Balancing Speed, Cost, And Risk In The Race To Market
The role of small biopharma companies has changed drastically over the last decade. What were once companies struggling to find their place in an evolving industry are now a driving force that serves as the innovative engine for drug discovery and research. However, with motivation fueled by the need to reach funding milestones quickly and the pressure for a cost-effective manufacturing process, small biopharma companies often lacking in-house resources must define a strategy that keeps risk low but also accelerates their process development. Even midsize pharma companies with more internal capabilities struggle to develop such a strategy and to manage a pipeline of molecules with multiple assets and projects.
There is no model to predict how a molecule will behave, though, so the work done during process development is a key factor in the success of your program. Analytics is also an essential component of regulatory compliance and quality stability during scale-up across all clinical phases and commercialization. As a small or midsize company trying to move quickly to get ahead, you could jeopardize your chances of success by working too fast to develop a process that works well in the clinic but ends up facing difficulties later.
That is why, in this e-book, you’ll find insight and advice from our team of experts about how to leverage strategic approaches to process development and risk management while meeting strict timeline and regulatory requirements. Our purpose is to provide you with the guidance you need to make strategic choices for effectively manufacturing your molecule without impacting its long-term success, ultimately delivering high-quality drugs that meet patient needs quickly and safely.