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Building Enterprise Resilience From QRM Signals

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

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.
Ask The Pros — The Latest In Upstream HCP Mitigation
We asked leading experts how upstream interventions can reshape HCP control. Here’s what they shared. Answers have been edited for clarity.
2026 CDMO Forecast: The 7 Shifts Sponsors Need To Prepare For
2026 is shaping up to be a year in which operational discipline, strategic alignment, and regulatory preparedness will differentiate high-performing sponsors from those facing avoidable delays.
Biosimilar Manufacturing Complexity Demands Mastery, Not Mimicry
GlycoNex's denosumab biosimilar development experience illustrates how a "just copy it" approach is an insufficient strategy in modern biomanufacturing.
A Deeper Look At Pharma's Structural Supply Chain Vulnerability
Fixing limited capacity in pharmaceutical CMC development starts with understanding a complex web of root causes.

BIOPROCESSING WHITE PAPERS

Reducing ADC Timelines With Integrated Development And Manufacturing
ADCs have proven to be highly effective in cancer treatment, but their manufacturing poses challenges. Learn how a CDMO partner can help bring these treatments to patients safely and efficiently.

Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer
3/24/2025

Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency and innovation in bioprocessing workflows.
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.
Unlocking ROI And Capacity In Monoclonal Antibody Manufacturing
11/5/2025

Perfusion-based upstream production offers up to 24% lower cost and significantly higher productivity than fed-batch, enabling faster timelines, better facility utilization, and improved quality.
Quality By Design (QbD) For Biologics From A CDMO Perspective
2/18/2025

Adopt QbD principles in your biologics development and manufacturing process to ensure consistent product quality, mitigate risks, and align with patient safety and commercial success goals.
Accelerating ADC Clinical Development Timelines
8/28/2024

For ADC developers, obtaining the desired payload can be a challenge, as their synthesis is more complex than most other small molecules. Learn about a more efficient approach to payload synthesis.

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.