When Does it Make Sense to Use a CDMO for API development?

Key Considerations and 6 Questions to Ask

Posted: July 1, 2019

API Manufacturing and Pharmaceutical Manufacturing

So you have a breakthrough molecule you need developed, investors breathing down your neck and it’s urgent you see this drug through to commercialization as efficiently and quickly as possible.

The immediate reaction may be to mobilize a manufacturing team, put the infrastructure in place and make this project the top priority at the expense of all other development initiatives. But not so fast – before undertaking such a big endeavor, it’s important for companies – regardless of their size – to consider if going it alone is the best model or if by working with a Contract Development and Manufacturing Organization (CDMO), they just may be able to reach their goals more efficiently and economically.

Clearly, the CDMO route is an attractive option. In fact, The global Business Process Outsourcing (BPO) market, is expected to reach USD 343.2 billion by 2025, according to a study conducted by Grand View Research, and the pharmaceutical manufacturing market is a key contributor to this growth.

The Case for In-House API Manufacturing and Development

Despite this trend, there’s clearly a role for in-house development and manufacturing. For large pharmaceutical firms that already have the capacity and infrastructure in place it might make sense to keep it in-house, without the added investment of a CDMO.  Likewise, because of security concerns and regulatory requirements, large pharma firms can be reticent to adopt CDMO models, which can have operations scattered across multiple locations and which may not share the same security protocols and other corporate controls that the large pharma firm may have institutionalized. And, when it comes to smaller firms that simply want a one-off small batch of an API, it may not be concerned with adherence to current Good Manufacturing Practices, so the use of a highly qualified CDMO may be overkill. 

The Growing Role of Outsourcing

Yet the decision to develop and manufacture in-house is fast becoming the exception, as the complexity of drug candidates rises, and cost pressures increase. Many pharma firms are turning to CDMOs to reduce capital investment and gain valuable specialized expertise without having to hire expensive, highly specialized scientists and other professionals. And, with a CDMO, sponsors get access to advanced technologies, equipment and facilities that would be hard to justify purchasing for perhaps an isolated project.

Another consideration is the supply chain. A qualified CDMO can take care of the end-to-end supply chain to free up a sponsor from having to manage  inventory and logistics. And of course, CDMOs offering integrated services, can help reduce time to market by performing all steps under one roof.

Perhaps one of the strongest cases for working with a CDMO may be the sheer volume of projects it may have been involved in. The knowledge gained, insights gleaned and combined expertise of many scientists, working on multiple projects can fast-track development projects, helping to avoid costly mistakes and sharing best practices that can ensure a greater likelihood for successful projects.

Despite the efficiencies gained when working with a CDMO, there’s no question that The development of an API can be a costly and time-consuming process. One way to ensure that costs are more effectively managed is to work with a single or a minimum of a few CDMOs on a specific project. Having to transfer methods, knowledge and other information from one stage to the next can not only cause delays, but it can make your project vulnerable to errors in transfer.

How to Pick a CDMO

With these considerations in mind, and determining that the CDMO route is the way to go, the next decision is choosing which CDMO to use. Despite a growing consolidation in the CDMO market, each CDMO has specific strengths and areas of expertise so it pays to do your homework and make sure the firm is the right fit for you. Aside from the specific questions about technical expertise, key questions to ask, may include:

  1. Where are you located? It’s always a plus to work with a CDMO that is close by, where inspections can easily occur and where regular meetings and collaboration can be facilitated.
  2. How many similar projects have you handled? Expertise in your specific project can be priceless when it comes to smooth operations and a good outcome.
  3. How do you handle problems in the plant? A CDMO that is transparent and provides regular updates, and that can also keep a level head when problems arise should be on the short list.  
  4.  Can you share with us your SOPs?  A reliable CDMO will be able to explain its standard operating procedures, protocols that enable adherence to cGMP and other information demonstrates a commitment to quality. 
  5. How many projects do you do on annual basis? Understanding that 90-percent of projects undertaken never reach the pharmaceutical market, it’s important to ask how many projects the CDMO undertakes in a year and how many projects have been commercialized. While the reasons that a project does not receive FDA approvals can be completely unrelated to the capabilities of the CDMO, the more projects completed successfully means more best practices that can be leveraged for your project.
  6. What is your turnover rate? Contrary to traditional thinking, some level of turnover among QA and other staff can actually be a good thing, since new talent can invigorate the whole team, providing new approaches and new ways of doing things.  This thinking, however, should not cross over to the R&D team, since any disruption in the scientific team means loss of intellectual property and loss of valuable time.

Whether you choose to work with a CDMO or go it alone, the journey to API commercialization can be a long one and selecting the best route to the finish line is no easy task. Companies need to consider all options and pick the route that makes the most sense – strategically, financially and in terms of product quality and safety.

About the Author

Ed Price CEO of PCI Synthesis
Ed is President & CEO of SEQENS North America (formerly PCI Synthesis). He serves as a co-chair of the New England CRO/CMO Council and sits on the Industrial Advisory Board for the Department of Chemical Engineering at UMass, Amherst. Ed is also a long standing member of the American Chemical Society and advises the Bulk Pharmaceutical Task Force of the Society of Chemical Manufacturer’s and Affiliates (SOCMA)...

Do you have questions? Talk to Ed.