Advances in synthetic biology, molecular biology, and precision medicine have transformed drug discovery and development. Researchers are now leveraging targeted, data-driven strategies that use multiomic and bioinformatic technologies to identify disease-specific biomarkers and therapeutic targets. By enabling therapies to be tailored to the unique genetic and molecular characteristics of individual patients, scientists can more efficiently develop more effective therapies with fewer adverse effects.

Drug Development & Delivery recently interviewed Dr. Anjali Shah, Senior Director and General Manager, PCR Business, Molecular Biology at Thermo Fisher Scientific, to discuss how molecular biology technologies are transforming drug discovery and development and how Thermo Fisher is supporting customers across the biopharmaceutical innovation pipeline.

Q: As biopharma faces pressure to move faster with tighter budgets and leaner pipelines, how is this reshaping customers’ needs for molecular biology tools and workflows?

Biopharmaceutical drug discovery and development teams are evaluating molecular biology tools on their ability to accelerate timelines, reduce technical risk, and improve experimental productivity. Solving those challenges has put greater focus on innovations that enable higher-quality data generation, improve laboratory efficiency, and reduce costs. This includes practical solutions such as ready-to-use and room-temperature-stable reagents, simplified protocols, and more intuitive instrument software. Researchers also need standardized, pre-validated workflows that can be implemented quickly and reliably reproduced across teams and sites.

Q: As drug developers work across complex therapeutic modalities —including cell and gene therapies, RNA-based therapeutics, and biologics — how is the role of PCR evolving in development and characterization workflows?

PCR technologies play a critical role across every stage of the drug discovery and development continuum. During early discovery, endpoint PCR enables faster hypothesis testing and decision-making by helping to eliminate false leads early in development. It can help researchers confirm construct integrity, screen colonies and clones, verify genome integration events, and assess engineered cell or ex vivo models across multiple therapeutic modalities. Once constructs are verified, PCR-based methods can help provide confidence that biological signals are genuine before programs advance to translational and clinical development.

Today, endpoint PCR has evolved well beyond simple gene presence or absence testing. Modern applications include multiplex construct verification, panel-based confirmation, and validation of genome editing or transfection events using platforms such as our PowerFlex™ Thermal Cycler*. These capabilities help ensure that only correctly engineered systems progress through the discovery pipeline and can help teams avoid committing resources to more expensive downstream work.

Q: As qPCR, digital PCR, electrophoresis, and sequencing are used together, what does an integrated molecular analysis workflow look like for modern drug discovery?

Across cell and gene therapies, RNA therapeutics, and biologics, integrated molecular analysis workflows bring several complementary technologies together. Endpoint PCR and electrophoresis provide rapid identity confirmation and routine quality assessment. Quantitative PCR (qPCR) and digital PCR (dPCR) enable sensitive quantification, potency testing, and copy number analysis. Sequencing technologies, such as Sanger sequencing, NGS, and fragment analysis, provide comprehensive sequence verification.

An effective integrated workflow connects sample preparation, PCR, cloning, expression analysis, sequencing, data analysis, and documentation through standardized processes that reduce manual intervention and turnaround time. At Thermo Fisher, we focus on quality, reproducibility, application performance, and cross-platform compatibility across a portfolio spanning the molecular biology workflow, making it easier for customers to bring these technologies together.

Q: What areas of drug development are creating the greatest demand for innovation in PCR and nucleic acid analysis?

The discovery and early research phases continue to drive strong demand for innovation in PCR and nucleic acid analysis, particularly in oncology, cardiometabolic disease, neuroscience, and immunology. In these areas, researchers often work with complex, low-input, or variable-quality samples, so they need extraction, reverse transcription, and amplification solutions that generate reliable results without compromising quality.

Synthetic biology has also expanded demand for multiplexed PCR panels that enable simultaneous verification of multiple genetic targets and rapid characterization of cell lines, clones, and engineered models before functional screening. Similarly, genome-editing applications rely on endpoint PCR to confirm targeted insertions or deletions and rapidly screen large numbers of candidate clones before confirmatory sequencing.

Scalability is also critical, particularly as programs move from low-throughput feasibility studies to high-throughput screening. Features such as integrated quality controls, lyophilized reagent formats, liquid-handling-optimized chemistries, onboard reagent stability, and molecular barcoding for sample traceability can support efficient automation and scaling.

Finally, PCR instrumentation is becoming more tightly integrated with laboratory informatics, including laboratory information management systems, electronic laboratory notebooks, cloud-based data environments, and bioinformatics pipelines. Embedded quality-control analytics and standardized APIs can reduce manual data handling and enable more efficient data analysis and AI-driven decision-making.

Q: What differentiates Thermo Fisher’s approach to supporting customers compared with other providers in the market?

Thermo Fisher offers one of the industry’s broadest portfolios of molecular biology technologies, supporting customers from early discovery research through clinical manufacturing and commercial production.

We deliver integrated workflow solutions spanning sample preparation, molecular analysis, sequencing, automation, and informatics that help biopharma customers standardize workflows and scale efficiently as programs advance through development. For example, our Invitrogen™ E-Gel™ Power Snap Lite Electrophoresis System* combines gel electrophoresis and imaging on a single platform, allowing researchers to verify nucleic acid samples with reduced hands-on time and improved consistency. This breadth allows us to support customers across different therapeutic modalities and as their programs advance through development.

Q: What changes do you expect will shape PCR and molecular analysis over the next three to five years?

I think PCR and molecular analysis will continue evolving from standalone analytical techniques into more integrated and automated workflows. AI will be one of the most transformative drivers of this evolution, enhancing not only data analysis and interpretation but also experimental design and workflow optimization.

Beyond AI, several additional trends are expected to shape the field. We will likely see greater automation, enabling more integrated end-to-end workflows. The use of digital PCR is also expected to expand applications such as absolute quantification, viral safety testing, and potency assessment as more advanced therapies move from the lab to the clinic. Multiplexing capabilities will likely grow as well, allowing more biomarkers to be measured within a single reaction while helping reduce sample input requirements, assay costs, and turnaround times.

We also expect wider use of connected instrumentation and real-time process analytics to support manufacturing and quality control. Finally, regulatory digitalization is likely to grow, driven by AI-assisted documentation, automated data integrity verification, and integration with electronic batch records.