The Snapdragon Difference
Why invest in continuous flow?
Continuous flow chemistry has the potential to unlock a tremendous amount of value in the pharmaceutical and fine chemical industries. (For an introduction to continuous flow technology, click here.) For example, there is opportunity to capture additional product value (e.g., from lower operating costs), significantly reduce capital expenditure, and speed product development cycle times.
THE MANY BENEFITS ASSOCIATED WITH FLOW TECHNOLOGY ARE COMPELLING:
- better selectivity of desired products,
- faster scale-up,
- safer reaction conditions,
- smaller manufacturing footprints with greater efficiency and better quality,
- more environmentally friendly, and
- greater access to reaction classes that are difficult/infeasible in batch.
As a result, it has been suggested that implementing continuous flow in pharmaceutical manufacturing at scale could reduce operating costs by 30+%, which is on par with operating cost reductions in other industries that have adopted continuous manufacturing. Moreover, continuous manufacturing plants could have as much as a 25-fold smaller footprint than that of a conventional plant with comparable output. Less appreciated, perhaps, is the dramatic impact that continuous flow chemistry could have on drug discovery and development, though some commentary to this effect has recently appeared in literature. Continuous flow allows reliable access to notoriously difficult reaction classes, like photochemistry, which can build up molecular complexity quickly, enabling access to unexplored chemical space. Significantly, in the continuous flow format, these molecules could be readily scaled to accelerate additional testing for more rapid prototyping in discovery and faster product development cycle times.
What are barriers to implementing continuous flow?
Lack of regulatory guidance is often cited but a dearth of scientific expertise in flow is likely the more formidable barrier in implementing continuous flow at scale. Regardless of some companies' past investments in flow, we have observed that these companies still need support in capturing the benefits of the technology at scale.
REGULATORY LANDSCAPE REGARDING CONTINUOUS MANUFACTURING IS SHIFTING
At least for the pharmaceutical industry, lack of regulatory guidance around continuous manufacturing routes has often been cited as the key roadblock to implementation of continuous flow chemistry. The regulatory landscape, however, is shifting. Several sources indicate that there will be a fully continuous manufacturing route approved sometime in 2015. Moreover, the head of the FDA’s Center for Drug Evaluation and Research (CDER) has made public comments in support of the technology.
CULTURAL CHALLENGES DUE TO LACK OF TRAINING/EDUCATION IN CONTINUOUS FLOW
Regulatory barriers do not fully explain the relatively limited impact that flow has had in the related laboratory and fine chemical industries. We contend that there are deeper cultural challenges that exist, which have stalled the impact of the technology and will continue to do so. Chemists' education and training typically do not incorporate flow chemistry in any appreciable way. Furthermore, while industry has historically been a bastion for the development of future technologies, many can no longer afford to experiment with newer platforms while advancing their products.
FLOW CHEMISTRY IS NOT PLUG-AND-PLAY TECHNOLOGY
Flow chemistry is not a plug-and-play technology that can be accessed effectively through an off-the-shelf reactor or standard protocol. Maintaining a state-of-the-art capability is difficult and costly, and, for many companies, not currently feasible. Those who have invested in flow technology capabilities typically need help implementing flow chemistry optimally, given the complexities of the science.
FLOW CHEMISTRY SHOULD BE APPLIED EARLY TO CAPTURE FULL BENEFITS
Moreover, we have observed that companies often fail to capture flow chemistry benefits fully by only focusing on applying the technology to later-stage process development or for manufacturing purposes. At these stages, stringent timelines often limit the opportunity to optimize the specific reaction process and to apply flow in a strategically impactful way to the overall discovery and development process.
Why Snapdragon Chemistry?
Snapdragon Chemistry utilizes forefront leaders in flow synthesis and processing to increase our clients' probability of success in implementing flow chemistry to shift their competitive advantage. Our leadership and advisors are actively engaged in developing solutions that encompass cutting-edge thinking on flow chemistry and reactor technology. Moreover, we help our clients proactively identify the best opportunities to apply flow chemistry across their portfolio, from discovery to manufacturing, to maximize their return on investment in the technology. Snapdragon Chemistry has a unique perspective on how to implement flow chemistry optimally in operations, which helps our clients capture maximal benefits.
Conventional View of Flow CHEMISTRY
- Applies only to later-stage process development and manufacturing, not to discovery and early development
- Used primarily for improving chemistry on scale
- Considered a finicky technology — a “second resort” only in the case of a serious challenge with batch processing
Snapdragon Chemistry's VIEW of Flow Chemistry
- Widely applicable across the entire drug discovery >> development >> manufacturing value chain
- Essential for creating medicinally important compounds that are inaccessible in batch
- Proactive integration of flow chemistry in exploratory process development enables much larger downstream efficiencies
In order to deliver exceptional value, we have assembled a network of forefront thinkers in continuous flow chemistry who focus on delivering the best to our clients. We combine our substantial portfolio of proprietary reactor designs and processes with our expertise and capabilities, to be a true thought partner in customizing strategies and solutions that work best for our clients’ objectives. In order to solve our clients’ toughest problems, we also consistently strive to hire the best thinkers and innovators in the field.
10+ years iN client service excellence
Our leadership team has 10+ years of experience at leading professional service firms.
Snapdragon creates detailed proposals and plans, including reactor designs, to provide transparency to our clients on how we plan to accomplish their objectives. Our leadership provides regular communications and updates regarding a project's progress.
DEEP SCIENTIFIC EXPERTISE
Throughout the entire engagement, our clients work with top talent in continuous flow technology and have access to our preeminent leadership — many of whom have led key advances in continuous flow.
We take a flexible approach to working with our clients to ensure that we bring maximal value to our clients' chemistry.
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For additional resources, see the white papers developed based on the International Symposium on Continuous Manufacturing of Pharmaceuticals in May 2014, sponsored by MIT and CMAC.