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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.

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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

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.
Using Digital Platforms To Find Your CDMO
In recent years, digital platforms have emerged to help pharma/biotech companies discover, evaluate, and connect with CDMOs more efficiently. These resources have different functions and limitations.
A QMS That Anticipates Cell And Gene Therapy Quality Challenges
Some quality system elements are non-negotiable in Phase 1 cell and gene therapy. For the rest, a risk matrix can help define flexible, defensible specifications.
Controls For Retrieval-Augmented Generation In GxP
Validation teams deal with inherent variability all the time. The same principles for GMP — think visual inspection — can apply to probabilistic AI systems.
July 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.

BIOPROCESSING WHITE PAPERS

Stabilizing Your Supply Chain In Times Of Global Volatility
Discover how a proactive, risk-based supply chain strategy can help strengthen resilience, mitigate disruption, and ensure continuity across your biotech and pharmaceutical operations.

Accelerate Lead Times Through Seamless External Collaboration In Quality
5/21/2026

As CDMO networks expand, disconnected quality processes create delays and risk. Learn how seamless external collaboration improves visibility, accelerates approvals, and strengthens sponsor–partner relationships—helping teams move faster without compromising compliance.
Biomanufacturing Readiness: A Validation Model For Multiproduct Facilities
6/12/2025

Optimize your validation strategy to meet evolving regulatory demands and product complexities with a scalable, efficient framework that accelerates facility readiness and ensures consistent quality.
From Process Monitoring To Manufacturing Intelligence: Real-Time Analytics And Predictive Control In Biomanufacturing
6/19/2026

Advanced analytics, predictive modeling, explainable AI, and digital twins are helping biomanufacturers improve process visibility, anticipate outcomes, and support smarter operational decisions.
FIH: Reach Milestones Sooner With A Technology-Driven Approach
2/12/2026

Accelerate your path to IND and FiH with AI-driven design, advanced cell line engineering, and intensified processes delivering high titers in 9–14 months.
Vial Breakage During Lyophilization: Root Causes And Mitigation
10/16/2024

Learn how controlling freezing rates, using specialized vials, and employing optimized stoppering techniques can reduce the risk of vial breakage during lyophilization and ensure high product quality.

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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.