The concept is simple, chemical reactions create diversity, but chemical mixtures need purifying into their components, and their constituents fully analyzed and tested, before they can be considered as drug molecules or used towards targets of therapeutic benefit.
Pre-packed plug and play purification cartridges were developed over 30 years ago by Biotage and today still remain one of the most intuitive and reliable methods to purify compounds. The same chemistry principle applied in a lab to purify milligrams of product, can be scaled 10000 fold in a production environment, via a family of cGMP compliant systems, to isolate kilos of the same product.
For years we have tuned our stationary phases and optimized our purification equipment platforms to support scale-up with a minimum of surprise. We love the technology and science but also need it to be repeatable and predictable, after all, our clients prize the output of a purification processes, not just the journey.
For when chemical or drug product output is time critical, in times of fast changing projects, whether it is regional or global, Biotage delivers world class purification solutions with ease of use with plug and play simplicity, all designed to work seamlessly in scale-up purification environments.
Traditionally flash purification was designed out of production processes, due to the lack of understanding and belief that relative costs and time to transfer methods from a small-scale lab environment to production would be too great. Flash purification was historically run in large glass columns using self-packed silica in those production environments but for some, that proved notoriously irreproducible compared to the convenience of pre-packed cartridges which offer the same purification result each time. Pre-packed cartridges can also help with compliance with local health and safety regulation, since operators never need to handle loose silica. For the production of HP-APIs or more potent drug targets (including some small biologics, even anti-viral compounds), less drug is needed so a full-scale chemical production development program is not always necessary, so flash chromatography has grown significantly in popularity over the years, and is currently one of the most intuitive, viable and rapid solutions for purification outputs when timelines are tight. Add the concept to a purification instrument platform that is solidly built, designed for cGMP production environments, and specialized for one job, day-in day-out and without fail, and whose output can be described and tuned precisely by chemical engineering calculations, such as the Biotage Flash 75/150/400 family and you can see why this is one of the most powerful purification and flexible methods for progress when we just have to keep going.
This microsite contains how-to articles and guides to the process of flash purification with a special focus on how flash purification can be used in two of the most important classes of purification carried out today, normal-phase and reversed-phase. We show case studies that we have performed, and results obtained during scale-up which are a very handy template for anyone needing to hit the ground running to rapidly purify mixtures for fast-tracked, or high priority projects. We’ve also created videos which show how simple the process can be and will add some feature rich white papers to provide a comprehensive background to the fundamentals and the principles involved in creating viable scale-up manufacturing processes.
To get started with the fundamentals of scale-up, follow the link below to learn more on how to effectively scale-up flash purification: