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FDA Releases Draft Guidance To Accelerate Biosimilar Development
New FDA draft guidance aims to reduce the timeline and cost of developing biosimilars.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

Stopper Migration In Frozen Pre-Filled Syringes
Review a semi-automated method for dynamically assessing plunger migration under controlled variations in temperature and pressure, utilizing computer vision tools.

The Importance Of Quality In Raw Material Selection
1/16/2025

Learn how to select high-quality raw materials for cell-based manufacturing in this exploration of the criticality of raw materials, from preclinical development to commercialization.
Quality By Design In The Pharmaceutical Industry
12/12/2025

Real-time release and digital quality management, powered by PAT, are driving efficiency and compliance, reshaping how manufacturers achieve speed, consistency, and competitive advantage.
Application Of Plant And Process Models
1/22/2025

Explore innovative process and facility models that optimize efficiency, sustainability, and cost-effectiveness in biopharmaceutical manufacturing.
Generation Of Stable CHO Cell Lines For Protein Production
3/22/2024

By following the five steps of a specialized protocol, exceptional yields and stable cell lines can be achieved in CHO cells using antibiotic selection.
Validation And Qualification Approach In New Annex 1 Revision
2/21/2025

The new Annex 1 revision emphasizes validation and qualification for sterile drug production. Ensure product quality and contamination control by learning about in-depth requirements for premises and equipment.

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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.