Biopharmaceutical Analysis

CGT is rapidly transforming oncology and rare disease research, with patient-derived models, advanced imaging, CRISPR/Cas9, and 3D organoids driving innovation while solid tumor modeling remains a critical frontier.

While allowing for high throughput and efficiency, the bulk fill/finish process exerts extreme stress on glass containers, resulting in cosmetic defects and breakage.

With Sanofi as one of its backers, Earendil Labs is set to advance its AI-native biologics platform to scale antibody discovery, accelerate IND filings, and expand partnerships in autoimmune and oncology research.

The company is targeting the $3 billion pancreatic cancer market with its lead proenzyme therapy candidate, PRP, which is supported by strong preclinical tumor inhibition data and for which a PK assay will be developed and validated.

A newly engineered CHO host from Sartorius, developed through proteomic profiling and targeted genome editing, demonstrates up to three-fold productivity increases and accelerated nine-week cell line development timelines, supporting more stable, high-titer biomanufacturing for biologics and biosimilars.

Under the collaboration, Merck and Mayo Clinic will integrate multimodal clinical and genomic datasets with AI models to enhance target biology insights and translational decision-making.

Spectral flow cytometry is democratizing high-parameter cell analysis, using modular instruments and AI to unlock deeper insights in cancer research.

Phase III data show that Gazyva/Gazyvaro (obinutuzumab) significantly improved complete remission rates at two years compared with tacrolimus in adults with primary membranous nephropathy, with additional benefits seen across key secondary endpoints and no new safety signals identified.

Lonza’s Michael De Marco emphasizes that early tox milestones strengthen investor confidence, support funding decisions, and reduce development risk for emerging biotechs.

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Next-gen antibody R&D is shifting to multifunctional modalities driven by manufacturing scale and regulatory acceleration.

In part two of an interview, Daniel Delubac, iOrganBio CEO, explains how digitized, in-vitro human biology models aim to improve preclinical drug testing.

In a new team-up, MD Anderson and SOPHiA GENETICS will apply advanced analytics to cancer testing to improve complex data interpretation for clinical use.

A look at interchangeable biosimilars gaining FDA approval, the growth in global partnerships, and the rising biologics patent cliff.

Advances in precision analytics have pushed the needle forward in characterizing and assessing the safety and quality of next-gen biologics.

FDA outlines reduced primate testing for monoclonal antibodies, signaling a shift toward modern evaluation tools that may influence drug development practices.

Microfluidic rapid-testing advances enhance real-time QC, strengthen compliance, and speed contamination detection across modern biomanufacturing.

Eric Hill, Chief Scientific Officer, BA Sciences, discusses the how E&L testing principles can be adapted to biologic products and the unique challenges biologic drugs face regarding E&Ls.

Eric Hill, Chief Scientific Officer, BA Sciences, discusses the analytical challenges involved in conducting E&L testing for biologic drug products.

Reliable bioanalysis and regulatory-compliant study design enhance drug development, says Alturas’s Sara Underwood at AAPS PharmSci 360.

At AAPS PharmSci 360, Ely Porter, PhD, says automated platforms enhance drug production velocity and assay excellence.

Performance advantages are driving adoption of membrane chromatography for advanced therapy purification.

A wide-ranging discussion with RNAnalytics’ Viktoria Enkmann touched upon the technology and equipment necessary for modern nanoparticle analysis, as well as global concerns.