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Navigating Outsourced Pharmaceutical Testing Through Today's Geopolitical Uncertainty

Geopolitical shocks are reshaping outsourced pharmaceutical testing. Learn how procurement teams can strengthen resilience and protect continuity.

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EDITOR'S DESK

AstraZeneca's Focus On Predictive Control, Semi-Autonomous Processing
This article captures key takeaways from a BioProcess International keynote by Preeya Boppana, director of MSAT process analytics and laboratories at AstraZeneca, titled “Transforming Biologics Manufacturing: Leveraging Predictive Analytics and Advanced Process Control for Next-Generation Operations.”

Prioritizing Quality Over Everything

Regulatory compliance and cGMP manufacturing expert Tatyana Matveeva, Ph.D., explains the role and importance of a quality unit in an organization, as well as what happens when it’s compromised.

Evaluating The Levers Driving Productivity In Bioprocessing

Experts discuss where productivity gains can be achieved and how development teams should seek to improve process performance in this recap of the Bioprocess Online Live event "The Levers And Tradeoffs That Drive Process Productivity."

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.

GUEST COLUMNISTS

The 5 Shifts That Could Remake Lyophilization By 2040
Purdue University-based LyoHUB charts a risk-based course to modernizing freeze-drying technology for better performance and advanced modalities.
Complete Response Letters For CGTs Share This Common Theme
One expert’s analysis found CMC-related concerns in about 75% of complete response letters. He outlines a path to stronger CMC readiness for cell and gene therapies.
Your 7 Decisions To Make Before MES Configuration
Don't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.
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.
Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization.
FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.
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.

BIOPROCESSING WHITE PAPERS

Coordinated Drug Development As An Execution Framework
When clinical research, CMC, manufacturing, and supply operate in silos, every phase transition resets alignment. Here, authors examine what changes when those functions operate within a shared execution framework.

The Importance Of Polymorph Screenings
5/6/2026

Discover how systematic polymorph screening reduces development risk, safeguards product performance, and enables confident solid‑form selection across the drug development lifecycle.
Rethinking Peptones As First-Line Optimization Tools
11/14/2025

Peptones enhance CHO cell growth, viability, and yield, offering a fast, low-risk way to improve bioprocess performance without major process changes.
Isolate Bright GFP-Expressing HEK293 Cells For Cell Line Development Workflow
11/7/2025

Explore a high-efficiency workflow for isolating and expanding GFP-expressing HEK293 cells that enables stable, bright clones ideal for imaging and tracking to simplify clonal development.
Eliminate Variability, Accelerate Results: Value Of Ready-To-Use Reagents
10/15/2026

Pre-made solutions reduce operator variability, save bench time, and lower contamination risk by eliminating reagent preparation and reducing handling.
Life Cycle Assessment Of Extended Use Strategies For Single-Use Assemblies
4/17/2026

Examine how extending the use of single‑use assemblies can significantly reduce emissions, resource consumption, and waste in bioprocessing, offering a data‑backed path toward sustainability.

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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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