Quality Attributes For Strategic Small Molecule API Partners

Author: Tom Wilson, Contract Manufacturing Lead

Mar 2021

Manufacturing partners become more strategic when they find ways to innovate and increase the value of your molecule or formula. It’s that kind of ongoing advocacy and support that sets one small molecule API contract development and manufacturing organization (CDMO) apart from another. 

The accelerating nature of pharmaceutical development along new and exciting routes means developers are relying more on external partners to execute process development and manufacturing. However, finding partners that possess the culture and capabilities that work best for your project can be a challenge.  

Tom Wilson, Contract Manufacturing Lead at Pfizer CentreOne, offers insights for picking small molecule development and manufacturing partners based on the following strategic quality attributes (SQAs): 

1. Experience accelerating routes and commercial timelines 

The more experience an API manufacturing partner has with tech transfers and scaling critical processes to meet commercial production targets, the more likely the batch and the program will be successful.   

2. Development and manufacturing leadership 

You will have more confidence in your decision if a potential partner is setting process and manufacturing efficiency trends, rather than following them. Not every CDMO has the same emphasis on operational excellence nor the capabilities to successfully deliver today’s hard to make molecules and formulations. 

3. Experience in robust process development 

Small molecule development routes are increasingly complex, requiring sophisticated science to commercialize cost effectively. Robust process development experience is a prerequisite, and partners adept at problem solving, refining chemical synthesis, and unlocking process bottlenecks will more effectively support product strategy goals in the long run.  

4. Focus on sustainability 

Partners that provide more stable chemistries and efficient batching are more effective on a long term basis. Those with specific experience optimizing processing methods and reducing/recycling intermediates and remediating hazardous by-products are also worth a closer look. 

Partnering with CDMOs that live core sustainability principles of reuse, recycle and reduce – will not only cut SQA emissions, it will help cut overall program costs as well.  

6. Quality and operational excellence 

Achieving critical quality attributes with consistency and transparency across the batch process is a prerequisite for any strategic manufacturing relationship. This SQA is a clear indicator of the potential strategic value that partners can bring to the table. Be sure the technology you are leveraging with your partners is as advanced as your formulation. 

Final thoughts 

Market and development trends are driving pharma to engage commercial API manufacturing partners more. The success of any commercial drug program increasingly pivots on the organization, its people, and their combined technical and operational capabilities. For success to add up more reliably, find partners that can deliver SQAs consistently and collaboratively for best results.