Newsletter | March 6, 2026

03.06.26 -- How Is U.S. Policy Reshaping Global Biomanufacturing Operations?

SPONSOR

Regulators are shifting the biosimilar approval paradigm — prioritizing deep process understanding over large clinical trials. In this evolving landscape, defining and controlling CPPs is essential to demonstrating high similarity. Join Bioprocess Online’s Jon O’Connell on March 24th at 11 am Eastern for a live Q&A with Sarfaraz Niazi, Ph.D., Vince Narbut, and Diana Colleluori, Ph.D., as they explore how QbD and CQA insight can streamline development and regulatory success.. Register for free today thanks to support from sponsor Cytiva.

FOCUS ON QUALITY/ANALYTICAL METHODS

The Sleek Science Of Ion Pair-Reversed Phase Oligonucleotide Analysis

Master oligonucleotide separation by balancing hydrophobic and ionic interactions. Learn how selecting the right cationic pairing agent optimizes retention and compatibility with mass spectrometry workflows.

Predicting Hepatotoxicity With The Liver-Chip

Enhance your understanding of liver organoids and their pivotal role in enhancing DILI risk prediction through the use of advanced Organ-Chip technology.

Regulatory Compliance And Solutions For Aseptic Environmental Monitoring

Modern aseptic monitoring requires a shift from periodic checks to risk-based strategies. Learn how to integrate particle and environmental data to meet Annex 1 standards and ensure patient safety.

Principles And Practice Using SEC For Reliable Peptides Analyses

Discover new SEC columns that enable reliable separation of biotherapeutic peptides to enhance CQA measurements for improved safety, efficacy, and quality across LC platforms.

Accelerating Batch Release With Agentic AI

Agentic AI is redefining manufacturing by accelerating batch release and sharpening real‑time insights. With the right data and governance, teams can gain faster analytics and improved efficiency.

Choosing The Right Sample For HCP Antibody Coverage Analysis

Selecting the right sample is vital for accurate HCP antibody coverage. Find out how to navigate the limitations of traditional methods and ensure your ELISA is truly fit-for-purpose.

Multimeric VHH Nanobody Expression

Engineering multimeric antibodies via refined secretion leaders and screening improves avidity plus half-life. Such concatemers offer a faster way for making therapeutics with high activity.

Ensuring Viral Safety Through Multiplexed Adventitious Virus Detection

Gain a targeted look at multiplex digital PCR that detects diverse human viral contaminants with speed, sensitivity, and precision. Explore how high‑multiplex workflows support QC needs.

Studying Antigen Escape In B-ALL

Researchers uncovered a mechanism of antigen escape linked to low Ikaros expression in tumor cells, offering insights into CAR-T treatments. See how multi-omic analysis enabled this discovery.

The Rising Cost Of Product Recalls In Life Sciences

Product recalls are becoming a major concern in life sciences. Uncover why your company must act now to strengthen quality systems and reduce risk across pharmaceuticals, devices, and biologics.

Manual CQV Vs. AI-Powered CQV

Still validating the manual way? With AI-powered CQV, you can reclaim hours lost to protocols and audit prep. What used to take weeks is now done in minutes.

Sensitive Monitoring Of CAR+ T Cells In Peripheral Blood

Investigate how CAR-T cells treat hematopoietic malignancies as well as the correlation between flow cytometry and qPCR in monitoring, which validates their combined use for accurate assessment.

EV Analytics: Know Your Process & Define Your Product

Observe how EV analytics will help you analyze your process and define your product, while learning about EV manufacturing strategies and MISEV guidelines.

Quantitative Western Blot Analysis With Replicate Samples

Learn how to design, normalize, and interpret replicate western blot experiments to ensure reproducible protein quantification with fold change calculations, CV analysis, and visualization strategies.

QUALITY/ANALYTICAL METHODS SOLUTIONS

A Human-Relevant Liver Model With Minimal Drug Absorption - Emulate

Resilience: Accelerating Innovation With Unified Quality - Veeva

Transform GMP Data Into Actionable Intelligence - Blue Mountain

Biologics Analytical Services - Catalent

FOCUS ON REGULATORY

How Is U.S. Policy Reshaping Global Biomanufacturing Operations?

In this opening segment from the Bioprocess Online Live event, “Protecting Bioprocessing Operations and Supply Chains In A Turbulent Economy,” panelists Adam Golin, Jon Lindbloom, and James Sapirstein speak candidly about how U.S. tariffs are affecting the global operating environment.

Cold Chain Compliance Standards You Should Know About

Regulatory frameworks for biopharmaceutical cold chain management are more interconnected than most manufacturers expect — and the gaps between them are where compliance risk lives.

FAQs On The Revised EU GMP Annex 1: Volume 8

Successfully implementing a site-wide CCS requires prioritizing barrier technologies, integrating primary packaging into risk assessments, and adopting a data-driven approach to environmental monitoring.

Top Safety Considerations In Biopharmaceutical Manufacturing

Understanding top safety concerns, from combustible material handling and chemical exposure to HPAPIs, is the first step toward preventing accidents in biopharmaceutical manufacturing environments.

Connect With Bioprocess Online: