News, Events & Resources at Crystal Bio Solutions

ADC Bioanalysis: DAR Profiling and Stability Analysis

CBS Admin — Wed, 10 Jun 2026 11:00:00 GMT

Antibody-drug conjugates (ADCs) have become one of the most active areas of innovation in oncology. By combining the target specificity of monoclonal antibodies with the potency of cytotoxic payloads, ADCs offer a way to selectively deliver highly active therapeutics to tumor cells while limiting systemic exposure.

Heading to BIO International Convention 2026 in San Diego?

CBS Admin — Wed, 03 Jun 2026 09:36:29 GMT

Allan Cortes and Meina Liang will be at this year's BIO International Convention 2026 in San Diego ( June 22–25) and would love to connect with you there.

High-resolution Mass Spectrometry (HRMS) in Biologics Characterization

CBS Admin — Tue, 02 Jun 2026 11:00:00 GMT

As biologic therapeutics become increasingly complex, analytical characterization requirements continue to evolve.

Opening: Senior Scientist or Associate Principal Scientist, LCMS Platforms

CBS Admin — Thu, 26 Mar 2026 15:56:25 GMT

Opening: Senior Scientist or Associate Principal Scientist

CBS Admin — Thu, 26 Mar 2026 15:50:36 GMT

Opening: Manager / Director of Quality Assurance

CBS Admin — Thu, 26 Mar 2026 15:11:20 GMT

Antibody Glycosylation: FDA requirements and Characterization

CBS Admin — Mon, 23 Mar 2026 15:37:01 GMT

San Diego Biotech Networking Event 2026: CMC and Development Discussions

CBS Admin — Mon, 16 Feb 2026 14:48:51 GMT

What Does the FDA Require to Approve a Monoclonal Antibody Biosimilar in 2026?

CBS Admin — Mon, 16 Feb 2026 12:03:06 GMT

In 2025, the U.S. Food and Drug Administration (FDA) approved several monoclonal antibody biosimilars under section 351(k) of the Public Health Service Act only when sponsors demonstrate, through a totality of evidence, that there are no clinically meaningful differences from the reference product in structure, function, pharmacokinetics, immunogenicity, and clinical performance.

The 6 Most Common Analytical Gaps in Biosimilar Programs (and how to fix them)

CBS Admin — Wed, 04 Feb 2026 13:10:44 GMT

The main risk in modern biosimilar development is no longer failure to demonstrate clinical efficacy. It is the presence of analytical gaps introduced early and locked in later, when they are expensive or impossible to fix.