As the biopharmaceutical market evolves, new forms of manufacturing partnerships are required beyond the typical in-house or outsource models. Timelines are shorter, regulatory guidelines are changing, and strategies for market entry become more diverse. How do you best secure capacity if you launch with one indication, but have clinical trials for two more in the pipeline?
A successful internal build relies on a business case designed to meet the forecasted demand within the company. This is a challenging exercise, as uncertainty is high and situations with underutilized facilities or out of stock product need to be avoided at all cost. Also, there is the time factor. An internal build may take 4-5 years and in addition to that comes the ramp up time before you reach full capacity.
The traditional CDMO model can be a faster, attractive option. However, what if your company prefers ownership and increased control? What if your pipeline looks promising or your molecule becomes the next blockbuster? In those situations, does your CDMO have enough capacity and flexibility to accommodate your current and future needs?
Where the traditional business models do not fit perfectly – the best solution often lies in innovation. If neither in-house, nor outsource fits – then look for an option that combines the best of both worlds.