Article
Embarking Upon the Commercial Manufacturing Journey For a Biologic: Strategies to Achieve Successful Approval & Launch
Summary: There are several key considerations to how sponsor companies should approach commercial-scale manufacturing that may aid the success of their product’s commercial launch. In some cases, there is a need to identify...
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Case Study
A Strategy to Standardize Process Characterization & Late Phase Development – Cell Culture Optimization
Summary: Process characterization is an important step in the overall journey of product development. For therapies that have had early success in the clinic and are progressing toward commercial
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Webinars
How to Choose the Best Partner for Biologics Development and Manufacturing
Summary: Biologic development is complex, requiring a significant amount of time and resources to ensure the best chance of success. Consequently, there are numerous aspects...
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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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White Papers
Development Of An Intensified Fed-Batch Process Utilizing N-1 Perfusion And Ambr®15
Summary: While traditional fed-batch bioreactor process development has been well defined using methods such as shake flasks and bench-scale bioreactors, there is a desire to intensify...
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eBook
Complex Protein Production
Summary: Download the eBook to learn about innovative products and techniques for scale-up of complex biologics, get optimal cell culture medium and feed to maximize...
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Case Study
Evaluation of the 3M™ Emphaze™ AEX Hybrid Purifier
Summary: The 3M™ Emphaze™ AEX Hybrid Purifier is a novel purification tool that utilizes a Q-functional hydrogel and 0.2 μm membrane to reduce impurities...
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Article
A Strategy to Remove Formulation Development from the Critical Path
Summary: During this Q&A, Dr. Jun Lu, Director, Analytical Development at Catalent discusses how Catalent utilizes automation, specifically the UNcle® platform*, during formulation development...
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eBook
Trends in Biologics Manufacturing from Drug Substance to Fill/Finish
Summary: The biologics industry is growing rapidly with an estimated 40% of biopharmaceuticals in the industry pipeline. Consequently, pharmaceutical companies are strategically...
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Article
Systematic LC/MS/MS Investigations for the IND-Enabling Extended Characterization of Antibody–Drug Conjugate Modifications
Summary: ADCs are an important class of biologic drugs that are well-represented in clinical trials for oncology and other indications. These medicines harbor both...
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