What Are the Drawbacks of Outsourcing Process Development?

Outsourcing process development (PD) can provide a simplified, accelerated, and more robust route to drug development and commercialization of your therapeutic. This is particularly advantageous for companies that have limited resources and/or expertise within this space. However, there are potential challenges that should be considered before choosing an outsourcing partner to help scale-up your processes.

Limited Funds

If funds are limited, it is important to identify the correct partner organization that will understand your limitations, and who will meet your needs. You may not require a cGMP process in early stage development. If this is the case, you can choose a reputable partner that can provide process development activities at a lower cost.

Technology Transfer

Technology transfer of your process to the PD partner and back to your chosen site of manufacturing can be challenging. This is especially true for cell-based assays used to evaluate yield and product critical quality attributes. These assays are notoriously known to generate results that can vary widely. Extra care should be taken to meticulously provide raw materials of the highest quality to your partner and invest in their success by providing proven protocols and technical assistance as required.

Clear Communication and Trust

There is a certain level of trust that needs to be established between the outsourcing group and the contracting PD team. Projects can run the risk of failure if a common understanding and acceptance of roles and responsibilities of each group is not established. In a truly collaborative project, both sides interact in an open and candid manner. In this environment, tough questions are asked by both sides and they are discussed openly. This type of collaborative atmosphere is sometimes difficult to create, however, if done successfully, the projects likelihood of success will improve significantly.

When a project is outsourced, the outsourcing group is naturally expected to relinquish a reasonable portion of control of project direction to the PD team. This can be a difficult proposition for some groups, especially if unforeseen or undesirable results are obtained during experimentation.

Unexpected Challenges

Many projects can experience unexpected challenges, and the experimental outcomes do not generate predictable results. Sometimes these results are viewed as failures. However, it is important to recognize that these types of challenges are a natural element of process development work with biological systems. Many of these findings often lead to the greatest process improvements.

Most organizations have established platform technologies that they prefer to use in their process development projects. This approach has pros and cons. The positive aspects associated with this approach are that the group has a significant amount of expertise with the platform technology and this can increase probability of success. In contrast, an affinity for a preferred platform may invoke a perception of real or supposed bias.

Although there are potential pitfalls that can be encountered when outsourcing your process development activities, these can be overcome with the right PD partner. If you carefully select the correct partner organization, and cooperatively develop a focused plan for your process development project, you will find that the pros of outsourcing your process development significantly outweigh the cons of this approach.