Written by Chris Forsdyke, Head of Laboratory Services, and Elisa Masat, Principal Development Scientist.
Image Credit: Gorodenkoff/Shutterstock.com
When considering assays, routine lab tests often come to mind – boxes to tick, datasets to generate. But assays are more than that. They are the building blocks and architecture that underscore translational research.
Without them, research lacks both structure and validity. With them, it is possible to design programs that are resilient, scalable, and ready to flourish into novel therapeutic domains.
Why assays require early planning
Rather than being add‑ons, assays are the means by which biological processes are converted to data that is meaningful and measurable. As a result, they should be considered at the beginning of the study design.
When integrated into frameworks early on, they can shape downstream analytical strategies, providing consistency throughout different developmental phases, spanning pre‑clinical to late‑stage clinical.
In doing so, they give sponsors confidence that data generated will endure over time. A one‑off test may answer a short‑term question, however, a validated assay becomes infrastructure and can support a program for years to come.
Expertise in infectious disease
hVIVO’s lab expertise is ideal for infectious and respiratory diseases. They built platforms that support human challenge research, vaccine development, and antiviral testing. That includes investing in molecular biology, immunology, and microbiology capabilities, and building teams committed to developing and validating assays.
With the passage of time, those building blocks became a foundation that can be used over and over in a portfolio of research.
Expanding the architecture
Today, these foundations are expanding. hVIVO has added digital PCR, Ligand binding assay diversity, multiplexing, and next-generation sequencing, as well as robotics and automation, all while extending its capabilities in both microbiology and cell culture. These platforms enable work with smaller sample volumes, elevated throughput, and more flexibility.
They also open possibilities for novel indications ranging from oncology and metabolic disease to cardiovascular research and gene therapy. The same architectural approach is applicable – develop the assays, validate them, and then use them as infrastructure to aid long‑term development.
From infectious disease to more general translational science
hVIVO is excited about the agility this gives sponsors. They can combine platforms, adjust assays for specific development stages, and adapt to novel therapeutic domains.
Whether for neutralizing antibody assessments in vaccine research, creating biomarker panels in oncology, or microbial propagation for antibacterial programs, the underlying principle remains the same: assays provide the framework that binds the science together.
Closing thought
Assays are architecture, not just tests. They form the foundations upon which translational research can be built, providing the framework that enables innovation to scale across indications and phases.
By treating assays like building blocks, hVIVO creates infrastructure that supports sponsors from the early discovery phase to clinical development - ultimately helping in the provision of better therapies to patients.
About the authors
Elisa Masat (PhD) is Principal Scientist at hVIVO. Leading a dedicated research and development team of eight scientists, researching, building, qualifying, and validating platforms in diverse technical domains. An expert in Immunology, Elisa has worked in other roles at hVIVO and at Charles River.
Chris Forsdyke is head of Laboratory Operations at hVIVO. He leads the transformation of hVIVO lab operations and efforts to scale its lab infrastructure and teams to serve users in pre-clinical through to clinical trials. Previously, Chris has held positions in Biotech and Pharma at companies including Lonza, Covance, and PPD.
About hVIVO
hVIVO is a full-service early phase CRO offering end-to-end drug development services from preclinical consultancy through to Phase III clinical trials, including world-leading end-to-end human challenge trials services. With decades of experience in rapidly delivering data for our global client base, our team brings together strategic insight and operational expertise to deliver a variety of clinical study types across multiple locations.
To support rapid study start-up and reliable delivery, our dedicated recruitment teams in Germany and the UK provide direct access to both healthy volunteers and patient populations. This is complemented by our integrated drug development consultancy, as well as our infectious disease and immunology laboratories and biobanking services.
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