Launching a successful start-up and scaling this into a profitable business is challenging, regardless of the sector in question. However, success within the laboratory-based pharmaceutical and biotech industries is exponentially more difficult due to the need to raise substantial capital, move quickly, and follow regulatory requirements..
Venture capital funding in the biotech sector continues to increase despite the challenges, yielding nearly a 50% increase in funded start-ups between 2016 and 2022.1
Continually increasing competition between start-ups and investors’ demands for rapid results means that founders are required to be hyper-vigilant regarding their strategic needs from the start.
The laboratory is considered the engine of any biotech company, responsible for process development, novel discoveries, and even commercial product manufacture.
Failing to establish a productive and functional laboratory in a timely manner represents a key challenge. This means that the design of a new lab and the installation of its equipment must be done correctly to maximize limited capital and develop an environment that can drive innovation, productivity, and, ultimately, success.
This article looks at the major challenges faced by startups when establishing and equipping a new laboratory, providing practical insight and advice on successfully mitigating these challenges. This includes:
- Implementing the business’s strategic needs into the design and equipping of the laboratory.
- Tool selection considerations to ensure the efficient use of capital.
- Avoiding redundant laboratory equipment and being able to pivot.
- Understanding tool selection and the impact of these choices on workflows and productivity during a start-up’s early stages.
Establishing an optimal lab from the onset
Laboratory setups are often expedited at the expense of quality in an environment where time is money and tasks often must be completed with tight timelines.
This focus on generating almost instantaneous results often sees founders that have just closed a successful seed round failing to properly consider the exact needs of their labs.
Product utility and efficacy can be dependent thet ype of therapeutic or test, and specifications can be defining factors in a successful product launch. Careful consideration must be given to the company’s strategic needs and the equipment needed to achieve these goals.
Defining priorities and equipping the lab accordingly
Start-up operations move fast, with each stage’s critical process requirements varying considerably. For instance, early-stage drug discovery start-ups typically prioritize high-throughput processes to rapidly screen as many candidate molecules as possible. The priority may switch to scalability and volumetric output later in the development processes, particularly as market entry nears.
Founders must clearly define and prioritize the critical process requirements required to accommodate their current strategic needs prior to ordering laboratory equipment.
Table 1. Operational parameters to be considered. Source: METTLER TOLEDO Rainin
| Parameter |
Equipment Characterization |
Benefits |
| Speed |
High-throughput or rapid experimental processes require advanced instruments that are usually robotic, automated and expensive |
Useful for expediting discovery science and compound screening, where mass testing is required over precision or scale of output |
Precision/
Accuracy |
Highly precise and accurate tools that enable repeatability and fine-detailed molecular experiments |
For the detailed investigation of biologic components and answering of specific questions |
| Scalability |
Equipment that enables the output of the process (e.g., product volume or data generation) to be increased through modular equipment or
tools with wide volumetric ranges |
Scalability is essential during the progression from preclinical to clinical stages, as the requirement for small scale animal doses ramps up to meet first-in-human doses |
| Volume |
Equipment and tools capable of producing large batches of product for market entry |
Enables the larger batch sizes needed for commercial production runs |
| Compliance |
Tools with built-in quality control
checks and recordkeeping |
Simplify QC and QA to meet regulatory compliance requirements (e.g., during GLP/GMP processes) |
| Ease of use |
For the basic jobs, where ease of use is
more important than complex functions |
Enable tasks to be completed without any advanced training |
The pipette is the workhorse of laboratory processes, providing an excellent use case for how it is possible to achieve critical process parameters through tools with specific properties.
Precision and accuracy
Pipettes that can transfer incredibly low volumes are essential for molecular workflows that require the highest precision and repeatability, such as next-generation sequencing (NGS) and reverse transcription polymerase chain reaction (RT-PCR).
This is combined with the need to dictate minute increments at the highest precision to achieve perfect replicates. Electronic single-channel pipettes in the 0.5 μL to 10 μL range provide the highest standards in these types of applications.
Speed
Implementing multi-channel pipettes can accelerate sample processing when speed is prioritized over precision, achieving this with only a minor compromise in precision and accuracy.
These solutions allow startups to be efficient and rapid in operations where true high-throughput processing is required. For example, the use of intuitive bench-top pipetting systems are able to dispense onto an entire 384-well plate in just a few seconds.
Compliance and ease of use
Conventional manual pipettes offer ease of use with little to no training necessary, but more advanced electronic options and pipette management systems are better able to support GMP/GLP compliance. It is also possible to build these options into a 21 CFR Part 11 Compliant (electronic record keeping) workflow.
It is important to select the right tools for the job, whether a start-up is looking to get a lab up and running as quickly as possible, or it is ready to enter the market and, therefore, requires GLP standards.
Founders should liaise with the lab manager and scientists before establishing the lab, clearly mapping out and prioritizing process requirements for each specific stage of the product development program. Founders should delay purchasing tools for later priorities, instead reserving capital for unanticipated lab purchases.
Being prepared to pivot
Start-ups continue to evolve, with their original product idea often pivoting to another idea. This is especially prevalent within the life sciences industry, where startups are often just one experimental result or scientific discovery away from the need to pivot on their development program.
