Monday, September 11, 2017
Transitioning to Continuous Processing in Pharmaceutical Manufacturing
Continuous processing is gaining popularity in pharmaceutical manufacturing. Continuous manufacturing offers many benefits to pharmaceutical producers, from easier scale-up to faster production and more reliable finished products. As brand-name companies such as Novartis move towards continuous processing, many other pharmaceutical manufacturers are considering how to make the switch. But with the benefits of continuous processing come a unique set of challenges that need to be addressed. In this video, we will talk about some unexpected challenges you may face and how to make the transition to continuous processing as seamless as possible.
As you plan the move from batch to continuous processing, keep in mind that some unit processes are more easily converted than others. Continuous tablet coating, for example, is a well-established process and is easily accessible to most pharma companies. Spray drying, twin screw extrusion, and roller compaction are all inherently continuous processes, and granulation can easily be done continuously with commercially-available ConsiGma™ granulators. Adapting these processes first will give you a leg up as you move towards the development of a single continuous process that spans from API to finished drug product.
A major step in adapting your current batch manufacturing to continuous manufacturing will be evaluating whether you can use the same formulation that was developed for batch processing, or if it will need to be adjusted. This will depend on the specifics of your APIs and excipients, as well as the processes involved in your manufacturing.
If you find you need to change your formulation, companies such as Ashland that place a strong emphasis on continuous processing are a great asset for knowledge as well as excipients designed and tested for continuous processing. Ashland offers a range of excipients that are very well suited for continuous processing. For example, Klucel is a binder that allows for controlled release of formulations processed by continuous hot melt extrusion. Aquarius HSP film coatings have been optimized for continuous tablet coating processes. And Benecel is a versatile excipient that can be used as a binder to control release, or for tablet coatings and capsule formulations.
Fully continuous manufacturing requires automated continuous dispensing, meaning that continuous gravimetric feeding and dispensing of each formulation component must be accurate. It can be difficult to continuously feed some excipients, such as lubricants, glidants, flow aids, and disintegrants added in very small amounts, on the order of grams or milligrams per hour, with sufficient precision. To address this problem, Ashland is actively pursuing the development of new excipients with these key functionalities that do not need to be microdosed.
Continuous processing offers many benefits to pharmaceutical manufacturers and is continuing to gain utility and popularity in the industry. In the near future, commercial continuous manufacturing will likely continue to expand to include enabled formulations, parenterals, biologics, and antibiotics. Although switching from batch processing to continuous processing can pose unique challenges for your formulations, working with suppliers and contractors that specialize in continuous processing can ease the burdens of these challenges and make switching to continuous manufacturing easy.