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Taking care of your API: what to ask your CDMO

By Justin Divan October 2019, General CDMO

To ensure that your CDMO can manufacture your custom API in a reliable and effective way, it is always important to establish a strong collaboration from which to launch this important relationship. To start strong, it’s important to ask a few key questions from the very start of your proposed partnership.

Does your CDMO anticipate problems before they occur?

By identifying issues up front that can occur during a custom API development and manufacture project as soon as possible, the prospects for your CDMO keeping your project on track become much greater. To recognize problems from the beginning, your partner should perform your process at lab scale to demonstrate the process as designed.

By accomplishing such due diligence early in the relationship, the team handling your custom API can launch your project better a baseline and measure improvements against it from the start.

Can your CDMO reliably optimize its processes for scale-up?

When it comes to scaling up API, multiple issues can occur on a larger scale. To give one example, a slight emulsion observed at lab scale in a round bottom flask can become problematic to handle in a 16,000 L reactor. Some API manufacturing processes can even be dangerous on a commercial scale, with potentially explosive effects.

To overcome issues related to scale-up, an effective CDMO partner should conduct lab-scale assessments, then evaluate and potentially redesign the production process and confirm by a proof of concept study. This is a key element of the collaboration and likely to resolve most problems before they even occur.

Can your CDMO work to an effective timescale?

Delays of any kind can be frustrating, especially so when outsourcing a custom API, because so much of drug strategy depends on it and costs can mount quickly. Most understand however, that the worst delay comes from a failed batch.

To ensure that your project stays within your allocated time frame as much as possible, your CDMO should determine the boundaries of your critical process parameters and optimize your reaction conditions to ensure that the process is robust. When possible, the work should be done at laboratory scale as soon as possible, before moving on to pilot scale or commercial production. This will help to avoid costly and time consuming repeats.

Is your CDMO considering the impact it has on the environment?

Although it is vital to make sure the CDMO you partner with has the capability to handle your custom API project effectively, it is becoming increasingly important for many organizations to understand how their contractors are making their drugs and choosing environmentally conscious CDMOs to manufacture them responsibly.

Here at Pfizer CentreOne, for example, we developed a progesterone synthesis based on green chemistry principles that is designed to reduce hazardous solvents, greenhouse emissions and waste. By pursuing initiatives like this, we can reduce the carbon footprint of the products we manufacture for customers.

Ask your potential partners what initiatives they’re undertaking to reduce, re-use and recycle harmful volatile solvents at their sites, and the chemistries they use to ensure that the manufacture of your API will have less of an impact on the environment.

Are you being direct enough from the outset?

Don’t be afraid to ask your CDMO direct and probing questions, especially at the start of the relationship. It is imperative that potential outsourcing partners can assure you they are prepared to optimize your synthesis process and key regulatory findings to ensure the seamless scale-up of your custom API in an economic, timely fashion.

You might also ask how their teams overcame past issues relating to manufacturing APIs similar to the one being proposed. In light of the time and costs associated with custom API development, it’s critical you select CDMO partners with specific expertise and experience working through problems that your target compound or molecule might encounter during commercial development.

It is also important to understand your partner’s maturity of their quality systems and how length of experience of their development scientists. Education is good but experience will always triumph when finding solutions for complex chemistry.

It is also important to ask prospective CDMO partners how they work with your technical team. No matter how experienced your contract manufacturing partner is, they’ll need to collaborate with you closely if your important project is to be a success.

Whichever CDMO you choose, they need to be anticipatory and proactive if they are going to successfully overcome the hurdles associated with the custom development, scale-up and manufacture of your API.

By asking a few simple but direct questions, anyone tasked with choosing a custom API development partner will have a better chance of selecting the best fit for your custom API project.

Let’s collaborate. Contact our team today to find out more about how we can help you make a success of your next custom API project.