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
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
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
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:
- Modular casework, movable benches, or benches on wheels
- Demountable walls to adjust total area required for projects
- Appropriately sized space and adaptive infrastructure. Design for a basic utility load, but anticipate increased electrical
loads, process gases, and plumbing. Interstitial space is ideal, but may be economically prohibitive. At the minimum, include
higher floor-to-floor space to accommodate adjustments.