Analytical Testing

SCALE-UP & MANUFACTURING - Smart Formulation, Processing & Engineering Solutions to Solve Drug Product Scale-Up & Manufacturing Challenges With Minimum to No Regulatory Impact

Anil Kane, PhD, MBA, explains how many smart formulation process or engineering solutions can be applied to overcome challenges of the material properties to successfully manufacture quality products at the development and commercial scale with minimum to no clinical or regulatory impact.

MDI CHARACTERIZATION - Closing the Gap Between In Vitro Test Data & the In-Use Performance for Metered Dose Inhalers

David A. Lewis, PhD, presents experimental data that shows how certain modifications to the Pharmacopoeial test methods used for MDIs may result in data that is more indicative of real-life performance, providing insight that can be used to enhance drug delivery characteristics.

ASSAY VALIDATION - Biomarker Assay Validations – A Time for Change?

John L. Allinson, FIBMS, believes despite the increased use of biomarkers, it appears that many researchers are still continuing to use the FDA guidance document for validation even though it only critically addresses the validation of assays to support PK evaluation, and also has a limited scope described within the document in terms of studies where it should be used.

SAMPLE PREPARATION MARKETS - Automation & Application Trends Drive Growth in Sample Preparation Markets

Christi Bird indicates sample preparation remains a critical task in many research and testing workflows across biopharmaceutical, basic research, clinical, and industrial applications. While the market lacks the hype and excitement of NGS, CRISPR/Cas9, or the microRNA and epigenetics boom several years ago, the sample preparation market will always be a slow and steady gainer on an already large market size.

BIOMARKERS - FDA’s Design Control Requirements for Biomarkers in Drug Development

Kaiser J. Aziz, PhD, says the availability of validated biomarker-drug companion products will enable the molecular diagnostics and pharmaceutical industries to develop and rely on new genomic biomarkers in order to elucidate disease pathways, stratify patient populations, and monitor safe and effective use of these products.

Frequently Asked Questions About Analytical Testing

What are the latest trends in analytical testing for pharmaceuticals?

Recent trends include advanced automation in lab processes, predictive in silico modeling, and the adoption of diverse analytical techniques to support evolving biologics, inhaled therapies, and personalized medicines.

How are CDMOs improving resilience in analytical supply chains?

CDMOs are using multi-sourcing strategies, expanding vendor bases, and implementing flexible automation solutions to mitigate risks related to material shortages, tariffs, and geopolitical disruptions.

What role does automation play in modern analytical labs?

Automation solutions—such as semi-automated inhaled product testing and plug‑and‑play instruments—are enhancing accuracy, efficiency, and agility in testing workflows.