Newsletter | May 30, 2025

05.30.25 -- Why Pharma Risk Assessments Should Include 'Working Together Alone'

SPONSOR

Raman Implementation. Made Simple.

Looking to monitor glucose, lactate and titer in real time in your bioreactor? The ProCellics™ Raman Analyzer, a process analytical technology (PAT) platform, now features embedded ready-to-use models for cell cultures using our proprietary standard mAb media, enabling immediate, real-time monitoring of glucose, lactate and titer – right from your first batch. No model development required, complexity removed, process understanding accelerated, fast-tracking automation strategies enabled. Contact our PAT experts to learn more!

FOCUS ON QUALITY/ANALYTICAL METHODS

Why Pharma Risk Assessments Should Include 'Working Together Alone'

By Andy O’Connor, ERA Sciences

When understood and managed properly, subjectivity becomes a source of creativity. It reveals hidden hazards and unlocks more effective risk controls.

AI's Potential To Aid Multispecific Analytical Characterization

By Vadim Klyushnichenko, Ph.D., Calibr-Skaggs Institute for Innovative Medicines

Orthogonal analytical techniques are essential to characterize CQAs, support regulatory submissions, and validate AI-predicted formulation strategies.

Shifting Drug Development With Advanced Analytical Characterization

Webinar | FUJIFILM Diosynth Biotechnologies

Explore the advancing mass spectrometry, biophysical characterization, automated sample preparation, and high throughput analytics required to deliver medicines in a safe, compliant, and efficient manner.

Biopharma Production And Quality Control With Electrophoresis

Case Study | Agilent Technologies

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.

How To Accelerate Thermal Stability Testing For High-Concentration Drugs

Article | By Calliste Scholl, Christine Nervig, and Neil Demarse, TA Instruments

Learn about an innovation that addresses a crucial need in antibody formulation development by enabling rapid, high-throughput thermal stability testing at formulation-strength concentrations.

Exploring Analytical Methods For Traditional And Unique Modalities

Webinar | Catalent

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.

Automated 12-Color Immunophenotyping of Normal Whole Blood

Application Note | By Farzad Oreizy, Angela Chen, Bao Nguyen, Chih-Hung Lai, Punam Roka, Beverly Lu, and Yang Zeng, BD Biosciences

In this study, a fully automated workflow utilizing the BD FACSDuet Premium Sample Preparation System integrated with the BD FACSLyric Flow Cytometer was assessed and compared to manual processing.

QUALITY/ANALYTICAL METHODS SOLUTIONS

•

Kona Multiomics Characterization Assay Services - Resilience US, Inc.

•

DNA2.0 - Gene Optimization And Synthesis - ATUM

FOCUS ON REGULATORY

AI Model Cards Make Function And Risk Easier To Understand

By Andy O’Connor, ERA Sciences

AI doesn’t follow predefined logic like traditional software. Here's a tool, including a downloadable template, to answer critical compliance questions quickly.

Streamlining Testing For Optimized mAb Production

Infographic | Thermo Fisher Scientific

Delve into the intricacies of mAb production, emphasizing the importance of accurate and precise testing at various production stages to help ensure product safety, quality, potency, and regulatory compliance.

ICH Q14 101: Applying AQbD To CMC For Regulatory Success

e-book | Labcorp Biopharmaceutical CMC Services

ICH Q14 provides comprehensive guidance on analytical procedure development, offering an invaluable framework for ensuring the development of regulatorily compliant analytical procedures.

Connect With Bioprocess Online: