21st Century Cures Act and revitalizing the biopharma industry

| December 14, 2016

article image
The nearly unanimous enactment of the 21st Century Cures Act by both the House and Senate potentially heralds a new era of global Healthcare leadership by the Unites States. America’s pharmaceutical and biotech sectors have been stagnant throughout the past presidential administration This is partly because of structural impediments to streamline drug approval and in part because the drugs, devices, and biologics required for the next century simply cannot be approved with the procedures that served us in the last century.

Spotlight

Neogen Europe Ltd.

Neogen Europe Ltd, the European subsidiary of Neogen Corporation, is a high technology business dedicated to the development and marketing of novel diagnostic kits. These kits focus on topical concerns about the quality and safety of food and agricultural products, from the quality of seed that goes into the ground, right through the chain to the safety of fully processed food products.

OTHER ARTICLES
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.

Read More
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.

Read More

Spotlight

Neogen Europe Ltd.

Neogen Europe Ltd, the European subsidiary of Neogen Corporation, is a high technology business dedicated to the development and marketing of novel diagnostic kits. These kits focus on topical concerns about the quality and safety of food and agricultural products, from the quality of seed that goes into the ground, right through the chain to the safety of fully processed food products.

Events