Author: Dr Eric Miller, Sr. Director and Scientific Project Leader for Analytical
The biotech industry, characterized by its rapid pace and competitive nature, presents unique challenges, especially for smaller companies. Limited funding often hinders these companies’ ability to conduct extensive research and development. This scenario underscores the need for a solution that not only streamlines data acquisition but also ensures the quality and speed of data analysis. High-quality data, obtained expeditiously, is critical for these companies to reach patients or value inflection points, which in turn is essential for growth.
LabZient™: An Innovative Solution
In response to industry challenges, Abzena has developed the LabZient™ analytical platform, a pioneering tool designed to revolutionize the assessment and validation process of large molecules like antibodies and bioconjugates. The platform’s innovative approach hinges on standardizing and automating these processes, significantly cutting down on the time and resources traditionally required. By employing predictable and standardized methods, LabZient™ not only hastens the journey towards an Investigational New Drug (IND) application but also boosts overall efficiency and reduces risks. This is particularly advantageous for biotech companies aiming for rapid market entry, as it enables them to navigate the development process more swiftly and effectively.
Streamlining the Path to IND
LabZient™ distinguishes itself by using FDA-validated analytical methods, which harmoniously combine predictive in-silico evaluations with proven laboratory techniques. This dual approach is key in facilitating the testing of quality attributes in early-stage development of multiple antibody products. Traditional methods, often slower and less efficient, are outpaced by LabZient™, which provides crucial, high-quality data much faster. This not only accelerates the development timeline but also empowers companies to make informed decisions earlier, enhancing the likelihood of clinical and commercial success.
The Technology Behind LabZient™
At the core of LabZient™ is its ability to leverage structural similarities within the IgG1 and IgG4 immunoglobulin subclasses. Using in-silico analysis to determine physicochemical characteristics, the platform can predict how a target molecule will perform when tested with pre-validated methods. This means that antibodies showing high similarity to those used in validating the platform can be fast-tracked. Validation data from these standards are extrapolated to the antibody under test, thereby reducing the time and resources needed for development, qualification, and verification. This cost-effective, phase-appropriate pathway significantly accelerates the process of reaching clinical trial readiness.
Operational Efficiencies and Future Directions
The LabZient™ process commences with the transfer of existing product-specific analytical data for the antibody under test. An Analytical Target Profile (ATP) is developed, which is crucial in defining the product-specific Critical Quality Attributes (CQAs). An in-silico similarity assessment follows, comparing the structural and physicochemical properties of the antibody under test with those of previously validated IgG1/4 molecules. This assessment is vital for de-risking the development process and forming a comprehensive understanding of the method’s fitness for the intended purpose. Looking ahead, Abzena aims to expand LabZient™’s application to more complex molecules, such as antibody-drug conjugates (ADCs), addressing the evolving and diverse needs in the field of biotech analytics.
Abzena’s LabZient™ analytical platform is a landmark development in biotech analytics. It offers a more efficient and faster method for acquiring high-quality data, essential for biotech and pharmaceutical companies focused on making significant strides in a highly competitive environment. LabZient™ aids in overcoming the common hurdles faced by these companies and helps de-risk and pave the way for groundbreaking advancements in biotechnological research and development.
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