Candidates in cancer therapeutics are regularly found to be more efficacious against a different cancer type than the initially selected indication, and the repurposing of biologics into entirely unrelated fields is commonplace.
A start-up should always have a “plan B” to provide a critical safety net. A considerable and expensive amount of redundant lab equipment can sit idle if that pivot arises and prompts a significant shift in laboratory processes, seeing the input capital go to waste.
Start-ups can avoid this by not over-equipping, especially in the very early stages when the company is rapidly developing and learning. Founders may be tempted to leverage discounted bulk or multi-item purchasing to equip the facility with everything required for the complete development program, ranging from anywhere from 3 to 10 years or more.
Start-ups should instead utilize capital efficiently by only equipping a laboratory for the operations planned in the upcoming 12 months.
This approach makes start-ups more able to pivot where required, preserving capital until it is required and considerably lowering the risk of wasted resources and redundant lab equipment.
Not equipping for a non-existent workforce
Start-ups may rapidly grow exponentially, or this growth can be a slow process. It is important to forecast team size realistically, purchasing accordingly to avoid wasting resources. Delivery times for equipment orders are currently only a few days, meaning there is no advantage to equipping a lab for a workforce that is not expected to be in place for another two years.
It is advisable to use an on-demand supply chain to efficiently utilize available capital and to allow sufficient time to test and refine products before bulk purchasing.
Exploring the market
Founders regularly rely on brands they have previously worked with when equipping a new lab. This approach often sees them establishing labs that replicate their previous industrial or academic position.
First-hand experience can be extremely useful in selecting the most appropriate tools, but it is important to be sure that these products are the best tools for the job and not just the first products that come to mind.
There is significant and widespread innovation throughout the life science sector, with an increasing number of processes and equipment becoming automated, and long-established tools becoming redundant within a matter of years.
Therefore, it is essential to thoroughly explore the market and engage with a range of vendors and colleagues throughout the field to select the most suitable and current product for a start-up’s specific experimental needs.
The false economy of low-cost lab equipment
Resources and capital are limiting factors at each stage of the start-up pathway, whether closing initial seed funding or during later series rounds. The leading cause of start-up failure continues to be running out of funds, with many start-ups seeking to avoid this limitation through the purchase of low-cost and unsuitable lab equipment.
These shortcuts typically result in long-term negative consequences, including failed time-to-market goals and increased expenditure.
Equipping a new laboratory with the least expensive available tools and equipment can be a viable means of stretching capital as far as possible, such as during the prioritization of operational parameters.
For example, leveraging manual pipettes over electronic counterparts for simple, unregulated processes. Founders should focus more on choosing the most suitable tool for the job, however, rather than simply selecting the cheapest.
The primary downside of this approach becomes evident when equipment quality is sacrificed for cost savings. It may be possible to achieve immediate savings in the short term but often results in larger expenditures over the long term as low-quality tools fail and must be replaced.
As well as the impact of low-quality tools on start-up finances, the operators that use them are also affected. Start-ups are well known for their long working hours, and subjecting workers to suboptimal tools can adversely affect output, performance, and work culture.
Minimizing disruption and meeting time-to-market goals
Disruptions in product development can have devastating consequences in terms of a start-up’s time-to-market goals and its overall success. For example, investigational new drugs placed on clinical hold during first-in-human testing can prolong the time required and increase the cost associated with drug development. These disruptions may discourage investors, potentially shutting down the entire development program.
Start-ups must minimize workflow disruptions and keep the market entry schedule on track to ensure success. It is, therefore, important to consider a number of important factors to prevent failed experiments, as well as reducing the time and cost required to get a new product to market.
Considering the micro steps
Troubleshooting typically begins with the major processes when workflows go wrong, with large equipment pieces calibrated, reagents replaced, and new cell lines established. Little thought is given to the minor procedures, though these still play a significant role in the overall experiment.
This need to consider minor procedures is especially evident with the pipette, which may seem like an unimportant laboratory tool, but is perhaps the only piece of equipment used throughout the entire workflow.
A pipette’s utility underpins everything from reagent preparation to cell culture work, and dosing in humans.2 The use of low quality pipettes prone to over- or under-dispensing can have a profound and long-lasting impact throughout the workflow.
These issues only become evident when analyzing the end result, but it is exceptionally challenging to pinpoint the disruption to an earlier step once the process has reached its end.
Liquid handling errors typically arise from two common causes.
Image Credit: METTLER TOLEDO Rainin
Low-quality pipettes typically lack the accuracy and precision over extended use to ensure replicability between repeat experiments or batches. It is possible to avoid this issue by using reputable, high-quality brands offering reliable warranties and customer service. Pipette performance can be improved further by operating the pipette close to its nominal volume, with accuracy, systematic error, and random error performance metrics shown to be significantly improved when the pipette delivers volumes close to its 100% nominal volume.
Out-of-calibration pipettes can also cause workflow disruption. This common issue arises from minor damage, such as dropping a pipette, or heavy use. Regular preventative maintenance and calibration of pipettes can ensure smoothly running workflows as well as significantly reduced costs, risks, and liabilities linked to failed experiments.
