While most of today’s pharmaceutical production is designed around medicines that help large numbers of patients, innovations in the drug and medical device industries are leading to more precise treatments. New therapies are being developed that are specific to small groups of patients or even a single patient. Precision medicine—sometimes referred to as personalized medicine—is based on the idea that each of us is different and may not react the same way to a particular treatment.
This approach to healthcare uses information about the genetics, environment, and lifestyle of an individual or small group of patients to determine appropriate prevention and treatment, according to the Precision Medicine Initiative. It augments the healthcare options already provided by the traditional one-size-fits-all approach to drug making.
These targeted treatments require a batch of medicine made specifically for those patients who, based on genetic testing, are deemed good candidates. The products are most often aseptically produced injectables that must be temperature-controlled and monitored throughout manufacturing and distribution and, thus, can be very expensive. Oncology products account for 90% of precision medicines.
Diagnostics are essential for the delivery of precision medicine
Diagnostic testing for genetic abnormalities that can lead to disease is the necessary starting point of precision medicine. Testing affects decisions on how products are made, what products are made, and what precursors are needed to make them. As the industry changes its approach to create treatments for individual patients as well as large groups, the need for laboratory testing facilities with advanced equipment and the need for diagnostic consumables will increase. The ongoing need for infectious disease diagnostics—for such illnesses as seasonal flu and COVID-19—has only added to this burden.
The growth of precision medicine has also allowed for the expansion from the more generic uses of genetic tests. There is an entire industry associated with home-based genetic kits that initially provided data about cultural heritage but are now being used to identify potential genetic diseases, allergies, and the propensity to develop one of many types of cancers. Fortunately, these tests are continually improving in quality, rapidity of results, and reduced cost.
Flexibility is the new reality for facility design
Innovations in precision medicine require flexibility in the design and function of facilities that make diagnostics and run laboratory tests. To control the costs and meet the schedules of these manufacturing changes, a clear approach that keeps this flexibility in mind is needed. Facilities must be able to adapt across manufacturing plans and expectations from patients and clinics, while insurance is pushing for lower per-unit costs. Is your facility flexible enough to meet schedules and costs to win the contracts that your business wants?
It is no exaggeration to refer to the manufacture of diagnostics as a mission-critical function of the medical device facilities that make them. Without these tests, patients and healthcare providers cannot know how to best treat a patient. And, with the number and type of diagnostics continually increasing, manufacturers need to be able to pivot quickly. It is important to plan for facilities that can adapt to innovations and meet novel production capacity at a controlled cost.
Consider a manufacturer that is forced to develop a new test quickly. One day it is making a test for influenza and the next it needs to produce a diagnostic for a different virus. The gross floor footage needed to manufacture standard flu tests can be accurately defined nationwide or globally, but that number could balloon exponentially, as it did when COVID-19 hit. The ability to rapidly modify lab and production space becomes critical to increase throughput for the timely production of sufficient numbers of diagnostic kits and testing capacity. This translates as a need for higher quality products, a supply chain that can support logistics, staging, and production of the testing kits, and the analytical testing equipment and lab space to perform the tests.
Adapting for future needs
This brings us to the necessity of operational flexibility. It would be expensive for a carpenter to have a separate hammer for each kind of nail; the idea is to have one hammer that works with as many nails as possible. Likewise, dedicated production equipment is costly, requires its own space for storage and spare parts, and when idle is only collecting dust. Having equipment that can be adapted for multiple processes or products allows for increased uptime and output.
Precision medicine facilities look like laboratories but incorporate significant and complex production equipment. To provide the needed therapies to patients, thoughtful planning for the design, construction, operation, and expansion is necessary to control the overall costs and schedule of delivery of personalized therapies. To protect the lifespan of the facility, a flexible masterplan for scale-out and production is an important step in the overall conception of the project.
Design must take into account the products and capacity currently in the pipeline while making room for multiple products or increased capacity in the future. A rigorous approach to site planning and facility planning is important to allow for cost-effective business growth. While it is fiscally impractical to account for every conceivable configuration for processing spaces, it is possible to plan for the most common production requirements and the ability to scale up in the future. A holistic approach to facility design should be taken into account for processes, personnel, utilities, and amenities. Adequate footprints, appropriate shelled spaces, dedicated equipment spaces, and future flows of personnel, product, and waste allow for future expansion and minimal impact on existing production.
The future of precision medicine diagnostics requires facilities that are designed to adapt so that if a process needs a new piece of equipment, it can be economical to substitute it into the production space. For example, a client may have a specific need from the beginning of the design process to produce 100 million diagnostic vials using a dedicated piece of equipment. Later, they may need to adapt the production space to produce swabs or pin-prick collection kits instead. These changes can lead to equipment or equipment parts being swapped as needed.
Mostly, production spaces are designed around similar cleanliness requirements, but process equipment utility requirements will often vary: one day it could be compressed gas, the next day power, then vacuum or exhaust. Utilities like these should be able to be switched for another at a moment’s notice and with minimal or, ideally, no interruption of the processing space. This plug-and-play configuration of processing equipment within one facility is a cost-effective way to adapt to whatever piece of equipment is needed.
The focus on flexibility in the design of both laboratory and manufacturing spaces is today on COVID-19, but adaptation will be required for any new precision medicine diagnostic test that becomes available in the future. This does not mean building separate facilities to make each new diagnostic test kit or process results from a new test. Instead, an efficient approach for scale-up and scale-out is required to plan for future growth, ideally without having to increase the size of a facility or employee headcount. This holistic approach takes some forethought and creativity regarding the design and construction of a facility. The companies that will win contracts in the future are the ones that can mobilize immediately to manufacture products or expand testing exponentially and expeditiously.
An integrated project solution to meet your flexibility challenges
The pharmaceutical industry has done a remarkable job evolving to meet the needs of patients with an ever-growing range of precision medicines. Improved efficiency, increased throughput, and enhanced compliance are leading to decreased healthcare costs for patients. This has been made possible by the adaptability and efficiency of manufacturing facilities and testing labs that are making precision medicine diagnostics. Applying operations enhancements has led to significant improvements in sample throughput during lab testing while freeing up floor space and making room for more employees in bioanalytical laboratory facilities.
Operations improvement (OI) and simulations can be used to expand an existing facility or to change a functional unit to improve workflow, remove bottlenecks, and identify inefficiencies. Modeling and simulations can be run to take the guesswork out of these proposed facility changes. They can test different scenarios in a single unit operation or for an entire manufacturing facility before additional capital costs are incurred. Diagnostic test laboratories can also benefit from this type of planning, which has been shown to accelerate lab test processing.
You want a partner who asks the essential questions about what will be needed to design and build flexible manufacturing and testing facilities. We provide the expertise to control construction costs because we know how to extract data from our clients so that we can understand your process. We use this data to wrap a flexible design around your needs. We work closely with our clients to develop a project execution solution that drives costs down, meets compliance and quality requirements, and ensures flexibility for the future.