Newsletter | March 20, 2026

03.20.26 -- Pursuing Quality While Maintaining Process Control With Richard Moroney, Ph.D.

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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 REGULATORY

Pursuing Quality While Maintaining Process Control With Richard Moroney, Ph.D.

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Richard Moroney, Ph.D., managing director at Stat Consulting.

Key Challenges And Solutions To Enable A New Frontier In Cancer Treatment

Multispecific antibodies are a newer class of cancer therapeutics addressing tumor complexity. Learn about the design, manufacturing, and regulatory challenges.

Excipient GMP: Elevating Standards In Cell Culture Solutions

The quality of non-active ingredients, or excipients, directly impacts product safety and efficacy. See why Excipient GMP is vital for cell culture solutions and how it elevates manufacturing standards.

FOCUS ON QUALITY/ANALYTICAL METHODS

Forge Boosts Efficiency And Compliance During External Collaboration

Streamlined collaboration and unified quality systems are helping CDMOs cut review times. Discover how connected workflows improve compliance and efficiency for faster delivery of life-changing treatments.

Modeling Colorectal Cancer Progression

Gain a better understanding of the microenvironment's role in colorectal cancer progression by reviewing the integration of Organ-Chip models with high-content imaging and mass spectrometry.

AI Implementation To Enhance Quality

Examine how solutions driven by artificial intelligence can enhance compliance, optimize workflows, and drive efficiency in biopharma operations.

Stick With Me: The Cool Chemistry Of HILIC Oligonucleotide Analysis

Explore a powerful alternative for analyzing polar sequences without ion-pairing reagents. By leveraging hydrophilic partitioning, you can achieve sharper separation and improved mass spectrometry.

Why You Should Not Rely On Western Blotting For HCP Antibody Coverage

Legacy methods often mask critical impurities. Find out why traditional blotting may be jeopardizing your regulatory data and how to implement more sensitive, objective alternatives.

Residual iPSC And Genomic Stability Testing With High Multiplex Digital PCR

Sensitive digital PCR methods enable confident detection of low‑abundance iPSC markers. Gain insight into how these capabilities support more reliable monitoring and quality assessment.

Safeguarding Quality In Parenteral Drug Manufacturing

Observe how vision inspection software helps injectable drug manufacturers meet USP <790> standards by improving defect detection, ensuring data integrity, and eliminating paper-based risks.

A New Transfection System Tailored For Optimized AAV Production

In AAV manufacturing, long-term success depends not just on titers, but on maximizing the percentage of full capsids to ensure efficacy, safety, and scalability.

PAT Monitoring And Control Roadmap

Learn how to implement PAT effectively with a roadmap that covers techniques, validation, data integrity, and lifecycle strategies to help teams improve quality, control, and productivity.

Using SEC For Reliable Biotherapeutic Peptide Analysis

Uncover a breakthrough in analytical performance that delivers unmatched precision, faster results, and reduced waste. This innovation sets a new standard for sustainable, high-resolution analysis.

Don't Let Seals Break Your Batch: A Risk-Based Approach To Maintenance

Optimize biopharmaceutical manufacturing by implementing risk-based seal maintenance. Tailor replacement protocols using data and advanced monitoring for enhanced efficiency and compliance.

Logical Scale Out Before Scale Up

Read about how synthetic biology and a "scale-out" biomanufacturing strategy can unlock "infinite diversity in infinite combinations," optimizing MSC functionality for superior outcomes.

Preclinical Development: A Successful Transition To cGMP Manufacturing

Delve into the development steps that lead to an mRNA construct optimized for your requirements and that meets future-proof cGMP manufacturing requirements, thereby de-risking the development.

A Comparison Of Sizing And Quantification Performance

Review how automated electrophoretic analysis improves protein QC by delivering sharper sizing accuracy, stronger quantitative linearity, and greater consistency than conventional gel workflows.

QUALITY/ANALYTICAL METHODS SOLUTIONS

Life Sciences Partner For High-Purity Chemicals And Custom Solutions - Greenfield Global

Unlock The Power Of Automated Cell Isolation - Miltenyi Biotec

Validation Doesn't Need To Bleed Time Or Money - ValGenesis

A Solid Foundation For Pushing The Limits Of Spectral Flow - BD Biosciences

Explore A New Imaging System That Offers Faster Scans - LICORbio

A Capillary Electrophoresis System That Simplifies Protein Analysis - Agilent Technologies

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