To ensure patient access to consistently high-quality biotech therapies, the Center for Biological Evaluation and Research (CBER) sponsored a workshop on opportunities for collaboration with industry and other stakeholders in October of 2004 under the FDA's "Critical Path" initiative. Through this collaborative approach, CBER officials emphasize and encourage the value of discussing critical manufacturing issues with sponsors early in the clinical-development process, especially for companies considering novel methods for scale-up, product sampling, manufacturing-process control, or compliance with current good manufacturing practices (cGMPs).
To remain a contender in the highly competitive field of biopharm development, CBER's message is clear: plan early and often. On the design side, form must follow function to remain profitable. Form must be consistently fluid in laboratory biotech development as function evolves throughout product development and production.
Design should be driven by the present operation, equipment, and infrastructure. At the same time, the laboratory owner must try to identify trends and design to accommodate processes for the future. The following are some best practices that planners at HDR, Inc. have found to help keep labs in the game.
The nature of the research will typically dictate the lab functions, whether chemistry, biology, or both. Providing a modular design is the most cost-effective design practice at this stage to allow future lab conversions and/or expansions.
Adding to the design complexity, lines often become blurred between research, development, pilot and manufacturing labs. While processes at each stage may be similar, the protocols involved are different, and typically are less stringent in the early stages.
Experts recommend beginning with research-quality design, and to incorporate protocols as early in the process as possible. As research advances and moves into the development stage, the facility is prepared to incorporate all required equipment and support systems.
At this stage, it is recommended to tailor the design of the space to a particular project to gain efficiency. A development laboratory's objectives are defined more closely, and it may perform small-scale manufacturing; therefore, it must meet higher regulatory criteria than a research lab. However, this stage continues to be highly volatile. If a potential product is considered ineffective or not feasible in development, the lab's next project can be extremely different from the current one, and the lab must be rapidly adaptable for the next project.
It is best to build in sufficient flexibility to permit a change-out of equipment and space for infrastructure that supports the new systems. Designs should include: