Sarthak Prasad Sahoo, Sonali Bhujabal
A hypothesis, that the life-saving drugs may face the manufacturing hurdles with billions in sunk costs, years of delayed periods and some sets of regulatory conflicts, can never be ignored as the biopharmaceutical world is presently suffering by a lower success rate of novel biologics development (commonly below 10%), an unwanted stretched time line spanning over decades and a huge investment for the whole manufacturing. To facilitate faster therapy to the patients, integration of AI-ML techniques, replacing expensive and extended preclinical trials with decentralized and innovative trials are to be adopted on a quicker passion. The resilience and agility can further promote the manufacturing frontiers to follow green processes, modular continuous platforms and digitally integrated supply chains. Not only innovations, but efforts are also required to upgrade the workforce with latest skills, to facilitate balance to move forward with both sustainability and affordability and to come forward with globally harmonized regulations. Keeping all these aspects in mind, the present content is so framed to pile up all the major challenges related to biopharmaceutical industry in one place and to come up with some viable solutions coupled with ethical oversight, transparent communication, and equity-driven distribution. This approach may also be helpful in redefining the scopes, transforming the barriers into promoters and facilitate the industries not only to deliver innovative drugs but also make them available for the service of mankind on the global level.