Upstream bioprocessing at large and commercial scales is projected to be the fastest growing segment of the single-use equipment market as products now in development using single-use systems (SUS) move up to commercial manufacturing. In addition, as cellular and gene therapies emerge, we will likely see SUS technologies created and adapted explicitly for these personalized applications.
In Q22018, ISR surveyed 100 sponsors who outsource bioprocessing to learn what drives CMO satisfaction. Quality compliance (27 percent) received the most mentions and narrowly edged out technical capabilities and technical service (23 percent) for the leading satisfaction driver. To learn more, follow the link to the Bioprocessing Market Trends and Outsourcing Dynamics report preview.
Dealing with contract development and manufacturing organizations (CDMOs) can be a daunting task for some drug developers. Here are five key factors to keep in mind when trying to troubleshoot drug development delays by selecting the right CMO.
By Joseph Pate, Benjamin Kester, Claudia Berdugo, Yunsong Li, and Victor Vinci,Catalent
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 in a biopharmaceutical downstream process. This study involved a design of experiment (DoE)-based approach to investigate the effects of pH and conductivity on the turbidity, yield, and impurity clearance of the Emphaze AEX Hybrid Purifier and the efficiency of the subsequent protein capture step. Filtration using the Emphaze AEX Hybrid Purifier resulted in a greater host cell protein (HCP) reduction and lower turbidity than unfiltered pools.
During the past decade there have been innumerable comparisons between stainless steel and single-use (SU) biomanufacturing systems. Issues such as capacity, scale-up, and flexibility dominate these discussions, and for good reason, considering each has a specific effect on the cost a sponsor will incur. Other topics evaluated as part of this comparison include energy usage, cleaning validation, cross-contamination risks, and the disposal of plastic waste.
Oncolytic viruses constitute a new promising therapeutic approach for the treatment of cancer. Here’s an example of a scalable, end-to-end process for oncolytic adenovirus production using modern tools and technologies.
In Q42017, ISR surveyed 153 sponsors who outsource biologic drug product manufacturing to gain insight into customer loyalty. CMO loyalty is computed as an index that consists of overall satisfaction, willingness to recommend, and the likelihood of using the contract manufacturer again.