Four Challenges That Stall Advanced Therapy Development (Plus Four Solutions That Accelerate It)

There are many factors that can influence speed-to-market for advanced therapies, and while many contract development and manufacturing organizations (CDMOs) have attempted to position themselves as “flexible” or “agile” within the greater biologics landscape, finding a manufacturing partner that possesses the capabilities and capacity to offer a truly end-to-end development and scale-up requires an exploration of the fundamental considerations that can make or break the pathway to an approved therapy.

From project launch and proof of concept to clinical trials and commercialization, the factors that influence a drug’s ultimate viability are both vast and varied. Many challenges can stall an advanced therapy’s development, the vast majority of them tied to inadequate preclinical planning and partner vetting. By working to optimize variables such as plasmid and vector design, yield, analytical development, and production pathway early, and by prioritizing downstream considerations such as final regulatory package as early as possible, drug developers can prevent issues before they arise and avoid the rework and delays that can torpedo timelines and derail development.

By “beginning with the end in mind,” companies can foster a better development strategy, avoid the complexities of managing multiple CDMO partnerships or multiple tech transfers, and create efficiencies through platform technologies and analytics. This can be achieved by avoiding the biggest obstacles inherent to each phase of development and by prioritizing opportunities that enable greater scalability, affordability, and flexibility for a manufacturing paradigm.