Article | March 18, 2020
Scientists at the Perelman School of Medicine at the University of Pennsylvania discovered early on in each cell, FoxA2 simultaneously binds to both the chromosomal proteins and the DNA, opening the flood gates for gene activation. The discovery, “Gene network transitions in embryos depend upon interactions between a pioneer transcription factor and core histones,” published in Nature Genetics, helps untangle mysteries of how embryonic stem cells develop into organs, according to the researchers. “Gene network transitions in embryos and other fate-changing contexts involve combinations of transcription factors. A subset of fate-changing transcription factors act as pioneers; they scan and target nucleosomal DNA and initiate cooperative events that can open the local chromatin. However, a gap has remained in understanding how molecular interactions with the nucleosome contribute to the chromatin-opening phenomenon,” write the investigators.
Article | February 24, 2020
The big question at the start of 2019 was whether the IPO window would stay open for biotech companies, particularly those seeking to pull off ever-larger IPOs at increasingly earlier stages of development. The short answer is yes—kind of. Here’s the long answer: In the words of Renaissance Capital, the IPO market had “a mostly good year.” The total number of deals fell to 159 from 192 the year before, but technology and healthcare companies were standout performers. The latter—which include biotech, medtech and diagnostics companies—led the pack, making up 43% of all IPOs in 2019. By Renaissance’s count, seven companies went public at valuations exceeding $1 billion, up from five the year before
Article | February 18, 2020
The Bioprocessing 4.0 concept seeks to apply automation and technology to the digital transformation of biologics manufacturing. As the paradigm moves forward, it faces barriers to its adoption, according to Eric Langer, president of BioPlan Associates. “Perhaps the greatest challenges involve unsecured links and adapting the applications to areas where automation is critically needed today,” says Langer. “Unresolved security issues could seriously affect a company’s data in a regulated environment, so they will need to have iron-clad anti-hacking protection in place. Unfortunately, cyber security is not yet a top focus for the industry.”
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.