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Leveraging Conventional Therapeutics Skills For Cell And Gene Therapy

Cell and gene therapies share fundamental objectives with conventional biologics. Their common challenges offer a natural starting point to solving downstream bottlenecks.

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EDITOR'S DESK

FDA Releases Draft Guidance To Accelerate Biosimilar Development
New FDA draft guidance aims to reduce the timeline and cost of developing biosimilars.

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.

GUEST COLUMNISTS

New ISPE Framework Targets Uncertainty In Pharma's AI Deployment
International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.
Facility Considerations When Retrofitting Legacy Sites For ADCs
Antibody-drug conjugate manufacturing requires, among other things, unidirectional flow and air locks for people and materials. Facilities often lack these attributes.
In Vivo's Biggest Threat — Comparison To Old Models
In vivo CAR-T is not simply ex vivo without a manufacturing step. It is a different modality that relies on biological systems to regulate outcomes.
Managing Supply Chain Risk In Scale-Up And Multisite Trials
Scaling trials across sites can lock in supply risk early. Learn how biologic variability, long lead times, and multisite complexity threaten trials and how to spot warning signs fast.
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.
Why Use Total Organic Carbon Analysis For Cleaning Validation?
Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.
December 2025 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
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.

BIOPROCESSING WHITE PAPERS

Process Analytical Technology In The ADC Bioconjugation Process
Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC production.

Advances In Regulations For Viable Environmental Monitoring
2/21/2025

Viable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.
Leading European CDMO For Drug Product Manufacturing
6/2/2025

As timelines tighten and regulatory demands grow, discover how a European CDMO delivers integrated solutions from aseptic fill and finish to packaging and release.
Handle Single-Use Technology Biopharma Waste: Data Sharing, Collaboration
7/7/2025

Learn more about data sharing and collaboration to enable a better environmental impact of single-use technologies (SUTs) and quantifying the single-use plastic waste generated when manufacturing mAbs.
Performance Of HEKima™ Adherent HEK Cell Medium
9/16/2024

Explore the performance of a serum-free medium designed for HEK-293 cells, comparing its efficacy to traditional media for protein expression and cell proliferation.
Is Sustainability The Key To Agile Biopharma Manufacturing?
3/18/2025

In biologics manufacturing, change is constant. Discover how new innovations and a focus on sustainability have gotten 62% of executives to prioritize eco-friendly practices, which reflects a commitment to long-term viability.

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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.