Therapeutic Developability Assessment Service
Background What We Can Offer Publication Highlights FAQs Customer Review Related Services Contact Us
To combat challenges like low approval rates and high costs, screening potential candidates in early drug discovery stages is crucial. Creative Biolabs specializes in therapeutic developability assessment to help clients reduce risks and shorten the overall research timeline.
De-Risking Your Biologics Pipeline with Strategic Developability Assessment
Developability assessment is a proactive strategy to evaluate a molecule's physicochemical and biological properties early in the discovery phase. The success of a therapeutic antibody or other biologic relies on its "developability"—the likelihood of it becoming a stable, manufacturable, and safe drug. At Creative Biolabs, they screen for consistent manufacturability, low product heterogeneity, and stability to ensure high yields and quality, ultimately reducing the cost and time of downstream manufacturing. This is an increasingly critical criterion for mitigating potential risks in drug discovery.
The Pillars of a Viable Therapeutic: A Multifaceted Approach
Developability assessment is a comprehensive, multi-faceted evaluation that goes beyond mere biological activity. It is an intricate process designed to determine a molecule's potential to be successfully developed, manufactured, and formulated into a safe and effective drug. We analyze a candidate across three critical pillars:
Physicochemical Properties
We meticulously evaluate properties like purity, fragmentation, aggregation, and solubility. We use techniques like size exclusion high-performance liquid chromatography (SEC-HPLC) and dynamic light scattering (DLS) to quantify aggregates. We also assess thermal stability with differential scanning calorimetry (DSC) and differential scanning fluorimetry (DSF).
Manufacturability Assessment
We focus on optimizing expression levels and yield to ensure reliable, high-quality output. We scrutinize the molecule for post-translational modifications (PTMs) and chemical degradation pathways and conduct forced degradation studies to inform downstream manufacturing.
In Vivo Fitness & Safety Profiling
We predict a drug's behavior in vivo by performing serum stability and half-life characterization studies. We also minimize immunogenicity risks by assessing undesirable off-target binding using FcRn and FcγR binding assays.
Publication
This publication presents a case study on the use of advanced kinetic modeling to predict the long-term stability of a therapeutic peptide. The researchers analyzed the peptide's chemical degradation under accelerated conditions to derive long-term stability predictions. These predictions, which provided stability insights within weeks, were a crucial factor in deciding to move the drug into clinical development. The predictions were later confirmed to be highly accurate when compared to analytical data measured under long-term conditions during the subsequent development phase. The authors note that, to their knowledge, such an in silico study on a therapeutic peptide with comparisons to real-life long-term stability data had not been previously described in the literature.
Fig.1 Advanced kinetic modeling for prediction of the long-term stability of a therapeutic peptide.1
Why Choose Us?
Our competitive advantage lies in our seamless integration of cutting-edge technology and a consultative, client-focused approach. Creative Biolabs combines powerful in silico predictive tools with a full suite of orthogonal biophysical assays, allowing us to screen your candidates faster and with greater confidence than traditional methods. If a high-risk issue is identified, our in-house protein engineering experts can immediately begin to optimize the molecule, preserving its efficacy while improving its developability. Our proven track record in therapeutic antibody development, combined with our ability to provide end-to-end solutions, makes Creative Biolabs the ideal partner to navigate the complexities of your biologics pipeline. We believe that by building developability into your molecule from the outset, we are not just providing a service, we are building a foundation for success.
Highlights:
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Reduce development costs and time.
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Accelerate the lead candidate optimization process.
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De-risk your pipeline before problems arise in the development process.
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Improve the chance of successful manufacturing scale-up.
Experience the Creative Biolabs Advantage - Get a Quote Today!
FAQs
Q1: What is the primary purpose of a therapeutic developability assessment?
A1: The main goal is to identify and address potential issues with a molecule's stability, manufacturability, and safety profile as early as possible in the drug development process. This helps you select the best candidate to move forward with, saving significant time and resources.
Q2: Can your services handle complex therapeutic modalities like bispecifics or ADCs?
A2: Yes, our platform is specifically designed to be flexible and comprehensive. We have a proven track record of assessing a wide range of complex therapeutic modalities. We encourage you to reach out to our team to discuss your specific project needs.
Q3: Do you offer solutions if a high-risk issue is identified during the assessment?
A3: Absolutely. Our integrated approach means that if we identify a developability risk, our team of protein engineering specialists can work with you to optimize the molecule's sequence, improving its properties while maintaining its biological function.
Customer Review
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Problem solved
Using Creative Biolabs' therapeutic developability assessment in our research has significantly improved our ability to prioritize candidates. The detailed analysis of potential post-translational modifications (PTMs) allowed us to make a data-driven decision, which led to an advance, saving us months of development time. It's a critical tool for our pipeline. - J*****n M
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Key Finding
We were facing high aggregation rates with one of our lead compounds. The DLS and SEC-MALS data from Creative Biolabs' service were a game-changer. We identified the precise conditions causing the instability and, with their guidance, were able to reformulate the protein successfully. The service is incredibly thorough and practical. - A*****a K
Related Services
Creative Biolabs offers a full suite of complementary services to support your therapeutic antibody development journey. These include:
Genotoxicity Assessment Services
Genotoxicity assessment, a cornerstone of in vitro safety pharmacology, evaluates a compound's potential to damage genetic material. Creative Biolabs' comprehensive services use a range of standard and cutting-edge assays to detect DNA and chromosomal damage, providing reliable, actionable insights for drug development and regulatory submissions.
Learn More →
Post-translational Modification
PTMs are covalent and enzymatic protein modifications that regulate cellular processes like metabolism and cell signaling. Creative Biolabs offers various PTM services to analyze modification categories and sites, which are essential for studying cell biology and disease.
Learn More →
Contact Us
Ready to de-risk your pipeline and accelerate your path to the clinic? Our expert team is ready to assist you. Contact us today for a detailed discussion about your project and to explore how our Therapeutic Developability Assessment platform can meet your specific needs.
Reference
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Evers, A., D. Clénet, and S. Pfeiffer-Marek. "Long-Term Stability Prediction for Developability Assessment of Biopharmaceutics Using Advanced Kinetic Modeling." Pharmaceutics 14.2 (2022). Distributed under Open Access license CC BY 4.0, without modification. DOI: https://doi.org/10.3390/pharmaceutics14020375
