How is the Pharmaceutical Industry Shifting?
There’s no doubt that the declining number of blockbuster drugs on the market has caused a dramatic change in how pharmaceutical companies operate. As the industry begins to realize that a blockbuster-driven strategy is not in and of itself sufficient to drive growth, drug companies are starting to move away from the one size fits all’ approach towards more personalized medicine: focusing on the niche-buster model and smaller markets characterized by a high unmet need.
This shift has and will continue to increase the complexity of manufacturing operations because a larger number of new products will have to be transferred from R&D and validated on a commercial manufacturing scale, either in-house or at a Contract Manufacturing Organization (CMO) facility. Further, in order to relieve capacity for new products, the need to transfer legacy products to a CMO will rise. Because of this, companies will need to be more flexible, nimble and collaborative in order to gain advantage from more complex, virtual operations that are a result of an increase in the breadth of their product portfolio.
What Are the Risks of These Shifts?
The process of transferring products is called Technology Transfer – defined as the transfer of any process, with its documentation and professional expertise, between development and manufacturing or between manufacturing sites. Specifically, it involves the transferring of technologies, manufacturing processes, analytical test methods, production specifications, and packaging processes. Nonetheless, this is a highly complex process with intertwined workstreams, and it has its fair share of risks along a product’s journey to its new home. These risks include:
- Information kept in silos due to respective sites working independently
- Inefficient and potentially inaccurate tracking transfer stages and deliverables via email and spreadsheets
- Undefined or poorly traced approval processes
- Inconsistent or unorganized storage of documents needed for knowledge transfer
- Potential for rework if study and validation batches are not designed properly due to lack of knowledge transfer or miscommunications
If these risks are not properly mitigated and delays occur, the business can be impacted by lost revenue from supply delays, lost revenue from high transfer costs, and decreased profitability as a result of lower product quality.
In a post coming soon from our Customer Experience team, learn how you can take practical and effective steps to confront these challenges and minimize risks.