R&D and Process Development

Industrializing a desired product 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 desired products 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 Process Development stage. However, producing multiple biologic and biosimilar products in a single facility using continuous processing can be a challenge. The correct Process Development partner will help you evaluate batch versus continuous processing and will work with you to determine the right option for you and your product.

Investing time and effort in your process development will alleviate pain points when it comes to scaling your project to commercial manufacturing.

PD services can help you develop a platform that saves you both time and money since you will not be required to ‘re-create’ the wheel for each scale up. 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.

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 API, Biopharma, Nutraceutical manufacturing as well as in emerging technologies such as automated continuous bioprocessing.

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 downstream process and scale-up, helping you achieves process performance and commercial viability

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 support/lab trials, 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 desired product to market.

The commercial application of technology developed in the laboratory to industrial application requires the scaling up from the bench scale (0.1 to 1L) to the industrial scale (10,000 – 1,000,000+ L), representing an increase of 10,000 to 1,000,000+ X, presenting a number of scale-up, process, equipment design, and technology risks. The incremental scale up of process technologies to the pilot scale demonstrates the scalability of the technology and reduces the risks & costs associated with commercialization.