Today’s biotech and diagnostic startups face both tougher challenges and bigger opportunities than their predecessors. Funding is tight, regulations are changing quickly, and the pace of innovation can leave all but the nimblest of businesses behind. The good news is that the companies that navigate those challenges could transform healthcare—and, in Thermo Fisher Scientific, they have a partner that can support them each step of the way.
Thermo Fisher Scientific has a clear understanding of the challenges facing biotech companies and developers of diagnostic tests, as well as research and applied market solutions. Many of the company’s leaders know those sectors well from their years working in them, and their close relationships with clients have given them a front-row view of how the challenges facing startups have evolved in recent years.
Melody Savea, general manager of Thermo Fisher Scientific, molecular diagnostics and life science tools original equipment manufacturer (OEM), has spent more than three decades in the biotech industry. Savea said the current set of diagnostic startups face markedly different challenges from their predecessors that launched five to ten years ago.
Access to funding is more difficult than it was for earlier generations of startups that benefited from a relatively straightforward path to market. In the past, entrepreneurs had an idea, secured funding, launched their venture, and then either went to market, were acquired, or sold the technology. Today, the harsher funding climate is forcing startups to take a more strategic approach to capital allocation.
Startups in the biotech-diagnostic industry are managing those financial pressures while racing to keep up with the fast pace of regulatory and technological changes. The regulatory environment has evolved rapidly, particularly in the wake of the COVID-19 pandemic, and the constant influx of new technologies is creating challenges for startups trying to bring their concepts to market.
The pace of change is particularly fast in the point-of-care testing space. The COVID-19 pandemic spurred a surge in interest in moving testing to the point of care. Seeking to accelerate diagnosis and thereby slow the spread of the virus, startups leveraged technological advances, such as the miniaturization of electronics and improved instrumentation, to develop smaller, more accurate point-of-care tests.
Moving COVID-19 testing to the point of care validated emerging technology and showcased its benefits over traditional laboratory testing. Point-of-care diagnostics provide faster results than traditional tests, which require samples to be sent to centralized laboratories for processing. Accelerating diagnosis can improve clinical and economic outcomes compared to laboratory testing.
Physicians have recognized such benefits for decades, but technical challenges have slowed the transition from testing to the point of care. Notably, reagents, tests, and samples are exposed to different conditions at the point of care, meaning that products must be accurate and reliable at room temperature.
Investing in point-of-care technology
Thermo Fisher Scientific has a long history of supporting developers of diagnostics that use the reverse-transcription quantitative real-time polymerase chain reaction (RT-qPCR), an approach that enables highly specific and sensitive molecular testing at the point of care. As COVID-19 changed the point-of-care testing landscape, Thermo Fisher Scientific stepped up its assistance for the sector by investing in the creation of a broad set of enzymes.
The investment has reinforced Thermo Fisher Scientific’s leadership position in PCR and established the company at the forefront of isothermal amplification—a molecular-biology technique that eliminates the need for the thermal-cycling equipment utilized in traditional PCR. Isothermal amplification is faster than PCR, typically taking 30 minutes rather than 90 minutes, and provides immediate visualization of DNA synthesis.
Researchers have developed various isothermal-amplification methods, each with different strengths and weaknesses, leading Thermo Fisher Scientific to add a wide range of enzymes to its portfolio. Thermo Fisher Scientific can support developers of diagnostics that use isothermal-amplification methods such as whole-genome amplification (WGA), loop-mediated isothermal amplification (LAMP), rolling-circle amplification (RCA), and recombinase polymerase amplification (RPA).
The company has established a well-resourced research and development (R&D) program to drive the rapid, ongoing expansion of its portfolio. The investments have equipped Thermo Fisher Scientific to support lyophilization and air-drying techniques that are key enablers of point-of-care testing. Both processes remove water to eliminate the need for cold-chain storage and extend the product’s shelf life at ambient temperature.
Lyophilization, which involves freezing a product, is the more-established approach but the cost—either of investing in internal capabilities or outsourcing the activity—is driving interest in alternatives. Air drying can serve that need because it has lower equipment and energy costs than lyophilization. Thermo Fisher Scientific sells lyo-ready enzymes (Fig. 1) and is developing air-dryable reagents, positioning it to support both methods of improving stability.
Fig. 1 | Lyo-ready enzymes for molecular diagnostics. These have a glycerol-free format and are compatible with lyophilization.
As well as enabling testing at the point of care, lyophilization and air drying can help companies meet their sustainability goals. Thermo Fisher Scientific is aiming to reduce its carbon footprint by 2030 and to achieve carbon neutrality by 2050 as part of its push to solve complex manufacturing challenges while improving sustainability, reducing emissions, and minimizing the environmental impact of all its sites.
