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...
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...
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
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...
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...
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...
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...
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...
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...
Offering Fact Sheet
Summary: Catalent Biologics' two state-of-the-art facilities have been designed to provide integrated bulk drug substance for clinical trials and commercial launches.