Biopharmaceutical Development and Production Week: Jeff Baker, FDA

| September 27, 2017

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In this interview, conducted at the 2014 Biopharmaceutical Development and Production Week, Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, U.S. FDA talks about the challenges in the bio processing industry.

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Defense biotech research looks to eliminate bacteria causing traveler’s diarrhea, reduce jet lag duration

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World traveler‘s will rejoice at the idea of a seemingly magical device that would guarantee they never suffer from the all-too-familiar stomach issues that come from traveling internationally while reducing jet lag at the same time. But it’s not just privileged globetrotters that would benefit from a device that eliminates the bacteria associated with the so-called Montezuma’s Revenge. In 2016, more than 230,000 children around the world died from some of the same types of bacteria as those that cause traveler’s diarrhea, and the bacteria mainly come from unsafe “drinking water, poor sanitation and malnutrition,” according to Oxford University’s Our World In Data portal. On Monday, DARPA announced it was researching an “implantable or ingestible bioelectronic carrier” that would eliminate the five major bacteria associated with traveler’s diarrhea.

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Translating Pharmacomicrobiomics: Three Actionable Challenges/Prospects in 2020

Article | February 24, 2020

The year 2020 marks a decade since the term pharmacomicrobiomics was coined (Rizkallah et al., 2010) to crystallize a century-old concept of mutual interactions between humans, drugs, and the microbial world. The human microbiome, with its immense metabolic potential that exceeds and expands the human metabolic capacities, has the ability to modulate pharmacotherapy by affecting both pharmacokinetics and pharmacodynamics of drug molecules:

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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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Learning How FoxA2 Helps Turn Stem Cells into Organs

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.

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