Article
Quantification and Characterization of Polysorbate-80 in Protein Formulations
Summary: In this article, Luke Deters, Director of Biologics, discusses an appropriate method for quantification and characterization of polysorbate-80 (PS-80), a commonly-used, but highly-heterogenous, surfactant...
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White Papers
Regulatory Support
Summary: Our regulatory team completes over 150 agency submissions each year, supporting all stages of the product lifecycle. We assign a dedicated regulatory professional to each of our clients...
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Video
OneBio Suite: Integrated Biologics Development, Manufacturing and Supply
Summary: OneBio™ Suite provides integrated biologics development, manufacturing and supply with a single solution from cell line development through clinical supply. OneBio Suite is designed...
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Poster
A Brief Evaluation of the Impact of Thermal, Shear, and Light Stress on Adalimumab
Summary: The propensity of a protein to degrade under stress can vary widely among proteins and is important to understand in pharmaceutical development. A model protein, adalimumab, was tested by a limited...
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Poster
Multidimensional Evaluation of mAb Degraded Under Light, Shear and Thermal Stress Conditions
Summary: This poster evaluates the degradation of a therapeutic mAb, Adalimumab, resulting from light, shear and thermal stress. Degradation was evaluated using a combination of Sedimentation...
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Poster
High-Throughput Preformulation Development Platform for Biologics
Summary: Typically, in early development, the quantity of protein available for studies is limited, and a dataset is required to expedite Tox- and IND-enabling stability studies. In this study, a high-throughput formulation development...
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White Papers
Poster: Rapid Global Characterization of Immunoglobulin G1 Following Oxidative Stress
Summary: While peroxide and leachable metal-induced chemical modifications are among the most important quality attributes in bioprocess development, there is no mainstream characterization method covering all common...
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White Papers
Analytical Quality by Design Using Design of Experiments
Summary: At the center of analytical Quality by Design (QbD) is Design of Experiment (DoE). Using DoE, assay development begins with the creation of an analytical target profile to define method objectives including critical method...
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Webinars
From Basics To Best Practices: Exploring Bioassays And Binding Assays
Summary: Biologics analytical testing is rapidly evolving as new testing protocols become available and companies seek to expedite current methodologies. Learn about the latest cell-based...
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Brochure
Biologics Brochure
Summary: Explore our suite of proprietary technology platforms and range of integrated development, manufacturing and clinical supply services. Catalent Biologics partners with leading biologic and...
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