Why do I need bioprocess 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 biomanufacturing process with a smaller footprint is now also a desirable option that should be considered at development stage. However, producing multiple biologic and biosimilar products in a single facility using continuous processing can be a challenge. The correct bioprocess development collaborator 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 a start-up level is typically not economic and could have negative long-term consequences to your bottom line.
How will bioprocess development services help me?
Investing time and effort in your bioprocess development will alleviate pain points when it comes to scaling your project to clinical manufacturing.
Bioprocess development 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 bioprocess development services collaborator 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 bioprocess development solve?
A bioprocess development 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 bioprocess development provider do for me?
A bioprocess development 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 bioprocess development provider will help you in selecting an ideal platform, process characterization and consistency runs. They will work with you to develop comprehensive manufacturing protocols. They 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 bioprocess development provider?
You should expect the provider to place a strong emphasis on open and collaborative dialog. 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 bioprocess 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 bioprocess development provider 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.