service
Biophysical Characterization
Biophysical Characterization
Biophysical characterization helps you save time and improve quality of candidates at each stage
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.
Fast track your antibody discovery with our biophysical characterization workflows
get to know
Our Biophysical Characterization Workflows
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.
Early developability assessment, faster and better development process
Our methods are optimized for low material consumption, rendering them compatible with high-throughput production
Our focus is on key properties such as size, charge, polydispersity, non-specific interactions, viscosity, solubility and hydrophobicity
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.
Build the landscape and get to know your candidates
Our workflows are fully tailored to the target-product profile and customized to each development stage and antibody format.
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.
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.
OECD GLP standards guarantees that the biophysical characterization processes are meticulously documented, standing out for their swift submission to regulatory authorities.
Our seasoned characterization team can help develop reports for your regulatory authorities submission, reducing timelines and generating comprehensive documentation to support your IND filings.