What Are Process Development Services?
April 18, 2019
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.
What Problems Can Process Development Solve?
A PD service provider will address multiple challenges that you may be facing. This includes entire process industrialization, limited pool of resources and technical expertise, and platform complications. These problems are particularly prominent in emerging therapeutics such as gene and cell therapy, as well as in emerging technologies such as automated continuous bioprocessing.
What Will a Process Development Partner Do for Me?
A PD service provider can either simplify your current process or work with you to re-develop it from the ground up. They will then work with you to translate the process into a fully integrated and scalable platform paving the path to industrialization.
Your PD provider will help you in selecting an ideal platform, process characterization and consistency runs. They will work with you to develop comprehensive manufacturing protocols. Your PD provider will also optimize your process for production and scale, helping you achieve process performance, commercial viability, and compliance with regulatory and quality requirements (for both- process as well as manufacturing scales).
What Should I Expect from a Process Development Partner?
You should expect the provider to place a strong emphasis on open and collaborative dialogue. The team should first listen to your needs and ideas and then align on your research objectives. To ensure success, you can expect on-site support, training, and documentation from their experts to either your team or designated CMO.
Partnering with a process development provider that has a strong track record of technical expertise, developing a multistage process, as well as delivering on time; will help you to navigate some of the complexities associated with bringing a drug to market.
Ensure due diligence in selecting your potential PD partner and pay close attention on whether they place a top priority on speed, quality, and open and transparent communication. These factors will put you in a stronger position to achieve your end goal and minimize risks.
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Ruta Waghmare – Vice President, Scientific Affairs and Laboratory Services
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