What is process development?
Biopharma process development comprises the activities that help you create a series of steps to produce a biomolecule – a monoclonal antibody (mAb), recombinant protein, viral vector, or other product that comes from a biological origin.
Bioprocess development is often divided into upstream process development and downstream process development. Those activities must be combined with the right analytics, so you can accurately measure what you’ve identified as your product’s critical quality attributes (CQAs) as you develop and refine your processes.
Process development activities will vary by your type of biomolecule, as well as the stage of the drug development process you are in – preclinical, early clinical (Phase I/Phase II), or late clinical (Phase III/Phase IV). Regulatory requirements will guide many of these activities.
At early stages of drug development, you will develop a process that is ‘good enough’ to meet the needs of that stage. However, it’s important to keep the end goal in mind. Ultimately, you will need a process that translates to a manufacturing environment, one that is easy to scale up throughout clinical trials and to the market. By the time you reach Phase III in the drug development process, ‘good enough’ is not sufficient. Instead, you will switch your focus to making sure you have a robust upstream or downstream process that delivers a high yield and high productivity. Also, your process must be cost-effective and reproducible.
Keep the end in mind for future success
Key decisions early on will impact how you accomplish your goals. For example, a suspension cell culture is easier to scale up compared to adherent cells. And ultracentrifugation to separate empty from full capsids of adeno-associated virus (AAV) does not scale well. Consider scalability from the start to avoid the need to rework your process.
And if you make changes to your manufacturing process during clinical trials, this could impact regulatory CMC (chemistry, manufacturing, and controls) submissions and could have a negative effect on timelines further down the road. So, if you’re looking for long-term success, it’s important to take the time early on to get the process design right.
This is especially true if you’re working on a biomolecule and indication that regulators might grant an accelerated pathway to approval. By making key decisions early around process development, quality assurance, and quality control strategies, you can set yourself up for success in current good manufacturing practices (cGMP) manufacturing. Focus your efforts on making sure that your manufacturing process is robust.
Process development must balance product quality with process performance (Fig 1). Market needs for speed and economy are driving the need to make go/no go decisions earlier, as well as to bring products to market faster and at a better price point. These needs translate into growing pressure to quickly create processes that are cost-effective at manufacturing scale. When added together, gains in productivity can have a big positive impact on process economy.
Fig 1. Biopharma process development is a balancing act.
Learn more about process development
Get better understanding of definitions, activities, and things to consider when developing an upstream and downstream bioprocess
- Process development activities by stage of drug development
- Upstream process development: fundamentals
- Downstream process development: fundamentals
- Analytics: why they are important for process development
- Definitions for biopharma process development
- Regulatory: what to think about during process development
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