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What Are Process Development Services?
Process Development Services
Process development (PD) services play an important role in ensuring a therapeutic is adapted to a strong platform that is scalable and creates a blueprint that delivers optimal yields and productivity. Investing time and money in PD services ensures rapid development of your manufacturing process that will accelerate your drug to market.
Why Do I Need Process Development Services?
Industrializing a therapeutic is a complex and challenging journey, which becomes more difficult when the constraints of equipment scalability are not considered early on in process development.
Emerging therapeutics , such as gene, virus-based or cell-based therapies are typically born at academic or start-up company level and there may not be a clear roadmap to scalable and reproducible manufacturing processes. Such a gap introduces the risks of batch failure or issues in scaling up to commercial production in the accelerated approval timeframe associated with these emerging therapeutics.
Recent advances in technology mean that operating a continuous manufacturing process with a smaller footprint is now also a desirable option that should be considered at PD stage. However, producing multiple biologic and biosimilar products in a single facility using continuous processing can be a challenge. The correct PD partner will help you evaluate batch versus continuous processing and will work with you to determine the right option for you and your product. Getting to clinical trials with a process developed in academia or at start-up level is typically not economic and could have negative long-term consequences to your bottom line.
How Will Process Development Services Help Me?
Investing time and effort in your process development will alleviate pain points when it comes to scaling your project to clinical manufacturing.
PD services can help you develop a platform that can be deployed with multiple drug candidates. This saves you both time and money since you will not be required to ‘re-create’ the wheel for each one of your therapeutics. Working with your chosen PD services partner will help you to adopt a platform that can deliver a complete, customized process which can improve process reliability and decrease facility footprint.
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