When reaching the phase of bringing a project to your chosen contract research organisation (CRO) or contract development and manufacturing organisation (CDMO), it’s easy to just consider your side of the process. But the CRO/CDMO is there to help your development or manufacturing project succeed and their advice should be utilised effectively.
In the third of this three-part blog series, aimed at helping you get the best out of planning your small-scale GMP API manufacturing or chemistry research project, we look at how to use your contract service provider’s expertise to aid your project’s needs.
1. Understand their expertise
While a strong aspect of the contract services industry is moving in the direction of a ‘one-stop shop’ model, it’s important to remember that many CROs and CDMOs still offer very specialist technical knowledge and services. Get to know the areas that your CRO/CDMO partner particularly excels in and use their expertise to your advantage. Once you have agreed your project’s aims and objectives, your contract services partner will be able to guide you through the next steps, drawing on their experience, track record and technical know-how.
2. Use their experience to identify obstacles
Due to the complex nature of drug development, there will inevitably be some obstacles that you may encounter. The good news is that it is likely that your contract service provider has had to overcome many of these before. Thanks to the project team’s experience, you should be able to rely on your CRO/CDMO to identify potential challenges early and provide alternative strategies to achieve your project’s objectives.
However, it is not always possible to predict every problem – for instance, there might be a delay with your toxicity results or additional development work might be required. It is worth understanding how flexible the CMO/CDMO is prepared to be. For example, would they be willing to pause at a useful intermediate rather than continuing to a potential API that has been discarded? In these instances, the CRO/CDMO will carefully consider the best course of action and share their advice with you.
3. Agree a timeline
Having considered your key drivers [insert link to post 1] and found the balance between quality, time and cost, the CRO/CDMO will be able to draw up a realistic and achievable time plan. This should include all stages of the project, from the initial planning meetings right through to project completion.
Facilities and resources can be allocated ahead of time if the full program requirements are communicated to your partner from the outset, so be sure to discuss these early on to maximise efficiency. A good CRO/CDMO partner will explain how and why they have planned the timings for each of the steps in your project and will be able to take a more pro-active approach if they have knowledge of the full project requirements, for example if you wanted to scale up to GMP manufacture.
4. Listen to the CRO/CDMO
When starting your project, you may have certain expectations in mind and know exactly the route that you want your project to take. Remember that the CRO/CDMO has technical expertise and has probably seen a project like yours several times previously so take heir advice on board. Doing so will ensure you get the most out of your project and that it runs smoothly and efficiently. Working closely with your CRO/CDMO partner in an open way, with both parties aware of each other’s pressure points, is likely to lead to a successful outcome.
Now you know the key considerations when choosing a CRO/CDMO for your small scale chemistry research or GMP API manufacturing needs, we hope that your project will be a success.
If you would like to take a look at the previous posts in this series, you can read up on choosing a CRO/CDMO here and how to establish your key project drivers here.
If this post has got you thinking, please feel free to contact us with any questions.[addtoany]