Newsletter | November 5, 2020

11.05.20 -- Accelerating And Optimizing Biologic Drug Development And Commercialization

Leveraging Innovative Technologies, Best Practices, And Strategies To Accelerate Biologics Development And Commercialization

Gain insight into how practical implementation of innovative technologies and solutions, such as the multi-attribute method, modernized cell line development workflow using high-yield cell lines and automated systems, as well as next-generation purification resins to help accelerate biologics development and commercialization.

Multiplexing: Managing Risk With Proven, Single-Use Solutions

Typically, demand forecasts for drugs prior to launch reflect a huge range of expectations. This illustrates just how hard it is to forecast accurately. Instead of trying to make better predictions (which will never be wholly accurate or truly able to remove risk), or erring on the side of overcapacity (which is a drag on ROC [return on capital]), developers and CDMOs should seek manufacturing flexibility.

Process Characterization And Validation For Biologic Processes

Even during the early drug discovery process, there are valuable opportunities to simplify the path to commercialization. Using a risk-based approach to generate an appropriate control strategy will help ensure your product meets regulatory requirements, enabling timely approval and launch to market.

Implications Of Inaccurate Forecasting On Biologics Manufacturing

Large molecule drug substance manufacturing and demand forecasting is riddled with complexity. Inaccurate demand forecasts can have significant implications for companies developing biologics. Furthermore, it is increasingly difficult to locate capacity to respond to demand changes.

The Right Biomanufacturing Partner Can Mitigate Forecasting Risks

While forecasts can never be 100 percent accurate, the goal for biopharmaceutical forecasters should be to minimize the degree of inaccuracies as much as possible. To reduce the impact of inaccurate forecasting over the life cycle of a product, companies need to focus on those variables that they have the most control over.