Biopharma firms function in a risky development environment with compressed timelines and budget constraints. Companies often overlook critical factors that could delay or suspend efforts down the road. Consultants should help clients understand five key risks in order to avoid costly problems and maximize financial returns during the development process.
Consultants play a critical role in ensuring the long-term success of small biopharmaceutical companies, though much of their work happens behind the scenes. From lifecycle planning to marketing advice, consultants help fill gaps in knowledge while having their fingers on the pulse of new production strategies that might be a fit for clients.
Large molecule drug substance manufacturing and demand forecasting are riddled with complexity. The long cycle time and short shelf life of a biologic drug substance make it difficult to adapt the supply chain with agility, even at the earliest stages of development. As a result, inaccurate demand forecasts can have significant implications for companies developing biologics.
In light of the rapid growth of development of biopharmaceutical products, regulatory changes and tightening capacity access, choosing partners who can offer greater flexibility to respond to inevitable changes in demand is among the best strategies to mitigate risk.
Overestimating demand when planning biologic drug substance production can lead to higher costs and disposal expenses, while underestimating demand can result in missed market opportunities. As a result, biologics companies are increasingly demanding modular and disposable technologies and continuous manufacturing because of the need for flexible capacity.
