Designing laboratories for specialist capabilities

How do you design laboratories that can accommodate capabilities you don’t yet know you’ll need? As pharmaceutical pipelines diversify, that question is becoming central to lab planning

Philip Bradley at Astoriom

Specialist environmental testing, including thermal cycling and photostability studies, illustrates how changing requirements are influencing decisions around lab infrastructure, flexibility and long-term planning.

Pharma labs are supporting a broader range of products and development programmes than they were even a decade ago. Lab teams are designing new facilities around increasingly varied analytical techniques, environmental studies and stability programmes, while recognising that additional technologies and testing requirements are likely to emerge over the operational life of the lab. Product pipelines rarely remain static over that period. Facilities commissioned today may support pharmaceuticals, biologics, combination products or diagnostic technologies, which may introduce different analytical and environmental testing requirements in the years to come.

Decisions made during lab planning determine the infrastructure, engineering services and quality systems that will support a facility throughout its operational life. Increasingly, those decisions are centred on capability rather than equipment. Introducing a specialist capability establishes an ongoing requirement for qualification, preventive maintenance, calibration, engineering support, operator training and quality documentation alongside the costs of the equipment itself.1 These maintenance, qualification and validation activities become part of routine lab operations for as long as the capability is maintained, influencing engineering resource, staffing, utilities and operational planning. Collectively, these activities define the operational life cycle of that capability, from installation and qualification through to long-term maintenance, quality oversight and routine use.

Specialist environmental testing illustrates these planning decisions particularly well. Capabilities such as thermal cycling and photostability studies can be technically important without forming part of routine lab activity.2

Some development programmes depend on them extensively, while others require them only at specific stages or for individual regulatory studies. Expected utilisation is, therefore, an important consideration during lab planning. A capability used routinely places different demands on lab infrastructure from one required only occasionally, even where both are scientifically important.

Specialist capabilities also place practical demands on lab infrastructure that are easy to underestimate during the planning stage. Environmental chambers, for example, can require significant floor space, electrical capacity, cooling provision, maintenance access and planned servicing throughout their operational use. Decisions made during the design stage can determine whether future capabilities can be accommodated through planned expansion or require more extensive engineering modifications later. These requirements influence lab layouts, engineering services and future expansion and should be considered during the earliest stages of facility design.

Thermal cycling is one example of a specialist capability that has become increasingly relevant as pharma supply chains have grown more complex. Products may experience repeated temperature fluctuations during international transport, customs delays, local distribution or temporary storage before reaching the end user.3 Understanding how those conditions influence product performance has become an important part of development for many pharmaceutical and diagnostic products. Thermal cycling studies recreate these environmental changes under controlled conditions, allowing organisations to assess how products respond to repeated transitions between defined temperature set points and generate early evidence of their response to transport-related temperature excursions as part of wider stability testing programmes.

In one example study, a diagnostics manufacturer needed to evaluate how its test kits would perform following exposure to transport-related temperature extremes before entering long-term shelf-life studies. The protocol required samples to follow a defined sequence of temperatures ranging from -10°C to 50°C over 128 hours, replicating the types of excursions that could occur during international distribution. The study involved control of both the target temperatures and the transition between them so that the complete transport profile could be reproduced consistently.

Earlier studies had relied on transferring samples manually between separate stability storage environments at defined intervals. Samples were moved between chambers operating at different temperatures to recreate the required profile. Although this approach achieved exposure to the target temperatures, each transfer introduced a period outside the controlled environment and environmental records reflected the performance of individual chambers rather than one continuous programme. For transport simulation studies, where the sequence of temperature changes forms part of the protocol, this distinction becomes important because the transition between set points contributes to the environmental conditions experienced by the product.

A dedicated thermal cycling cabinet within an off-site storage facility allowed the complete programme to be delivered within a single validated environment. Heating rates, cooling rates, dwell times and the sequence of temperature transitions were programmed into the chamber so that the full profile could be reproduced consistently. Before introducing customer samples, the technical team ran the intended protocol to confirm that the chamber could achieve the required conditions throughout the 128-hour cycle. Continuous monitoring generated a complete temperature trace covering the entire study, providing documentary evidence of the environmental conditions experienced by the samples.

Chamber capacity also influences study design. Completing an entire programme within a single validated chamber allows one continuous environmental profile to be maintained throughout the study. Dividing samples between multiple chambers or transferring them manually between environments adds handling, coordination and documentation to the programme. Capacity, therefore, influences operational planning as well as technical delivery.

