In the fast-changing pharmaceutical industry, adaptable planning provides a competitive edge.
Last year's catastrophic flu vaccine shortage and escalating congressional debate over drug safety continue to shine the spotlight on biotech product manufacturing. A constant balance must be achieved between cost-conscious drug development, pressure to meet quality, FDA-approved biotech products, and development of new treatments to meet patient needs, according to Jill Wechsler's "Regulatory Beat" column found in the June 2005 issue of BioPharm International.
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.
Because some products rapidly become blockbusters and others fizzle and are abruptly pulled from the market, pharmaceutical laboratories — whether for research, development, pilot or manufacturing — should be built with flexibility to fluctuate with the current product. Planning for 10 or even five years ahead can leave a laboratory sluggish in its ability to adapt to current market demands.
cGMP pilot facility for the development of a drug delivery system technology.
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:
A manufacturing lab may perform the same or similar duties as a development lab. However, it typically:
Several overreaching best practices hold throughout the life cycle of a lab:
Over- and under-designed laboratories lead to inefficiencies and increased costs. It is important to design for current processes but to also anticipate future needs — and to build in flexibility to adapt quickly to unanticipated circumstances. On the surface, processes may be similar, but protocols actually may be different. Through collaboration, as CBER recommends, and through identifying the protocols early in the process, pharmaceutical laboratories can deliver consistently high-quality products and maintain their competitive edge. Most importantly, form must fluidly follow function in the fast-changing, fiercely competitive biopharmaceutical world.
Mr. Farach is a laboratory/facility planner for HDR, Inc., 8404 Indian Hills Drive, Omaha, NE 68114,Tel: 916. 817.4700, Fax: 916.817.4747, firstname.lastname@example.org Clarence Lind, MBA, AIA, is a project manager for HDR, Inc., 402.399.1345, Clarence.Lind@hdrinc.com