‘Network’ filling strategies for large biopharma
Implementing a cohesive manufacturing strategy across a global company is like steering a cruise ship. What if a ‘network’ strategy for aseptic filling could make it corner and accelerate?
When you have sites distributed around the world, getting them to coordinate is a huge challenge.
Different capabilities, regulations and talent pools complicate a situation that’s already hard to manage. As a leader in manufacturing, you see the evidence—slow tech transfer processes, and quality problems at some sites, but not others. Production processes cannot be easily transferred or replicated at different sites.
The crucial difference between the sites is the technology they are using. How do sites talk to each other if their filling machines are entirely different?
Scale out with standardized technologies
Companies including Roche / Genentech and WuXi Biologics have realized it does not have to be this way. They embarked on ‘network’ strategies where sites use standardized technologies to scale out manufacturing capacity.
Roche / Genentech has presented this idea at ISPE and PDA events over the past couple of years. As they crafted a manufacturing plan for their current pipeline, it made sense to use standardized technologies in development, then scale out by adding more of the same machines. The company’s decision-making is driven by “moonshot goals” that include reducing the cycle from molecule to medicine to three years, and achieving a 10x reduction in the cost of goods for their drug products.
Roche / Genentech’s network strategies go beyond filling into bioprocessing and secondary packaging equipment. The SA25 Aseptic Filling Workcell was selected as the global flexible filling platform based on short lead times, low capital expenses, versatility in handling different container formats, and standalone utility requirements.
Network strategy using Aseptic Filling Workcells
The approach of scaling out through standardization is common in other industries. Vanrx uses the term workcell for its machines because of semiconductor workcells. Semiconductor companies do not make a faster machine to make more chips, they add more of the same machines.
WuXi Biologics, the global CDMO, took a similar path. They started with one SA25 and are now expanding that footprint to multiple machines at multiple sites. Scaling out allows them to add capacity faster for their global customer base. Their first machine reached its first GMP batch release in 15 months from purchase order, with 7 container formats validated.
With multiple SA25s in place, the sites will be highly agile in providing filling services to different clients. We talk about how standardizing the aseptic process within closed robotic systems reduces production risks in another blog.
Cut tech transfer times and create repeatable production processes
In public presentations, Vanrx’s customers pursuing network strategies shared the benefits of building networked manufacturing.
One of the common themes was reducing technology transfer timelines. The thinking goes that if the filling process is standardized across machines, then scaling out cuts down transfer times. Your company builds up institutional knowledge of how to use a filling platform across sites and can work together on process improvements, recipe development, etc. And if a site needs a filling machine, the sourcing, construction and installation times are cut down. The site is handed a standard implementation binder, and off they go! Customers can be GMP ready in 12 months from their purchase order if they move fast.
The connecting thought is that a closed robotic system relies more on software programming than conventional filling machines. The robotic system is fully integrated by one company, whereas many conventional filling systems combine filling machinery from one company and a barrier system from another (or from two divisions within the same company). Standardization around an integrated platform means that you have a fleet of machines that can undergo software improvements to add functionality and squash errors.
It’s a long journey to decide on a network filling strategy. If you would like some materials for your business case, get in touch with Vanrx and we’ll help you out.