Catalent Biologics Content
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Process Development: Ensuring A Consistent, High-Quality Biologic
11/4/2020
It’s critical that biopharma companies work with a partner that has the proven expertise to conduct drug product process development on their innovator or biosimilar drugs.
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Rapid Global Characterization Of Ig G1 Following Oxidative Stress
11/22/2019
Review a method for rapid and consistent global characterization of leachable metals- or peroxide-stressed immunoglobulin (Ig) G1 monoclonal antibodies (mAbs).
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High-Throughput Preformulation Development Platform For Biologics
11/21/2019
A high-throughput formulation development for sample preparation and sample analysis enabled a simple and less labor-intensive screening of a broad range of conditions in considerably less time.
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Analytical Quality By Design Using Design Of Experiments
11/21/2019
Design of Experiment (DoE) is the centerpiece of analytical Quality by Design. A DoE assay development pipeline approach delivers optimized, robust, and rugged analytical methods ready for method qualification.
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Strategies To Achieve Successful Approval & Launch
11/18/2019
Four experts share how scale-up, regulatory expectations, demand forecasting, and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey.
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Standardizing Process Characterization And Late Phase Development
11/18/2019
Learn an approach for process characterization to produce a monoclonal antibody, specifically at the drug substance biomanufacturing step, to improve efficiency and effectiveness.
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Characterization Of A Therapeutic mAb, Associated Antigen-Binding Fragments
10/9/2019
Determining size homogeneity of a mAb in solution is important for comparability and characterization. For this study, an IgG1 antibody was cleaved into antigen-binding fragments using pepsin and papain digestion respectively, followed by Protein A purification.
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Intensified Fed-Batch Process Using N-1 Perfusion And ambr 15
10/9/2019
Learn how to combine N-1 perfusion with the ambr®15 bioreactor system to create a powerful tool for rapid development of a highly efficient cell culture process.
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A Strategy To Remove Formulation Development From The Critical Path During Biologics Development
6/10/2019
As the product development program progresses to phase 3 clinical stage, formulation development is required to ensure drug product quality and stability during manufacturing, storage, and clinical administration. This Q&A discusses the utilization of automation, specifically the Uncle platform, during formulation development.
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Solution To Ensure Quantity And Quality Of The Excipient Polysorbate-80 In Drug Formulations
6/10/2019
Excipients are valuable substances used to improve stability and potency, but their sourcing and stability can be a challenge. A two-method solution to evaluate one such excipient, PS-80, for quantity and quality has multiple applications for drug developers looking to utilize this in their final product.