Transforming Clinical Bioanalysis for Manufacturing Scalability

With the average cost of developing a drug hovering around $2.7 billion (1), and total industry research funding at approximately $276 billion (2), efficiency is no longer optional, says Ely Porter, PhD, chief scientific officer, Dash Bio, at the American Association of Pharmaceutical Scientists’s 2025 PharmSci 360 conference.

In his talk, “Accelerating Clinical Bioanalysis: Transforming the Industry with Automation and Tech First Approaches,” Dr. Porter notes that the integrity and speed of clinical bioanalysis are paramount. Yet, industry satisfaction with outsourced bioanalysis remains exceptionally low, sometimes "abysmal," as he describes it, explaining that this gap between investment and satisfaction underscores a critical need for transformation.

Traditional bioanalysis is often heavily reliant on manual labor, processes that lag behind general technological progress, Dr. Porter says. Data transfer still frequently involves non-integrated methods like USB drives or email, and quality assurance cycles can span weeks or months. This reliance on manual workflows introduces significant risk and prevents the speed and precision required for modern drug development, he explains.

Why is the traditional bioanalysis model unsustainable for modern pipelines?

The slow pace and complexity of traditional methods create critical delays that impact an entire program schedule, Dr. Porter emphasizes. For those managing large-scale manufacturing and clinical timelines, a delay in obtaining toxicology data can be catastrophic, potentially “pushing a program back by nine months if a scheduled slot is missed,” he says.

As Dr. Porter sees it, technology-first strategies are now revolutionizing the sector by delivering the flexibility and scalability necessary to accelerate clinical bioanalysis timelines. The industry anticipates approximately 10,000 molecules currently waiting in AI pipelines for development, demanding platforms that can handle massive throughput without sacrificing quality, he explains.

How are automated LES improving data compliance and quality control?

Automation systems are moving beyond simple data tracking to function as laboratory execution systems (LES), actively controlling equipment movement, ensuring adherence to protocols, and achieving compliance (e.g., Code of Federal Regulations 21 Part 11) within a compliant cloud environment, Dr. Porter adds.

He notes that this integration delivers a robust chain of custody through automated barcoding and tracking, aggregating environmental conditions, and minimizing potential deviations. This level of control allows quality assurance to shift toward "review by exception," he states.

Can faster bioanalysis truly prevent major drug development delays?

Speed is perhaps the most tangible benefit for drug development professionals with faster bioanalytical methods. As Dr. Porter states, modern platforms are leveraging high-pressure liquid chromatography–mass spectrometry (LC–MS) methods to achieve run times that come in at under two minutes, a dramatic improvement over the 10-to-15 minute methods that could consume the "better part of a week" for large batches, he states.

This speed directly enables what Dr. Porter calls adaptive study designs. Reducing turnaround times dramatically—such as delivering data for a critical study in three days—allows researchers to adjust dosing or strategy quickly, preventing the nine-month program setbacks Dr. Porter mentions. Increased precision is “a key factor here,” with automation systems tracking timing variance down to 133 milliseconds (0.02%), he says.

Dr. Porter concludes that, ultimately, the goal is to shift away from the opaque, traditional cost-plus model that is often defined by unexpected change orders toward a more transparent value-based pricing structure. He stresses that industrializing clinical bioanalysis through advanced automation is necessary to manage the hundreds of millions of clinical tests required globally, ensuring new therapies can reach viability faster and with higher fidelity.

The AAPS PharmSci 360 2025 conference runs Nov. 9–12 in San Antonio, Texas. Click here for more conference coverage.

References

1. Roden, B. The Staggering Cost of Drug Development: A Look at the Numbers. greenfieldchemical.com, Aug. 10, 2023.
2. Chandra, A.; Drum, J.; Daly, M.; et al. Comprehensive Measurement of Biopharmaceutical R&D Investment. Nat. Rev. Drug Discovery online. Aug. 6, 2024.
3. Dr. Porter, E. Accelerating Clinical Bioanalysis: Transforming the Industry with Automation and Tech First Approaches. Presentation at 2025 AAPS PharmSci 360, San Antonio, Texas, Nov. 9–12, 2025.