Choosing an API development and manufacturing partner: key considerations

The factors you should consider when identifying and selecting a partner for your next API manufacturing and development project.

Selecting the right contract services provider is a vital step in the overall success of a GMP API manufacturing project and partnership. So, what should you look out for before outsourcing to a CDMO partner? Follow our top tips…

Communications and cultural fit

Choosing a pharmaceutical outsourcing partner can be a very overwhelming and intimidating decision for sponsors. With many different aspects to consider and evaluate before taking the leap, it is important to not under-estimate your gut instincts. A compatible cultural fit between the pharmaceutical company and the CDMO of choice is vital to a successful partnership.

Communication strategies should be clearly established on both sides of the relationship so that project expectations can be managed appropriately from the outset. As such, clear roles and duties should be suitably delegated. Doing so increases the likelihood of meeting a project’s overall timeline and budget.

Know your project’s requirements

Understanding your project’s requirements is crucial to compiling and shortlisting potential partners. After all, you want to secure a perfect match for your project. In order to do so, you should evaluate your project to determine the make-or-breaks of a partnership; compatibility is everything.

As well as understanding your own project, it is the job of the CDMO to add value at the request for quotation (RFP) stage and proactively get to know your requirements. During these discussions, they should take a consultative role, suggesting alternative strategies and using their knowledge to add value to the process.

When scoping the parameters of your GMP API project, here are some questions to ask:

  1. Does the CDMO’s core capabilities lie within your chosen area?
  2. Will they give you access to the whole team, including direct access to chemists who understand your molecule?
  3. Are they willing to give you references?
  4. How well integrated are the CDMO’s solid-state capabilities?
  5. Does the CDMO take a phase-appropriate approach to API development and manufacturing?
  6. Does the CDMO have a dedicated team to develop and validate analytical methods during API development, as well as handle GMP release?
  7. How does the CDMO deal with failure and handle problems?

A customer perspective

Don’t just take our word for it. We recently spoke to our customers to find out more about important factors when selecting a CDMO partner. Of course, resource and capability were both critical and were cited by 83% of those we spoke to. Flexibility and quality also came out on top, with two thirds of customers highlighting the importance of setting expectations early on in any partner relationship as key to project success.

In summary

So, do your homework, trust your gut and carefully consider all aspects of the relationship from the outset of the planning process.