Implementing continuous bioprocessing in early development will allow companies, and the industry, to truly adopt Continuous Bioprocessing. Together, our platform processes, the 4D Sandbox and our customer focused services will advance the industry toward the successful implementation of continuous biomanufacturing.
Continuous Bioprocessing
Continuous bioprocessing has the potential to improve drug quality and increase patient access and safety. As the next generation of innovator drugs and biosimilars move into early clinical testing, the need for speed to clinic is clear. More and more drugs are receiving fast track approvals, shortening the time between the clinical phases. In continuous manufacturing, there is no need to scaling up a process and therefore no scale up risk—the process runs longer to produce more product.
This speed of production could also help address drug shortages and yes, pandemics and ease supply bottlenecks with more drug produced per unit time. Other benefits include manufacturing “drugs on demand” in compact, cost effective facilities around the world and promote multiple locations closer to patient need, which may be especially relevant in instances of new pandemics or emergencies.
Operational Strategy
4th Dimension will offer automated, single use, continuous manufacturing platforms for Monoclonal antibodies, viral vectors, recombinant proteins and possibly other modalities all built on production line thinking from the ground up. These production lines will provide access to continuous bioprocessing for virtual and emerging companies and add outsourcing flexibility to large Biopharma’s manufacturing networks.
This idea builds on the idea of “just in time” processes, which have already transformed many manufacturing processes but have yet to be fully exploited in drug manufacturing to date. Continuous manufacturing has the ability to deliver higher quality, on demand capacity for the changing needs of Biopharma.
Using this production line strategy, it is possible to add capacity easily by adding complete mirror image lines to the production floor. In this way, operators can move in the ballroom environment and monitor the processes of two lines.
Facility scale out — not scale up.
Using our 4D platform production line strategy, it is possible to add capacity easily by adding production time
to an existing process. Continuous manufacturing has the ability to deliver in an unpredictable world.
Business benefits
Our service-based business model offers outsourced continuous capacity to drug companies by providing processes that are much more compact than traditional processes and can be easily scaled. The 4D automated and streamlined processes based on continuous production lines rather than batch-based processes lead to reduced materials and cost, reduced water usage, increased production per manufacturing footprint and 24/7 operation that can be flexibly deployed to meet demand.
Our continuous manufacturing platforms will:
- Decrease time to market and time to clinic
- Provide flexibility, production on demand
- Decrease scale up risks
- Lower capital expenditures during early drug development
- Improve control of product quality via automation & monitoring with the potential for real time product release
- Provide a blueprint for compact, sustainable manufacturing capacity
Get In Touch
Find out more about our operational strategies for continuous bioprocessing and details on its business benefits by contacting us below:
