowing for precise analysis of aggregates.

In-Depth Analysis: Our SEC-HPLC techniques not only detect aggregates but also provide insights into their size, composition, and potential causes. This knowledge guides optimization and quality control strategies.

Customized Solutions: We recognize that different applications have unique requirements. Our tailored aggregate determination solutions address your specific needs, whether you’re developing immunotherapies or diagnostic antibodies.

Quality Assurance: With ProteoGenix, you can trust that your antibodies undergo rigorous aggregate evaluation. Our data-driven approach ensures that your products meet the highest quality standards.

Don’t leave the purity of your antibodies to chance. Partner with ProteoGenix to determine their propensity to aggregate and ensure they remain pure, potent, and reliable for your research, immunotherapies, or diagnostics.

Endotoxin level

When you’re on the path to crafting antibodies for immunotherapies or diagnostics, ensuring their purity is paramount. Measuring endotoxin levels in antibody suspensions is a vital step that cannot be overlooked. At ProteoGenix, we recognize the pivotal role of endotoxin measurement in antibody characterization for individuals in research pursuing immunotherapies or diagnostic antibodies.

Why Endotoxin Measurement Matters:

• Patient Safety: Endotoxins, often originating from bacterial sources, can pose serious health risks when present in therapeutic antibodies. Measuring endotoxin levels ensures the safety of patients receiving these treatments.

• Reliable Results: For diagnostic antibodies, the presence of endotoxins can interfere with test accuracy, leading to unreliable results. Accurate endotoxin measurement guarantees dependable diagnostic outcomes.

• Regulatory Compliance: Regulatory authorities require comprehensive endotoxin data as part of approvals for therapeutic antibodies and diagnostics. Rigorous endotoxin measurement showcases your commitment to quality and compliance, expediting regulatory clearance.

• Quality Assurance: Endotoxin levels can also serve as a marker for overall product quality. Maintaining low endotoxin levels is a testament to the purity and integrity of your antibody preparations.

Why Choose ProteoGenix’s LAL Kit:

Gold-Standard Technology: ProteoGenix utilizes the Limulus Amebocyte Lysate (LAL) kit, the gold standard for endotoxin measurement. LAL is highly sensitive and specific to endotoxins, offering reliable and precise results.

Comprehensive Analysis: Our LAL kit not only detects the presence of endotoxins but also quantifies their levels, allowing for a thorough assessment of endotoxin contamination in your antibody preps.

Customized Solutions: We understand that different applications have unique requirements. Our tailored endotoxin measurement solutions address your specific needs, whether you’re developing immunotherapies or diagnostic antibodies.

Quality Assurance: With ProteoGenix, you can have confidence that your antibodies undergo rigorous endotoxin evaluation. Our data-driven approach ensures that your products meet the highest quality standards.

Don’t compromise on the purity of your antibodies. Partner with ProteoGenix to measure endotoxin levels and ensure that your antibodies remain pure, safe, and reliable for your research, immunotherapies, or diagnostics.

Antibody DNA Sequencing

Critical to the development of monoclonal antibodies is the accurate sequencing of antibody DNA. This process is not merely a formality but an essential step that underpins the quality, consistency, and safety of each antibody. Here is why antibody sequencing is important:

• Sequence Verification

It ensures that the antibody’s DNA sequence matches the intended design, preventing potential errors in cloning or synthesis.

• Quality Control

It serves as a critical quality control step in antibody production, confirming that the correct genetic material has been used.

• Traceability

DNA sequencing provides a traceable record of the antibody’s genetic information, aiding in batch-to-batch consistency and regulatory compliance. You no longer have to worry about losing your fragile hybridoma cell lines.

• Identifying Mutations

Identify any unintended mutations or variations that may affect the antibody’s performance or safety.

• Intellectual Property Protection

DNA sequencing can be crucial for protecting intellectual property rights associated with the antibody’s genetic design.

Here is what you can expect when allowing ProteoGenix to identify the DNA sequence of your antibody.

The Antibody DNA Sequencing Process

ProteoGenix’s antibody DNA sequencing service process involves amplifying a DNA copy of the mRNA sequences (cDNA) and inserting it into an expression vector.

Our Antibody Sequencing Process:

1. mRNA extraction

2. Reverse transcription

3. DNA sequencing of at least 5 samples for sequence alignment

4. Sub-cloning into a standard vector

5. PCR amplification

6. Data analysis and detailed report generation

ProteoGenix offers a fully customizable antibody sequencing service with a strong track record of 16 years. Our standardized and exhaustive services ensure optimal performance, including sequencing antibody variable domains (VH, VL) and full-length antibodies (VH, VL, Fc).
Optional services like gene synthesis with codon optimization for specific expression systems (yeast, insect, mammalian) and recombinant antibody production.

Deliverables include a comprehensive report with annotated complementarity determining regions (CDR) sequences, an optional plasmid containing the sequence, and up to 2mg of recombinant antibody upon request