Biopharma

The Role of ADME & Toxicology Studies in Drug Discovery & Development

What do ADMET studies provide to drug developers? A critical piece in drug discovery and development is conducting DMPK (Drug Metabolism and Pharmacokinetics) studies, often referred to as ADMET (Absorption, Distribution, Metabolism, Elimination, Toxicity) studies. These studies help to determine the viability of a drug candidate by answering these key questions: Absorption – How much…

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Connecting the Microbial Ecosystem

The Microbiome – A Growing Field Within Research and Development An emerging field of research across multiple industries is the study of the microbiome. Understanding the components of the microbiome, such as bacteria, viruses, and fungi, impacts food production, animal health, environmental restoration and, perhaps most importantly, human health. We now understand that the human…

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WRIB 2018 – A Workshop on Recent Issues in Bioanalysis

A Collaborative Workshop to Discuss Bioanalysis The Workshop on Recent Issues in Bioanalysis (WRIB) gathers industry and regulatory leaders from around the world, to discuss challenges in the discovery and development of bioanalytical, biomarker, and immunogenicity assays. The FDA, Regeneron, Pfizer, MHRA, Sanofi, EMA, Bristol-Myers Squibb, and Biogen were just some of the presenters from this…

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Antibody Profiling

Assays to Predict Developability Antibody therapies are not novel. The first FDA approval and commercialization for an antibody therapeutic was in 1986 for Orthoclone OKT3, which was approved for prevention of kidney transplant rejection (Ecker et al. 2015). As of today, there are 78 monoclonal antibody treatments on the market to treat a wide variety…

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New Apps for Small Molecule Discovery

Increase Functionality from Design to Downstream Testing The Drug Discovery Solution for  Thermo Fisher™ Platform for Science™ software is expanding, with the release of three new applications to the Marketplace. This set of applications delivers new functionality which can be leveraged throughout small molecule discovery workflows. Users can now request the synthesis of compounds, verify…

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Informatics Challenges in Pharma and Biopharma R&D Managing New Science

In a recent Core Blog, we identified five major challenges facing R&D and IT managers in pharma and biopharma companies as they strive to equip their researchers with modern, flexible and responsive informatics tools: Managing New Science Dealing with Change Integrating Old and New Systems Collaboration and Externalization Harmonization and Simplification This post is the…

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Biosimilar development and bioanalytical comparability analysis using Pfenex Expression Technology with a cloud-based informatics solution

By:Diane Retallack, Ph.D., Director, Molecular Biology at Pfenex At Pfenex, we are in the business of developing biosimilars. And, as a result, on a daily basis we produce data‰Ólots of it. This data enables the team at Pfenex to rapidly demonstrate analytical similarity between a Pfenex biosimilar candidate and the reference drug product. The ability…

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New Apps for Small Molecule Analysis

Capture, analyze, and report on analytical data from a variety of instruments Analyzing registered small molecules for composition and purity is an important step in the small molecule drug development workflow.  We’ve created a few new apps that are focused on helping scientists improve and simplify the analysis process. New Small Molecule Applications We’ve added…

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Overcome Early Stage Bioprocess Data Management Challenges

Learn how a unified informatics platform can help USP and DSP teams to collaborate and optimize processes Creating a successful therapeutic agent is the end goal of bioprocess engineering. This process involves a careful understanding of the most desirable conditions for production, and then reproducing these conditions during scale-up. Frequently this data is stored across…

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Manage, Track and Optimize Bioprocess Workflows

New Bioprocess Applications Available for the Platform for Science Paying attention to your data and reacting to what it is telling you is essential for optimizing both upstream and downstream bioprocess workflows. In fact, it’s the key to helping your plant or lab operate to its full potential. New Bioprocess Applications A new set of…

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