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The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing

The promise of AI is colliding with the harsh reality of data chaos in pharma manufacturing. This article explores why most AI investments fail, and a 5-layer solution.

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EDITOR'S DESK

Supporting The Next Generation Of ADCs
Experts discuss innovation in antibody-drug conjugate (ADC) technology and how these impact CMC strategy. This summary captures key takeaways from the Bioprocess Online Live event "Evolving CMC Strategies To Enable Next-Gen ADCs."

The 9 Fastest-Growing Outsourcing Segments

Capacity isn’t the choke point—capability is; this piece ranks nine fast-growing outsourcing segments and shows sponsors how to win by locking in modality-proven partners early.

AbbVie And Amgen's Blueprint To Digitalize Biomanufacturing

At BioProcess International 2025, leaders from AbbVie and Amgen gave keynote presentations about how their companies are advancing product development through digital tools.

On The Ground At BPI: Kat Kozyrytska On Ethical AI And Collaboration

AI consultant Kat Kozyrytska advocates for ethical AI adoption and explains its potential to foster collaboration across the industry.

On The Ground At BPI: Takeda's Amy Shaw On Scaling Cell Therapy Manufacturing

Takeda head of process development, Amy Shaw, explains what factors to consider when scaling up or scaling out cell therapy manufacturing.

GUEST COLUMNISTS

Do's And Don'ts Of Material Handling When Retrofitting For ADCs
Antibody-drug conjugate manufacturing includes extremely dangerous ingredients, and most legacy facilities lack the features and flows for safe handling.
Building Enterprise Resilience From QRM Signals
Single-Use Standards Are Maturing, But The Process Remains King
The food industry inspired single-use in biopharma, but the regulatory landscape is far more complex. If you're worried about compliance, this discussion can help.
Mind The Potent Compounds When Retrofitting Facilities For ADCs
Antibody-drug conjugate manufacturing introduces significantly more risk to employees. Likewise, facility safety requirements are especially intense.
New USP Research Shows MAM As Alternative To Conventional Methods
Results show the multi-attribute method provided superior specificity and detected molecular modifications far better than the status quo.
Deploying A Vendor Life Cycle Oversight Model
A practical guide for adding oversight, based on a hierarchy of metrics, to quality agreements to transform them into living, metrics-driven control instruments.
Moving Leukopaks From GTP To GMP Is One Cell Therapy Trend To Watch In '26
Cell therapy stumbled in 2025. Solving the variability in starting material quality is critical to stabilizing manufacturing in 2026.
Metrics, Not Audits, Should Lead Vendor Accountability
Episodic vendor audits are better suited for high-risk areas. An oversight system, based on a hierarchy of metrics, provides greater value.

BIOPROCESSING WHITE PAPERS

Vial Breakage During Lyophilization: Root Causes And Mitigation
Learn how controlling freezing rates, using specialized vials, and employing optimized stoppering techniques can reduce the risk of vial breakage during lyophilization and ensure high product quality.

Advancing A LNP Formulation To Clinical And Commercial Manufacturing
3/25/2024

Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.
Physiologix™ Serum Replacement Performance On Mesenchymal Stem Cells
9/16/2024

Learn about the effectiveness of a xeno-free serum replacement in mesenchymal stem cell (MSC) culture and its potential to enhance cell growth and reduce variability compared to fetal bovine serum.
Stopper Migration In Frozen Pre-Filled Syringes
10/16/2024

Review a semi-automated method for dynamically assessing plunger migration under controlled variations in temperature and pressure, utilizing computer vision tools.
Accelerating The Development And Production Of High-Quality bsAbs
3/7/2024

Bispecific antibodies (bsAbs) are revolutionizing medicine by targeting two disease mechanisms simultaneously. Learn about an innovative platform offering excellent pairing and enhanced productivity.
How Lipid Nanoparticles Enable Next-Gen Delivery
10/20/2025

Cell therapy’s future depends on smarter gene delivery. Learn how lipid nanoparticles offer a scalable, cell-friendly alternative to electroporation and viral vectors for manufacturing efficiency.

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BIOPROCESSING APP NOTES & CASE STUDIES

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BIOPROCESS ONLINE CONTENT COLLECTIONS

This collection of articles digs into the industry’s growing focus on knowledge management as an indispensable facet of biomanufacturing and pharmaceutical development, exploring how it plays into risk management, quality, vendor relationships, and supply chain resilience.