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Absorption Systems provides state-of-the-art preclinical formulation profiling and characterization of biologics. Our team is focused on streamlining the process and clinical development to expedite your biotherapy’s commercialization. |
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• Polypeptides |
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• False-negative results during proof of concept studies
• Altered PK or PD results
• Aggregation-induced activity losses and safety risks (e.g., immunogenicity)
• Reduced shelf life necessitating more frequent production
• Production losses from unstable process streams reducing product yield and increasing cost of goods
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Scientific expertise spanning two decades of biologic development and commercialization Comprehensive determination of conditions suitable for the formulation, production, storage, transport, and stability of biopharmaceuticals, including biosimilars, and vaccines. Consultative guidance for a variety of biologics including peptides, recombinant proteins, monoclonal antibodies, protein conjugates, nucleic acids, viruses, and virus-like particles. Excipient library containing over 150 entities including those generally-recognized as safe (GRAS), found in approved parenteral formulations, or known to stabilize biomolecules. Recommendations for establishing design space for critical quality attributes and critical process parameters. |
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Stability Enhancement Solubility Profiling |
Biophysical Characterization Biophysical and Analytical Technologies |