Choosing the Right Process Development Partner
November 21, 2019
Are you looking for a process development (PD) partner but not sure where to start? This blog provides guidance with 5 top tips to help you choose the right PD partner that can help you.
Companies specializing in process development offer a wide range of services, and not all providers are equal. Some specialize in early-stage PD, others have deep expertise in scale-up, whilst others offer the full gambit of development services including early-stage development through to pre-clinical, clinical and GMP manufacturing.
- When evaluating potential partners, the first step should be to gauge where you fall in the PD journey. This analysis will reveal what type of service you require. For example, if you have not screened and established the best media and cell line, then you will likely need partners who have expertise in early-stage PD.
- While assessing partners, ask for details of their expertise. Use this information to create a list, and compare it against your current process needs. Deep dive into their claimed competencies to understand whether these are based on in-house knowledge or are they leveraging outside vendors, such as cell line development.
- If you are outsourcing early-stage process development, find out if the partner has capabilities to industrialize or scale-up the process. Ensure that they have the necessary facilities and equipment required to scale-up your process.
- Depending upon your internal expertise and needs, it might be necessary to engage a partner that can provide regulatory guidance and one that possesses the capabilities to manufacture your drug product under GMP processes. These capabilities are associated with cost, so it is important to evaluate your needs and balance them with your overall budget.
- In many cases, it is sensible to initiate your early PD with a skilled organization that has extensive expertise in early stage PD and industrialization of processes. This can save on cost and can be especially attractive if the chosen partner has strong working relationships with contract manufacturing organizations (CMO). This will help the provider to seamlessly transfer the optimized industrialized process into their facilities.
Choosing Pall as your PD partner will reduce your development time by leveraging our industry experts, proven methods and award-winning integrated bioprocess equipment. Discover more in the video below.
Learn more about what to expect when outsourcing process development, in the blog post by Dr Ruta Waghmare.
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Albert Mirzoyan - Business Manager, Biotech Process Development Services
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