08.01.25 -- What Did ICH Q14 Miss On Analytical Method Validation?

Learn the five essential principles of cleanroom particle counting and how they ensure compliance, prevent contamination, and protect product quality in highly regulated manufacturing environments.

Explore the power of Microfluidic Modulation Spectroscopy (MMS) in resolving distinct melting behaviors and domain-specific unfolding events for biologics, providing crucial structural insights for development and formulation.

Uncover how digital transformation is revolutionizing cleaning validation, as well as how automation, data-driven tools, and compliance innovations are streamlining processes and ensuring success.

Discover how Kaneka Eurogentec, a leading provider of custom DNA synthesis and molecular biology services, enhanced their fragment analysis to achieve higher efficiency and accuracy in their workflows.

Here, we review several challenges in biologics analysis and take a closer look at the advanced tools and methods being utilized to improve biophysical analysis reliability and efficiency.

Accurate nucleic acid quantification is vital for applications like PCR and NGS. Discover an RNA Assay Kit that offers precise RNA measurement to enhance reliability and performance in downstream assays.

Cell-based immunotherapy leverages immune cell types that are able to fight cancer due to their ability to recognize and activate to kill cancer cells. Explore the impact of immunotherapy on cancer treatment.

Watch to learn about solutions to address challenges in standardizing flow cytometry and cell analysis solutions that support drug development at every stage.

Struggling with data integrity challenges? Discover proven strategies for GxP compliance and inspection readiness in this essential webinar. Learn to build a robust framework and avoid common pitfalls.

Navigate the challenging path from concept to clinical reality by partnering with an experienced CDMO that can provide the regulatory, clinical, and CMC expertise needed to move your therapeutic forward and bring it closer to patients in need.

For Indian biosimilar developers looking to capitalize on the upcoming patent cliff, it is vital to play to your strengths and identify strategies for breaking into competitive regulatory markets.

Maintaining a cleanroom facility that remains safe for your workers – and where the therapeutics they produce remain safe for patients – can ease your compliance concerns.

Discover the strategies that helped a company navigate a complex and shifting regulatory landscape to rapidly re-engineer a COVID-19 vaccine manufacturing process for FDA compliance.