FDA Pharmaceutical Quality Oversight

The launch of the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) is a milestone in FDA’s efforts to assure that quality medicines are available to the American public. As a new super-office within CDER, OPQ is strategically organized to streamline regulatory processes, advance regulatory standards, align areas of expertise, and originate surveillance of drug quality. Supporting these objectives will be an innovative and systematic approach to product quality knowledge management and informatics.

Spotlight

BRDG Park

The Bio Research & Development Growth (BRDG) Park at the Danforth Plant Science Center offers leading bio-research facilities with world-class wet labs, office space for lease and on-site workforce training. Emerging scientific enterprises get just the right combination for success – interactions between top scientists and access to state-of-the-art core facilities such as technologically advanced greenhouses, growth chambers, microscopy, proteomics and tissue transformation facilities, as well as other vital resources.

OTHER WHITEPAPERS
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IoT To The Rescue For Biotech & Pharma Manufacturing

whitePaper | April 7, 2020

The Internet of Things (IoT) could not be timelier for biotech/pharma. With fierce cost pressures, the push for value-based outcomes, and the need for flexible manufacturing solutions, the IoT is the much-needed shot in the arm to bring about transformational change. Sensors, actuators, and devices (“things”) embedded in production equipment and networked through computer systems can generate an enormous amount of data. The data can be mined for insights and opportunities to drive production efficiency, automate monitoring and controlling functions, and enable flexible manufacturing systems.

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The biopharmaceutical industry is leading the way in developing vaccines and treatments for COVID-19

whitePaper | April 8, 2020

The rapid spread of the novel coronavirus across the globe is a major public health threat for all, with profound health, social and economic impacts around the world. As a science-driven industry that aims to address some of the world’s biggest healthcare challenges, the research-based biopharmaceutical industry is uniquely positioned to respond rapidly to COVID-19. It has deep scientific knowledge gained from decades of experience working on developing solutions for combatting a range of infectious diseases such as MERS, SARS, Ebola and influenza.

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Pioneering Cell and Gene Therapy Solutions From Discovery to the Clinic

whitePaper | April 14, 2020

Your vision is to create revolutionary cell and gene therapies to treat life threatening diseases. Bio-Techne and its family of brands is on this journey with you. As a full-solution ancillary reagent and services provider, we will stand by you, providing flexible and pioneering tools to simplify your workflow. From CAR T cells to pluripotent stem cells, let us help you get your therapy to the patients that need it

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A digital ecosystem for Clinical Trails

whitePaper | July 30, 2021

Clinical trials are complex, lengthy, and resource-inefficient. The clinical research industry is responsible for the delivery of medical solutions to society by systematically evaluating their safety and efficacy in humans during so-called clinical trials. As exemplified by the COVID-19 pandemic, a steady and efficient influx of vaccines, therapeutics, and other innovative medical solutions is critical for meeting society’s current and future medical needs. Unfortunately, the industry faces several persistent issues that make clinical trial operations overly complex, lengthy, and resource-inefficient.

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Automated Extraction of High Molecular Weight DNA

whitePaper | November 14, 2019

SmartExtraction significantly simplifies the entire automated workflow of DNA extraction, setting new standards with regard to efficiency, yield and quality of the DNA.

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Next Generation Therapies and related Life Sciences topics

whitePaper | January 16, 2022

All gene therapies insert engineered DNA/RNA into living cells to make or modify new proteins

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Spotlight

BRDG Park

The Bio Research & Development Growth (BRDG) Park at the Danforth Plant Science Center offers leading bio-research facilities with world-class wet labs, office space for lease and on-site workforce training. Emerging scientific enterprises get just the right combination for success – interactions between top scientists and access to state-of-the-art core facilities such as technologically advanced greenhouses, growth chambers, microscopy, proteomics and tissue transformation facilities, as well as other vital resources.

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