Search results for " characterization"

Article Monitoring and Control of Inline Dilution Processes
Buffer management has received less attention in process intensification despite the high costs and labor-, space-, time-, and material-intensive nature of this common downstream activity. By…

Article Design Considerations for a Commercial Cell and Gene Therapy Facility
The commercialization of cell and gene therapies has become a reality, prompting deeper considerations of logistics, technology, and design for manufacturing facilities. By Feliza Mirasol …

Article Moving PAT from Concept to Reality
The learning curve for process analytical technology has slowed widespread adoption. By Cynthia A. Challener alexlmx a- Stock.Adobe.com Process analytical technology (P…

Article Emerging Therapies Test Existing Bioanalytical Methods
Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex thera…

Article Scalable Viral Vector Manufacturing
The interest for robust and scalable viral vector manufacturing is rapidly increasing, with the recent developments of both cell and gene therapy and oncolytic virus-based therapies. As cost pressur…

Article Scaling Up Novel Therapies
Scaling Up Novel Therapies Platform processes have improved monoclonal antibody scale-up. Can they do the same for personalized therapies? By Agnes S…

Article Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…

Article Modern Manufacturing Key to More Effective Vaccines
Modern Manufacturing Key to More Effective Vaccines Accelerated development of new preventives raises challenges for efficient CMC evaluation and production. By Jill Wechsler …

Article Transformative Medicines Challenge FDA and Manufacturers
Transformative Medicines Challenge FDA and Manufacturers New gene therapies and combination products require innovative regulatory approaches. By Jill Wechsler …

Article Development of Purification for Challenging Fc-Fusion Proteins
Development of Purification for Challenging Fc-Fusion Proteins This study outlines methods for an alternative protein-polishing process for challenging proteins. …

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