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European Biopharmaceutical Review

The Numerous Challenges of a Rapidly Developing Sector

Farmers have manipulated agriculture and livestock for thousands of years. It’s no surprise, then, that discovery and development are the primary goal of each of the four biotechnology markets, including:

• Bio-health: Bio-health companies are hyper-focused on the R&D portion of the medical sector. These companies take significant risks to design new drugs quicker and more effectively. Bio-health thrives ‘behind the scenes’, starting with foundational research to product launch instead of marketing or sales
• Agri-biotech: Ground-breaking agricultural advances have always played a vital role in agri-biotech. For example, scientists successfully cloned the first mammal in 1996 – a sheep named Dolly. Aside from animal cloning however, agri-biotech pursues crop improvement by crop cloning, modifying genes, and more. Many farmers thrive on transgenic and bioengineered crops, too
• Bio-energy: The biotech industry solves environmental problems by studying natural environments. The bio-energy market studies microorganisms and works to create a more sustainable and preserved world with less pollution
• Bioindustrial: More than for medicine, food, or energy, biotech focuses on non-food uses of crops and other products. The bioindustrial market can transform unpalatable raw materials into edible food. Additionally, the biotech industry’s advances have extended the shelf-life of many foods based on innovative packaging and product storage

Navigating the Legal Climate of Biotech

Plenty of legal issues surrounding the biotech industry are cause for concern with those involved in the space. Furthermore, each legal layer, or apprehension, indirectly contributes to the complexity of this market. There are vulnerabilities abound, but players tend to weigh their options differently than in any other industry.

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Carl Niedbala is the Co-Founder and Chief Operating Officer of Founder Shield, a boutique insurance brokerage specialised in serving emerging industries and the life sciences sector. Founder Shield works with forward-thinking insurers, and focuses on using technology to deliver top tier service and results. Carl’s experience began in high school when he developed and submitted United States Patent Application 20050277574, published 15 December 2005. Carl studied finance and marketing at Villanova University, US, before attending the Temple Beasley School of Law, US. After working for several venture backed start-ups and venture funds, including Dreamit Ventures and biotech-focused Originate Ventures, Carl co-founded Founder Shield.
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Carl Niedbala
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Quantitative NMR (qNMR) is a technique that is being applied broadly and at an increasing rate in the field of pharmaceutical analysis (1). This white paper highlights the advantages of using qNMR to determine Relative Response Factors (RRFs) for pharmaceutical impurities detectable by HPLC. A single determination of RRFs using qNMR allows for simple and accurate quantitation of impurities which eliminates the need for preparation, qualification, and storage of reference standards. An example is presented here, which demonstrates quantitation of known impurities that have variable responses to UV-VIS detection, thereby providing a more accurate assessment of impurity levels than UV-VIS response alone.
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BIO-Europe Digital

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Global connections are more important than ever. With the same powerful one-to-one partnering and valuable content, BIO-Europe Digital continues to help you drive your life science partnering forward.
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