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In Vivo's Biggest Threat — Comparison To Old Models

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

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.
Building Enterprise Resilience From QRM Signals
Turn enterprise resource management (ERM) from a checklist into a true decision system — so risk informs everyday choices before quality events become supply disruptions, delays, or regulatory exposure.
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.

BIOPROCESSING WHITE PAPERS

Generate CHO-K1 GFP-Expressing Cells For Cell Line Development Workflow
Discover a high-efficiency workflow for generating GFP-expressing CHO-K1 clones using automated single-cell dispensing to achieve 93% isolation success and stable expression in under five weeks.

Project Management: Sphere Of Influence
10/21/2024

The project manager's sphere of influence extends beyond the project team, encompassing the organization, industry, and professional discipline.
Cell Line Development For Bispecific Antibodies
8/18/2025

See how the recently described cell line development paradigm shift, enabled by the Leap-In transposon platform, can extend to the development of bispecific monoclonal antibody-producing cell substrates.
The Stability Challenge In Biopharmaceutical Development
4/28/2025

Dive into a summary of stability considerations and process examples for recombinant proteins, mAbs, gene therapy, and subunit vaccines.
Digital Innovation And Sustainability Are Redefining Biomanufacturing
12/8/2025

Next Generation Manufacturing (NGM) integrates advanced process design, digital innovation, and strategic facility planning to facilitate agile, efficient, and sustainable biopharmaceutical production.
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.

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.