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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.

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EDITOR'S DESK

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.

BIO 2026: Crowley On Competing With China And Modernizing The FDA

Exclusive coverage from John Crowley's press conference at the 2026 BIO International Convention in San Diego.

Essential CMC Elements For A Therapeutic Secretome

Noveome Biotherapeutics's Larry Brown, Sc.D., explains the regulatory and CMC challenges behind the company's novel secretome therapy, ST266.

GUEST COLUMNISTS

You Can't CAPA What You Can't Classify
An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.
6 Modeling Approaches That Make Complex Bioprocess Data Useful
AI algorithms can reduce data dimensionality more faithfully by interpreting multivariate features relevant to prediction or control.
Bringing Next-Gen Sequencing To GMP Scale
NGS enables broad detection of known and novel viruses in a single assay. Its high sensitivity, specificity, and scalability can meet GMP throughput levels.
Risk Managing Through The Void Of ATMP Visible Particle Guidance
Regulators expect cell therapy manufacturers to prove they control for visible particles, but guidance remains notably quiet on the matter. Companies must get creative or risk clinical holds.
Building Trust In AI For Computerized System Validation
Using AI for CSV might feel like the students are grading their own papers. One consultant explains why it's not the same, namely, there are no subjective judgment calls.
A Gentler Cell Line Selection Method Using microRNA
Traditional selection stresses surviving cells. New research shows how structurally interacting RNA may use endogenous microRNA for a faster, nontoxic selection process.
When To Trust And When To Verify AI-Enabled Validation Systems
Computer software assurance, coupled with AI, can help validation teams reduce redundant work and spend more time on patient-centric issues.
CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture
Discover strategies for risk-based governance, AI-enabled quality management, stronger collaboration, and fostering a culture that supports long-term operational excellence.

BIOPROCESSING WHITE PAPERS

Late‑Stage Progress In Excipients For Precision Nanomedicine
View late‑stage development and GMP manufacturing of novel excipients for nanomedicines, emphasizing regulatory rigor, process optimization, analytics, and scale‑up for lipid‑based delivery systems.

A Journey To Produce MSC-Derived Cell Therapies From Isolation To Large-Scale
2/26/2026

Drive successful MSC therapy development by optimizing isolation methods, surface chemistry, and closed-system expansion technologies to ensure cellular stability and commercial scalability.
Leak Rate Testing for Freeze Dryers: A Scientific Approach
10/16/2024

Explore our innovative approach to establishing leak rate acceptance criteria and ensure the integrity of your freeze-drying processes for sterile pharmaceutical production.
Why Get Cleaning Validation Support From The Cleaner Supplier?
6/22/2026

Standardize compliant cleaning by integrating risk-based validation, effective residue detection, and science-based limits to reduce cross-contamination and protect product quality.
Three Key Strategies To Guide Efficient And Effective Recall Management
2/18/2025

Discover how to successfully navigate recalls with a digital approach that helps achieve effective recall management, communication, and continuous improvement for brand integrity.
Optimizing Bioprocess Design And Workflow Orchestration
7/30/2026

Disconnected systems can slow development by making data harder to coordinate. Learn how workflow orchestration and structured experimental design can help labs reduce friction and improve efficiency.

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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.