BIORESOURCE TECHNOLOGY

| September 29, 2019

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Bioresource Technology publishes original articles, review articles, case studies and short communications on the fundamentals, applications and management of bioresource technology.

Spotlight

Agendia, Inc.

Agendia is a leading molecular diagnostics company that develops and markets FFPE-based genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia’s tests were developed using an unbiased gene selection by analyzing the complete human genome. This includes MammaPrint as well as BluePrint, a molecular subtyping assay that provides deeper insight leading to more clinically actionable biology, TheraPrint, and TargetPrint, an ER/PR/HER2 expression assay. MammaPrint is the only breast cancer recurrence assay backed by peer-reviewed, prospective outcome data. These tests can help physicians assess a patient’s individual risk for metastasis, which patients may benefit from chemo, hormonal, or combination therapy, and which patients may not require these treatments and can instead be treated with other, less arduous and less costly methods.

OTHER ARTICLES

Pfizer, BioNTech Plan Clinical Trial for COVID-19 mRNA Vaccine Candidate

Article | April 9, 2020

Pfizer and BioNTech plan to begin human clinical trials on their lead COVID-19 therapeutic candidate, an mRNA vaccine, by the end of this month, the companies said today, through a collaboration that could generate up to $748 million for the German biotech. The companies announced plans last month to partner on BNT162, the first treatment to emerge from BioNTech’s accelerated COVID-19-focused development program, “Project Lightspeed.” BioNTech and Pfizer established collaboration intended to draw upon BioNTech’s proprietary mRNA vaccine platforms, and Pfizer’s expertise in vaccine research and development, regulatory capabilities, and global manufacturing and distribution network.

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Selexis Cell Line Development Strategies

Article | February 11, 2020

In today’s biotechnology landscape, to be competitive, meet regulations, and achieve market demands, “we must apply Bioprocessing 4.0,” said Igor Fisch, PhD, CEO, Selexis. In fact, in the last decade, “Selexis has evolved from cloning by limiting dilution to automated cell selection to nanofluidic chips and from monoclonality assessment by statistical calculation to proprietary bioinformatic analysis,” he added. Single-use processing systems are an expanding part of the biomanufacturing world; as such, they are a major component of Bioprocessing 4.0. “At Selexis, we use single use throughout our cell line development workflow. Currently, we have incorporated single-use automated bioprocessing systems such as ambr® and the Beacon® optofluidic platform for accelerated cell line development. By using these systems and optimizing our parameters, we were able to achieve high titers in shake flasks. Additionally, the Beacon systems integrate miniaturized cell culture with high-throughput liquid handling automation and cell imaging. This allows us to control, adjust, and monitor programs at the same time,” noted Fisch.

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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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Spotlight

Agendia, Inc.

Agendia is a leading molecular diagnostics company that develops and markets FFPE-based genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia’s tests were developed using an unbiased gene selection by analyzing the complete human genome. This includes MammaPrint as well as BluePrint, a molecular subtyping assay that provides deeper insight leading to more clinically actionable biology, TheraPrint, and TargetPrint, an ER/PR/HER2 expression assay. MammaPrint is the only breast cancer recurrence assay backed by peer-reviewed, prospective outcome data. These tests can help physicians assess a patient’s individual risk for metastasis, which patients may benefit from chemo, hormonal, or combination therapy, and which patients may not require these treatments and can instead be treated with other, less arduous and less costly methods.

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