Bioprocess Online for bioanalytics, biopurification, bioproduction

Smart assistant tools technology concept, excellence quality artificial intelligence equipment, application and program-GettyImages-2218177130

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.

More Featured Editorial

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

The Next Leap In Pharma Manufacturing
Explore how Industry 4.0 integration transforms pharma manufacturing through connected systems, data-driven insights, and predictive, compliant operations.

Handling Protocols: Key Considerations In The Highly Potent API Market
5/12/2025

Explore the growing role of highly potent active pharmaceutical ingredients in oncology and Antibody-Drug Conjugates to highlight manufacturing challenges, safety protocols, and opportunities for CDMOs.
Is Mannitol Hemihydrate Detrimental To Protein Stability?
10/16/2024

Maintaining an amorphous excipient matrix is crucial for protein stability. Learn about the importance of storage conditions in managing mannitol hemihydrate dehydration and ensuring protein stability.
Designing, Selecting, And Developing Bioconjugates For Clinical Success
10/24/2024

Accelerate the development of complex bioconjugates to unlock new possibilities for targeted therapies and advance the next generation of precision medicine.
Streamlining Single-Use Assemblies In The Bulk-Fill Step Of Downstream Processing
4/24/2024

Single-use (SU) systems and components are growing in demand as they offer minimal contamination risk. Review a standardized SU assembly for bulk-fill processing that aims to improve efficiency.
If You Can't Win The Game, Change It
12/11/2024

Explore how eData sharing is used in the biopharma market, enabling standardized, collaborative supply chains that reduce risks and enhance visibility while improving capacity planning.

More Bioprocessing White Papers

BIOPROCESSING APP NOTES & CASE STUDIES

More Bioprocessing App Notes & Case Studies

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.