Biotech industry focuses on CRISPR, new gene breeding techniques to break regulatory logjam

MARIA BROWN | January 5, 2017

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Commodity groups, farm organizations and others considered the summer’s GMO labeling law a prudent compromise for what had become a divisive issue. How the United States Department of Agriculture decides to lay out these new labeling rules over the next two years, particularly if they choose to focus on product rather than process, will cement the bill’s lasting impact.

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Roivant Sciences

Roivant Sciences is a global healthcare company focused on realizing the full value of promising biomedical research to improve the lives of patients and their families. Roivant’s mission is to reduce the time and cost of developing new medicines for patients and to share those savings with the broader healthcare system.

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MEDICAL

Better Purification and Recovery in Bioprocessing

Article | August 2, 2021

In the downstream portion of any bioprocess, one must pick through the dross before one can seize the gold the biotherapeutic that the bioprocess was always meant to generate. Unfortunately, the dross is both voluminous and various. And the biotherapeutic gold, unlike real gold, is corruptible. That is, it can suffer structural damage and activity loss. When discarding the dross and collecting the gold, bioprocessors must be efficient and gentle. They must, to the extent possible, eliminate contaminants and organic debris while ensuring that biotherapeutics avoid aggregation-inducing stresses and retain their integrity during purification and recovery. Anything less compromises purity and reduces yield. To purify and recover biotherapeutics efficiently and gently, bioprocessors must avail themselves of the most appropriate tools and techniques. Here, we talk with several experts about which tools and techniques can help bioprocessors overcome persistent challenges. Some of these experts also touch on new approaches that can help bioprocessors address emerging challenges.

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DIAGNOSTICS

Making Predictions by Digitizing Bioprocessing

Article | April 20, 2021

With advances in data analytics and machine learning, the move from descriptive and diagnostic analytics to predictive and prescriptive analytics and controls—allowing us to better forecast and understand what will happen and thus optimize process outcomes—is not only feasible but inevitable, according to Bonnie Shum, principal engineer, pharma technical innovation, technology & manufacturing sciences and technology at Genentech. “Well-trained artificial intelligence systems can help drive better decision making and how data is analyzed from drug discovery to process development and to manufacturing processes,” she says. Those advances, though, only really matter when they improve the lives of patients. That’s exactly what Shum expects. “The convergence of digital transformation and operational/processing changes will be critical for the facilities of the future and meeting the needs of our patients,” she continues. “Digital solutions may one day provide fully automated bioprocessing, eliminating manual intervention and enabling us to anticipate potential process deviations to prevent process failures, leading to real-time release and thus faster access for patients.” To turn Bioprocessing 4.0 into a production line for precision healthcare, real-time release and quickly manufacturing personalized medicines will be critical. Adding digitization and advanced analytics wherever possible will drive those improvements. In fact, many of these improvements, especially moving from descriptive to predictive bioprocessing, depend on more digitization.

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Spotlight

Roivant Sciences

Roivant Sciences is a global healthcare company focused on realizing the full value of promising biomedical research to improve the lives of patients and their families. Roivant’s mission is to reduce the time and cost of developing new medicines for patients and to share those savings with the broader healthcare system.

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