Newsletter | June 26, 2019

06.26.19 -- Trends In Single-Use System Adoption In The Biopharma Industry

Featured Editorial
Trends In Single-Use System Adoption In The Biopharma Industry
By Ilene Roizman, BioPlan Associates, Inc.

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.

Top Five Satisfaction Drivers For Outsourced Bioprocessing

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.

Industry Insights
5 Keys To Avoid Drug Development Delays When Using CDMOs
Article | By Ken Chomistek, Singota Solutions

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.

Case Study For Evaluation Of The 3M Emphaze AEX Hybrid Purifier Involving Low Isoelectric Point Target Proteins
Poster | 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.

It Depends: The Real Answer To The Single-Use Or Stainless Steel Question
Article | Samsung BioLogics

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.

End-To-End Process For Oncolytic Adenovirus Production
Application Note | GE Healthcare Life Sciences

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.

Customer Loyalty In Biologic Drug Product Manufacturing
Infographic | ISR Reports

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.

Optimizing Your Plate-Based Assay Workflows
Webinar | Dassault Systemes Americas

Using workflow-based software solutions to guide scientists through various processes in low- to high-throughput screening campaigns.

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