Newsletter | February 12, 2026

02.12.26 -- Taking The First Steps Towards Digitalizing Biopharma Development

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BioPlan Associates is conducting its 23rd Annual Global Biopharmaceutical Manufacturing and Trends Analysis and needs your insights for the biopharma industry’s most comprehensive global benchmarking analysis! For over 20 years, BioPlan Associates has analyzed advances in bioprocessing, new technologies, and emerging trends, supported by global institutional and media partners. For all completed, qualified surveys, they'll offer an Amazon e-gift card, a copy of the summary results, and the 2026 Top Trends in Biomanufacturing White Paper.

FOCUS ON MANUFACTURING CONTROLS

Taking An Institutional Approach To PAT Implementation

In this segment from the Bioprocess Online Live event, “Aligning CMC And MSAT To Move PATs Out Of Pilot Mode,” our panelists emphasize the importance of strategic planning for PAT implementation and the value of cross-training. Mengyao Li, Ph.D., from Novartis suggests taking a stage-gated approach and starting with the “low-hanging fruit.”

Taking The First Steps Towards Digitalizing Biopharma Development

AbbVie's head of biologics purification development and digitization teams, Moiz Diwan, Ph.D., and independent technology consultant Kat Kozyrytska share their thoughts on AI and smart technology adoption in this recap of the Bioprocess Online Live event, “How Digital Tools Are Accelerating Biopharma Development.” 

Leveraging AI And ML For Better Biologics

For many bioprocessing applications, both artificial intelligence (AI) and machine learning (ML) can be used in every phase of development to support optimization and streamline repetitive processes.

Three Trends To Know Before Selecting Your CDMO

Learn more about the desire for deeper collaboration between innovator companies and their CDMO partners and why companies are seeking robust drug development capabilities in-house.

Model-Driven Genetic Design And Bioprocess Optimization Across Modalities

Traditional biomanufacturing relies too heavily on trial and error. By integrating AI and mechanistic models into early design, developers can overcome productivity limits and accelerate timelines.

9 Signs Your Pharma Operation Needs An Upgrade

Unplanned downtime, audit stress, and missed calibrations signal it’s time to rethink maintenance. Here are nine signs that your operation needs a modern EAM or CMMS to boost compliance and efficiency.

The GxP AI Podcast: Unveiling The AI Model Validation Cheat Sheet

Discover how AI is revolutionizing biotech manufacturing as Toni and Christian reveal the story, strategy, and regulatory impact behind their innovative AI model validation cheat sheet.

Connected Data: A Catalyst For Compliance And Smarter Decision-Making

Overcome data integrity challenges in your bioanalytical lab. Find out how a connected data strategy streamlines operations and enhances regulatory compliance.

N-1 Perfusion Strategies For Commercial-Ready Biologics

See how an approach with modular N-1 perfusion strategies shortens seed train timelines and reduces facility strain — enabling upstream processes that scale efficiently for commercial manufacturing.

MANUFACTURING CONTROLS SOLUTIONS

Computerized System Validation Services - Koerber Pharma

Advanced IoT Platform For Laboratory Management - PHC Corporation of North America

Enabling Boundless Automation In The Life Sciences Industry - Emerson

The Digital Suite For Process Lifecycle Intelligence - ValGenesis

Maximize Operational Readiness And Efficiency Without Compromising Quality - Siemens

FOCUS ON FACILITIES DESIGN

Real-Time Viable Particle Detection For Definitive Root Cause Investigation

Investigations into viable air excursions are difficult to perform using traditional methods. Examine why a real-time viable particle counter is key to providing process improvement.

Design–Build Cleanroom Projects: A Proven Risk Mitigating Methodology

Building the right cleanroom involves critical early decisions. Read about a methodical framework ensuring flexibility, compliance, and operational readiness from initial concept through delivery.

Extractables And Leachables In Advanced Therapy Medicinal Products

ATMPs challenge existing E&L practices in single-use manufacturing. Gain expert insight into regulatory gaps, risk management needs, and the urgency for tailored approaches.

FACILITIES DESIGN SOLUTIONS

Used 5,000 Liter Single Use Mixer - Federal Equipment Company

Meeting Demand For Enhanced Cleaning Protocols - Ecolab, Purolite™ Resins

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