The data challenges of research & development and collaboration
In the biopharmaceuticals industry today, only 13 percent of therapeutics that enter Phase 1 of clinical trials go on to launch1 – and the total journey from R&D to market can be anywhere between eight and 12 years.2
Although the industry is showing no sign of slowing down its developments, the greatest challenge remains delivering novel, high-quality therapeutics to patients faster and more cost-effectively. The industry is at a crossroads between the rise in new technological and biological innovation trends, the growing set of data integrity regulations and approval policies, and increases in operative costs.
The production of large biological molecules is a complex process with a series of bespoke inputs, potential post-translational modifications, and a need to refine development and production methodology on an individual basis. Companies must therefore not only focus on the product quality (to ensure the product isn’t modified and is aiming for the correct target), but also guarantee the quality, sustainability and repeatability of those inputs and raw materials that are required. But how do organisations demonstrate and certify this?
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