Lyophilization and air drying facilitate the sustainability drive because they simultaneously improve the shelf-life of diagnostic products and eliminate the need for cold-chain logistics—the latter of which use more energy and emit more carbon dioxide than ambient-temperature distribution. As such, moving to lyophilized and air-dried products stands to significantly impact sustainability goals.
Providing holistic solutions
Thermo Fisher Scientific’s work on lyophilization and air drying illustrates how the company is more than just a global leader in the supply of existing enzymes. The company is also facilitating breakthroughs in the sectors it supports, including by innovating novel enzymes and harnessing them to advance broader goals such as the shift to point-of-care testing and development of more sustainable practices.
With its industry-leading portfolio of OEM and custom commercial-supply solutions (Fig. 2), Thermo Fisher Scientific helps customers accelerate programs and bring innovations to market faster, more easily, and with greater peace of mind. Its offering is built on exceptional quality, secure global supply, and time-tested expertise that supports comprehensive, end-to-end manufacturing workflows.
Thermo Fisher Scientific’s involvement extends beyond the products it sells. The company provides personalized attention and support throughout the journey to the market, helping customers as they move through discovery, R&D, clinical trials, and ultimately into commercial production.
The journey to commercialization begins with sourcing custom raw materials and products. As customers advance along the path to market, experienced Thermo Fisher Scientific representatives with technology and market expertise evaluate the workflow needs and help select products from an extensive portfolio.
Fig. 2 | Original equipment manufacturer (OEM) and commercial-supply solutions. Thermo Fisher Scientific offers partnership opportunities for the commercialization of life science products.
If needed, the company can help with custom assay design, workflow optimization, verification testing, stability studies, bulk orders, formulation, and more, as well as handling kitting, custom packaging, private labeling, and global distribution. All the work is done to global regulatory standards such as current good manufacturing practice (cGMP)/quality system regulation (QSR), International Organization for Standards (ISO) 9001 and ISO 13485, and more.
What differentiates Thermo Fisher Scientific?
The combination of custom-assay design and global infrastructure points to what differentiates Thermo Fisher Scientific. The company pairs the scalability and quality that only the largest suppliers can offer with a flexibility that allows it to tailor its services to the needs of all customers, from virtual startups up to multinational corporations.
Scalability and quality
Thermo Fisher Scientific has the scale to provide supply security and simplify operations to reduce costs and improve efficiency. With its large, global footprint, the company has the capacity and capability to reliably meet demand for its products.
The footprint equips Thermo Fisher Scientific to increase its output to meet the changing needs of its customers. As a raw-material supplier, the company can support customers through development and seamlessly step-up production as they bring their products to market and start requiring larger volumes of enzymes and other materials.
Whatever the scale, Thermo Fisher Scientific provides consistent, high-quality products that adhere to regulatory standards. The company has the quality-management system and manufacturing standards to consistently comply with changing regulations and reliably deliver the materials that customers need.
A tailored service
Thermo Fisher Scientific is a large organization that understands and adapts to the needs of the smaller, developing companies that make up most of its customer base. The company tailors its products and services to the specific needs of each customer and evolves its offering as its partners grow and change.
More broadly, Thermo Fisher Scientific listens and responds to customer feedback, leading it to simplify processes to make it easier for smaller companies to access its products and services. Savea knows it is also important for Thermo Fisher Scientific to work with different-sized companies and has embarked on a push to shape the global organization to meet the needs of all customers, wherever they are on their growth journeys.
The changes are helping more diagnostic-assay developers to work with Thermo Fisher Scientific’s experts to advance programs. Customers benefit from a set of holistic solutions, including custom formulation and other activities, that is designed to help smaller companies achieve their R&D goals and ultimately grow their businesses.
Expediting breakthrough diagnostics
Thermo Fisher Scientific’s forward-thinking investments have cemented its status as a partner of choice in raw materials and diagnostic development. By reinvesting profits into its own R&D, the company has established itself at the leading age of the development of technologies to move testing to the point of care and improve the sustainability of supply chains.
All companies of all sizes can benefit from Thermo Fisher Scientific’s investments. A commitment to understanding and adapting to the needs of the startups that are driving innovation in the diagnostic space ensures that Thermo Fisher Scientific aligns with its customer’s processes, helping them to evolve. The actions have cleared the way for effective, innovative collaborations—and ultimately for the development of breakthrough diagnostics that help improve health outcomes.