If you are considering outsourcing bioprocess development, it is highly recommended that you allow sufficient time to reach your goals.
Setting realistic project deadlines and dedicating appropriate resources to the project will be fundamental to its success.
Poor planning can cause significant delays to the developmental timeline and may even result in failures. As such, it is recommended that you balance realistic expectations with optimism when it comes to setting project timelines and risk mitigation plan.
Your chosen bioprocess development collaborator should be able to provide estimates for the project duration. First, you will need to engage in in-depth discussions about your product requirements and status of your developmental program. This will allow your bioprocess development collaborator, as well as you, to fully understand the project details and the required timeframes for each stage.
It is critical to prospectively build out a few possible scenarios for delivery of milestones. You should ensure that these strategies are clearly communicated to your leadership. Best- and worst-case scenarios should be considered, and a plan created for each. Visual project management is an extremely useful tool that should be used.
Be aware of pitfalls that occur when teams don’t account for logistics. When you are vetting an outsourcing collaborator, spend time asking questions about the team. Understand how your bioprocess development collaborator will handle logistics for your projects — specifically around processing, reporting, and communication. Ask about how they track inventory, and their reorder points both internally and with third parties.
Your collaborator should also be able to provide you with insight into regulatory requirements that are associated with shipping biologic materials. Make sure the proposed project Gantt chart accounts for logistics and clearly maps out nonscientific action items. Significant project delays can occur when teams only consider scientific action items and neglect those that are nonscientific.
So, to summarize, when it comes to outsourcing bioprocess development, there are a multitude of factors that can, and will, impact the success of your bioprocess development project and collaboration. It’s important to plan and be realistic. Include different delivery scenarios and allow sufficient time to reach your goals. Make the most out of your internal resources, tools, and visual project management. Be aware of the pitfalls and don’t be afraid to spend time asking questions.