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DEA Reveals Hidden Costs Of Analytical Validation Guidelines

By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.

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EDITOR'S DESK

Overcoming Recovery Challenges In AAV Production
Siren Biotechnology's SVP of vector development, Nathalie Clément, Ph.D., explains the challenge of purifying AAV capsids and the ways developers are optimizing vector recovery.

Preserving Tacit Knowledge In ADC Tech Transfers

ADCs built on proprietary platforms risk losing process-specific knowledge during a tech transfer. See what advice panelists from the Bioprocess Online Live event "Ensuring Successful Technology Transfer In ADC Development" shared with the audience on preserving this implicit knowledge.

Multispecific Manufacturability Starts With Molecular Design

AP Biosciences’ VP of antibody discovery, Jhong-Jhe You, Ph.D., explains the key design elements of multispecific antibodies and how they affect product developability.

On The Ground At BIO 2026: Johanna Kaufmann, Ph.D., On The Oncology Modality Puzzle

At the 2026 BIO International Convention, Bioprocess Online caught up with Johanna Kaufmann, Ph.D., CSO at Deck Bio, a company developing multi-targeted T-cell engagers for solid tumors.

BIO 2026: Modernizing The FDA And Bolstering The Workforce

Bioprocess Online's chief editor, Tyler Menichiello, shares his key takeaways from the 2026 BIO International Convention in San Diego.

GUEST COLUMNISTS

Engineering Better ADCs, Part 2: Characterization, CMC, And More
Let's take a closer look at antigen selection and tumor biology, PK and PD, analytical characterization, CMC, toxicity, and more.
CDMO Selection Beyond Capabilities And Price
Some of the most useful information relevant to CDMO selection is also the hardest to obtain. Here are suggestions for uncovering data that tells the whole capability story.
August 2026 — 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.
ICH M4Q(R2) And M16 Modernize The CTD For Digital Submissions
A former FDA assessor explains how recent changes to the common technical document bring long-overdue updates to the submission process, accounting for greater data demands.
Engineering Better ADCs, Part 1: MoA, Conjugation Chemistry, And More
The field has evolved considerably in antibody–drug conjugate (ADC) science. In this first article of a two-part series, let's discuss how to engineer better ADCs, covering MoA, conjugation chemistry, and more.
Building Sustainable Biopharma Supply Chains Starts With Procurement
Nearly all the industry's emissions happen upstream from core manufacturing functions. This puts sustainability almost entirely on the shoulders of purchasing.
Sustainable Facility Design Brings Bayer Instant Savings
ROI for sustainability initiatives often come later as lower maintenance and utility costs. Bayer's pursuit of LEED certification led to substantial savings up front.
Why You Should Measure Comparability Debt Before Ever Starting A Study
When analytical capability and process understanding fail to keep pace with a drug candidate, the technical uncertainty creates debt that's difficult to pay down.

BIOPROCESSING WHITE PAPERS

Extractables And Leachables Assessment For Single-Use Systems
Efforts to enhance biopharmaceutical manufacturing focus on boosting production capacity sustainably and economically. Explore how optimizing processes with single-use solutions and monitoring leachables ensures product quality.

Comparing In-Line Vs At-Line Variable Pathlength Tech For UF/DF
11/20/2025

Discover how rapid amino acid profiling improves media insight, detects variability, and supports real-time optimization for stronger bioprocess control, as well as strategies to reduce risk.
A Cell Line Development Platform Accelerating Timelines To Clinic
3/20/2026

To support a seamless transition from early clinical studies through to commercial manufacturing, cell line expression systems must be carefully designed and selected based on several critical attributes.
Engineering Reliability In Cell Therapy Manufacturing
2/3/2026

A cell therapy manufacturing model built on precision planning, digital execution, lifecycle‑ready CMC systems, and transparent collaboration to achieve high reliability and reduce variability across programs.
Process Development For Lyophilized Products
10/16/2024

Learn to identify potential product failure points and design robust formulations and processes for lyophilized products backed by solid data.
Maximize Your Laboratory Efficiency
10/20/2025

Gain insight into how labs can boost productivity by reducing downtime, minimizing errors, and increasing walk-away time through real-time insights and analytics.

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BIOPROCESSING APP NOTES & CASE STUDIES

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EDITORIAL COLLECTIONS KNOWLEDGE CENTER

Editorial Collections are subscriber-only, curated resources that combine expert interviews, feature articles, and industry analysis to help readers better understand emerging trends, operational challenges, regulatory developments, and best practices shaping the biopharma industry.

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