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Biophysical Characterization

Advanced Biophysical Characterization | FairJourney Biologics

Biophysical characterization helps you save time and improve quality of candidates at each stage

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Biophysical characterization plays a vital role in therapeutic antibody developability by providing valuable insights into the physical and chemical properties of antibodies. Including biophysical characterization early on in discovery campaigns can reduce timelines in CMC and process development stages while increasing the chances of success.

We offer a comprehensive range of assays, catering from the early to the late stages of development, covering hundreds of clones down to a few candidates. All of which can be fully customized to your project needs: tailored to each research stage, both in terms of throughput and the properties explored.

Our labs are GLP certified and have assay development capabilities able to support late-stage characterization and report writing for regulatory filling.

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Fast track your antibody discovery with our biophysical characterization workflows

Early stage developability screenings

Late stage detailed lead characterization

Target Product Profile tailored workflows

GLP-certified

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Our Biophysical Characterization Workflows

Early Stage

Screen your antibody panel and select lead candidates with promising biophysical attributes. With a small protein amount, you will have a wide knowledge on the key properties of your candidates, helping you streamline the drug discovery process, reduce costs, and accelerate the identification of potential biopharmaceutical products.

Late Stage

Our late-stage biophysical characterization includes in-depth analysis of the selected lead biologic candidates. Through advanced techniques and state-of-the-art instrumentation, we assess critical attributes, providing essential insights to make informed decisions and ensuring product quality and suitability for manufacturing and patient use.

GLP

We uphold the OECD Principles of Good Laboratory Practice (GLP) to ensure the production of high-quality and dependable test data concerning the safety of industrial chemical substances and preparations. Through our adherence to the GLP System, we promote the efficient utilization of resources, optimizing both cost and time by avoiding redundant experimentation. By embracing these principles, we maintain a commitment to excellence, providing you with accurate and trustworthy data for informed decision-making and regulatory compliance.

Early stage

On our early stage biophysical characterization, only a small amount of protein is needed for a complete and comprehensive high throughput screening.

Our developability assays provide meaningful insights into key properties such as melting temperature, aggregation and hydrophobicity, signalling potential negative features that might become red flags later in development stages. This analysis can be paired with functional characterization, including kinetics, and cell-based assays, providing a comprehensive understanding of the antibody candidates' performance.

In just 2 weeks, we are able to perform a streamlined evaluation of early antibody developability and identify potential issues efficiently.

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Early developability assessment, faster and better development process

Low material consumption

Our methods are optimized for low material consumption, rendering them compatible with high-throughput production

Emphasis on key properties

Our focus is on key properties such as size, charge, polydispersity, non-specific interactions, viscosity, solubility and hydrophobicity

High throughput cutting-edge methods

Our labs are equipped with a vast array of state-of-the-art high throughput and high precision equipment.

Late stage

Comprehensive biophysical characterization is essential to ensure quality, safety, and efficacy of the final product at later stages of biopharmaceutical candidates research.Our team can help you fully characterize your candidates, understand pCQAs and define an efficient CMC strategy to fast track your antibody through development and into clinical stages.

Our expert scientists conduct detailed profiling of lead antibody candidates to assess the robustness and behaviour of the antibodies under stressing conditions. By focusing on the target product profile, we can design fully tailored workflows and generate data that provides valuable insights for process development and formulation optimization.In addition to our standardly available studies, we can develop and incorporate a wide range of tailored methods suited to your needs.

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Build the landscape and get to know your candidates

Custom workflows

Our workflows are fully tailored to the target-product profile and customized to each development stage and antibody format.

Detailed profiling of leads

Our accelerated stability studies and forced degradation supported by our mass spectroscopy facilities, as well as, our pre-formulation studies allow for a detailed understanding of antibody behaviour.

Bespoke methods

In addition to our standardly available studies, we can develop a while range of tailored methods suited to your needs.

GLP

Our Biophysical characterization labs and related activities are Good Laboratory Practice (GLP) certified, which is of paramount importance during late-stage biophysical characterization in the field of biopharmaceutical development. We comply with a set of stringent principles and quality measures to ensure reliability, traceability, accuracy, and integrity of experimental data.

GLP standards guarantees that the biophysical characterization processes are conducted consistently and in a formal, well-documented manner, recognized for fast regulatory authorities’ submission.

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Reliable and consistent data

OECD GLP standards guarantees that the biophysical characterization processes are meticulously documented, standing out for their swift submission to regulatory authorities.

Support with report writing

Our seasoned characterization team can help develop reports for your regulatory authorities submission, reducing timelines and generating comprehensive documentation to support your IND filings.

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