Laboratories for industrial, commercial, or clinical manufacturing applications have different objectives than typical academic research laboratories, with workflow efficiency and regulatory compliance essential for smooth operations. Researchers need to carefully balance workflow design and instrumentation needs alongside scaling and expansion plans when setting up their manufacturing operations. A proper initial set-up establishes a firm foundation, and offers much more cost-effectiveness and efficiency compared to constantly re-tooling or tinkering with a process after everything has been put into place.
Starting with the Workflow
Workflow requirements are the primary driving force affecting how a new industrial or commercial laboratory is set up. Biological products, especially ones designed for clinical applications, must adhere to regulatory requirements in terms of quality, consistency, efficacy, and safety. Current Good Manufacturing Practices (cGMP) dictate that the best way to assure product compliance is to implement a workflow that follows cGMP at every step.
Spatial organization can be a big part of becoming cGMP compliant: Will there be enough space for the specific instruments required? Will environmental controls need to be implemented—for the whole facility or just a portion of it? Are there specific conditions that need to be met when transferring the product from one stage of the workflow to the next? Moreover, what is enough for today may not be sufficient for tomorrow. Researchers should strive to build flexibility into their workflows and their facilities so that they can potentially scale-up without rebuilding their workflow or moving shop.
Supporting Enterprising Endeavors
All of this creates a delicate balancing act. Worrying too much about the future can introduce excessive risk (i.e. spending too much capital on an overly large facility) before a venture has established a firm foothold. However, not paying attention to the future can create cost inefficiencies down the line. Fortunately, researchers moving into the commercial or clinical sector do have resources at their disposal. Cytiva’s Enterprise Solutions, for example, packages technology, facilities, and services together to create an end-to-end platform aiming to address the complexities of biomanufacturing.
The FlexFactoryTM platform is a key part of Enterprise Solutions, and is a customizable manufacturing platform for supporting scale-up or scale-out processes. Together with Cytiva experts in process design, researchers can design and configure single-use or hybrid manufacturing platforms for their unique bioprocessing or manufacturing needs that can be up and running in 12 months. FlexFactory platforms can be installed in new or existing facilities, and are designed with regulatory compliance and cGMP in mind. FlexFactory also heavily implements automation for improved efficiency and consistency, and data from each instrument is centralized on a single workstation for real-time monitoring and control.
Cytiva Enterprise Solutions also provide options for researchers without existing facilities. KUBioTM modular facilities reduce costs and project timelines by using prefabricated modules that can be constructed in parallel. A KUBio facility can be ready in as little as 18 months, and the modular nature of KUBio solutions also facilitates easier expansion down the line, especially because FlexFactory platforms are included as a fundamental part of each KUBio. This altogether minimizes researcher risk by not forcing them to expand too fast too quickly, while still retaining the option to expand at a more appropriate time in the future without having to abandon existing workflows and facilities.
As an end-to-end platform Enterprise Solutions further offers comprehensive services and support options for researchers moving into biomanufacturing. This comprehensive offering includes: training and education, process development services, bridge manufacturing, and flexible maintenance support. The initial foray into the commercial sector can be daunting, but awareness of major pitfalls, combined with a well-established expert support network can help smooth the road ahead.
- B. Goldstein, P. Avasthi, “Guide to setting up and managing a lab at a research-intensive institution,” BMC Proc, 15:8, 2021.
- C.L.L. Dahlberg et al., “Building a laboratory at a Primarily Undergraduate Institution (PUI),” BMC Proc, 15:2, 2021.