For lab planners, the question is how requirements of this kind should be accommodated within the operating model, including whether anticipated demand warrants permanent in-house capability or access to established external infrastructure. Similar planning considerations apply to photostability studies and other specialist environmental testing. Although the scientific objectives differ, questions around utilisation, infrastructure, quality systems and operational resource remain remarkably consistent.

Supporting this type of capability within a pharma lab requires careful cost considerations that extend beyond the installation of specialist equipment. Thermal cycling establishes an ongoing requirement for qualification, calibration, preventive maintenance, engineering support and quality oversight throughout the lifetime of the chamber. Organisations also need access to the technical expertise required to maintain and service the equipment, whether through internal engineering teams or external maintenance and service contracts. Standard operating procedures need to be developed, operators trained and documentation maintained to support routine use. These activities continue regardless of whether the chamber is used every week or only for occasional development studies.

Alongside the capital expenditure, quality management activities, energy consumption, servicing and periodic revalidation contribute to the total cost of maintaining the capability throughout the lifetime of the equipment.

Decisions about specialist capability can arise in different ways depending on the stage of a lab life cycle. During the design of a new facility, they influence infrastructure planning, utilities and the allocation of engineering resource from the outset. In established labs, these decisions often arise incrementally as development programmes evolve, with existing space, engineering services and validated workflows constraining how readily teams can introduce additional capability. What appears to be an equipment decision can, therefore, become a broader operational exercise.

When additional capacity or specialist capability is required, organisations need to consider whether expanding in-house lab capacity represents the most appropriate use of space, capital and technical resource or whether that requirement can be met through qualified external infrastructure. The decision also has implications for the longer-term use of lab space, particularly where specialist equipment requires a permanent footprint but is only used intermittently. Where a capability is dependent on a single piece of specialist equipment, contingency arrangements for maintenance or equipment failure also form part of the infrastructure decision.

The economics can differ significantly where demand is intermittent. In one illustrative comparison for a 1,000l environmental cycling capability, the cost of accessing existing external capability for a specific study was more than 90% lower than the estimated three-year cost of establishing and operating equivalent capability internally.

The internal calculation included equipment purchase, installation, qualification and mapping, utilities and room preparation, followed by energy, maintenance, calibration and requalification over three years (Table 1).

The business case for internal investment becomes stronger as utilisation increases, so anticipated demand over several years is an important part of the calculation. The scale of any saving will depend on utilisation, existing infrastructure and study requirements, but the comparison demonstrates why total cost of ownership provides a more useful basis for expansion decisions than equipment purchase price alone.

When making these considerations, external partners can provide technical expertise during infrastructure planning. Organisations considering additional capacity may draw on their experience to assess requirements and the practical implications of different approaches. Experience of operating specialist infrastructure can provide insight into the engineering, quality and operational requirements that sit behind the initial capital investment.

This can be particularly valuable where requirements are unique, demand is uncertain or the capability sits outside routine internal operations. Early technical consultation can help inform whether permanent in-house capability is justified, provision should be made for future installation, or established external capability offers a more appropriate route.

Where external capability forms part of the operating model, the provider and its infrastructure require appropriate technical and quality assessment. Accessing external infrastructure does not remove the technical requirements associated with specialist capability, but it changes where responsibility for maintaining that capability sits. Organisations, therefore, need to assess the provider’s protocols, validation status, technical support, operator experience, operating procedures and documentation against the regulatory and quality requirements of the study.

Access to established external capability can also reduce the internal resource needed to manage specialist equipment, including qualification, calibration, maintenance and associated service contracts, allowing lab staff to remain focused on core activities, while specialist testing proceeds in parallel.

Good lab design makes provision for different ways of accessing specialist capability over the lifetime of a facility. Some capabilities justify permanent infrastructure because they underpin routine operations. Others may be planned for through reserved utilities, available space or defined workflows, while additional capabilities can be accessed through established specialist facilities as demand arises.

The appropriate approach depends on anticipated utilisation, the facility’s capacity for future expansion, available technical resource, quality requirements and the role that capability plays within the wider development programme. Considering the operational life cycle of specialist capability during lab planning helps create facilities that can adapt as requirements evolve, while ensuring development programmes have access to the infrastructure and expertise needed to safeguard samples and deliver robust scientific studies reliably and effectively.

References: 1. Visit: database.ich.org/sites/default/files/ Q1A%28R2%29%20Guideline.pdf

2. Visit: database.ich.org/sites/default/files/Q1B_Guideline. pdf

3. Visit: eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ: C:2013:343:0001:0014:EN:PDF