Key takeaways from the 20th annual WRIB Conference The 20th annual WRIB conference convened a cross-section of global stakeholders to examine the evolving bioanalytical landscape. This year’s discussions made one thing clear: the field is moving decisively toward science-driven, risk-based frameworks, with increasing regulatory alignment across regions and modalities. These shifts reinforce the need to […]

The 2026 Well Characterized Biological Products (WCBP) conference offered a timely snapshot of where biopharmaceutical development is heading—and where regulatory expectations are tightening. Across regulators, consultants, sponsors, and CDMOs, one message was consistent: the bar for defending analytical and comparability decisions is rising, particularly as reshoring accelerates and biologics become more complex. Companies are no

Bispecific antibodies aren’t just “two antibodies in one”; the therapeutic advantage they provide is a dual, often synergistic mechanism of action. Yet most companies and contract research organizations (CROs) rely on templated platforms, resulting in potency assays that look fine on paper but fail in practice. When outsourcing support for your potency assays, be mindful

This year’s AAPS conference delivered strong scientific value and clear signals about where our industry is heading. Here are a few of the top trends shaping bioanalysis and biotherapeutic development: The Expanding Role of LC and LC-MS in Surfactant and Excipient Evaluation A recurring theme throughout the event was the need to modernize excipient and

Expert project management that provides transparency and close communication is essential when selecting a bioanalytical CRO. The objective of any project management pursuit is to complete the project on time, within budget, and within required quality or performance parameters. A bioanalytical CRO’s project management capabilities are key to ensuring that a bioanalytical services project runs

Good Manufacturing Practice (GMP) stability testing and GMP release testing for large-molecule biopharmaceuticals and proteinaceous In Vitro Diagnostic (IVD) reagents are uniquely challenging. These products—such as proteins, antibodies, and nucleic acids—are: Because of this complexity, they require sophisticated analytical techniques to ensure molecular integrity and batch-to-batch consistency. Partnering with a bioanalytical CRO that offers state-of-the-art

In the rapidly evolving landscape of pharmaceutical development, choosing a bioanalytical CRO that is proficient in advanced analytical methodologies and complies with all applicable regulatory requirements is essential. Partnering with a bioanalytical services provider equipped with CLIA (Clinical Laboratory Improvement Amendments), GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice), and GCP (Good Clinical Practice) certified

Accurate and reliable bioanalytical services play a critical role in innovators’ decision-making and the success of pharmaceutical products. Working with a bioanalytical CRO that offers comprehensive bioanalytical services and can support the entire product lifecycle from late discovery through commercialization provides strategic advantages through streamlined processes, continuity, efficiency, faster time to market, cost reduction, and