It is now easier than ever to avoid calibration issues thanks to innovative electronic pipettes and pipette management tools. These advanced tools can detect problems before these adversely affect processes, ensuring that all pipettes are appropriately calibrated and maintained and performing appropriately, as well as ensuring that records and certificates are well organized and accurate.
Pipette performance should also be routinely verified in order to ensure dispensing performance and correct aspirating. Pipette verification was historically performed using a burdensome gravimetric protocol necessitating triplicate measurements and manual calculations, but the introduction of newly available innovative pipette verification equipment now allows pipette performance to be verified in just 60 seconds. This ease of verification enables more regular verification amongst users, reducing workflow disruptions and improving compliance.
These factors highlight the importance of considering the minor components of complex experiments. It is possible to maintain problem-free workflows by employing trusted, high-quality tools that are regularly calibrated to prevent disruptions and keep workflows running.
Increasing productivity via ergonomics
As well as being functional in their use, laboratory tools must also be ergonomic for the operator. Equipment that is difficult to use or uncomfortable diminishes productivity because users will require additional breaks or may avoid using the tool altogether.
Poor ergonomics can also lead to repetitive stress injuries, potentially taking employees out of work. This reduction in workforce can have major implications on small teams’ productivity and schedules.
Pipetting has been reported as posing the most significant risk of repetitive stress injuries within life science workloads,3 meaning that this should be the main focus for the implementation of ergonomic solutions.
Solutions to this issue can be quick and easy to implement; for instance, the use of Rainin LiteTouch™ System (LTS™) pipettes and tips able to reduce tip ejection forces by up to 85%. This represents a major improvement considering that conventional tip ejector forces may exceed 4 kg of force. LTS allows researchers to maintain a better bench posture by requiring less force to load and eject pipette tips, ultimately increasing productivity at the bench.
Remaining compliant
Regulatory issues are a leading cause of delays in the market. Regulated entities must demonstrate their compliance through traceability and data integrity, whether this is GLP, GMP, or GCP. Achieving and maintaining compliance represents a significant hurdle for start-ups, most notably for founders with backgrounds in academia and other less regulated sectors.
Requirements for compliance include the performance and documentation of routinely scheduled service maintenance, calibration, and training on equipment employed in the laboratory workflow. Failure in any of these aspects can potentially add considerable delay and expense to the development program.
Start-ups are advised to expend considerable effort in order to avoid regulatory issues, including focusing on all regulated processes irrespective of how minor these may appear. Compliance is becoming more straightforward, with innovative lab equipment able to record usage and calibration status, providing founders with a compliant electronic audit trail. Implementing electronic lab equipment and management software, from pipettes to pH meters and spectrophotometers, into a new lab makes traceability and compliance easier than ever.
Conclusions and recommendations
Succeeding in the exceptionally competitive biotech start-up field is already challenging, without the added risk of working with suboptimal lab equipment and tools. It is important to carefully consider lab equipment and ensure the correct tools are implemented at the right time to maximize capital and facilitate business development.
Working with trusted and reputable suppliers known for robust customer and calibration services designed to maintain equipment over many years is advisable.
Start-ups should take advantage of opportunities to test equipment prior to purchase to determine whether it meets process requirements and the team's ergonomics.
Failure to make the most of these opportunities can drastically delay and disrupt time-to-market. Implementing “quality by design” processes from the start can help avoid workflow disruptions by developing compliant processes with the right high-quality tools, even in seemingly minor processes.
Careful consideration and appropriately equipping a new lab can be key to meeting time-to-market goals, keeping development programs running, and ultimately assuring start-up success.
References and further reading
- Next-generation platform technologies are driving the biotech VC surge | McKinsey [Internet]. [cited 2022 Oct 28]. Available from: https://www.mckinsey.com/industries/life-sciences/our-insights/what- are-the-biotech-investment-themes-that-will-shape-the-industry
- Killingley, B., et al. (2022). Safety, tolerability and viral kinetics during SARS-CoV-2 human challenge in young adults. Nature Medicine. (online) https://doi.org/10.1038/s41591-022-01780-9.
- Ahram T, Jang R. (2018). Advances in Physical Ergonomics and Human Factors: Part I. AHFE International. (online) https://doi.org/10.54941/1001.
Acknowledgments
Produced from materials originally authored by Dan Sheridan, BCs., MSc. from Colabb on behalf of Mettler Toledo.
About METTLER TOLEDO Rainin
Life scientists around the world rely on high-quality liquid handling equipment from Rainin. Our premium instruments and consumables reflect our passion for exceptional quality and innovative design. They are built to deliver years of accurate, reliable and ergonomic operation. Pipetting 360+ reflects our commitment to providing the very finest in pipettes, pipette tips, service and support.
Sponsored Content Policy: News-Medical.net publishes articles and related content that may be derived from sources where we have existing commercial relationships, provided such content adds value to the core editorial ethos of News-Medical.Net which is to educate and inform site visitors interested in medical research, science, medical devices and treatments.