Bioprocess Online for bioanalytics, biopurification, bioproduction

On The Ground At BPI: Tatyana Matveeva, Ph.D., On Distributed Manufacturing Models

Bioprocess Online caught up with Tatyana Matveeva, Ph.D., at the 2026 BioProcess International conference to discuss her panel session on distributed manufacturing.

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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

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.
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.

BIOPROCESSING WHITE PAPERS

Where Speed Meets Complexity In Bioprocess Development
Bioprocessing faces mounting pressure to compress timelines, especially for mAbs, while complex modalities like bispecifics and gene therapies introduce technical challenges. Process intensification, scale-up translation, and comparability risks remain critical hurdles.

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.
Single-use Mixing Systems For Protein Products: Dissolution And Mechanical Stress
10/14/2026

Mixer design and fill volume shape both how well a solution homogenizes and how much mechanical stress a protein experiences. Impeller configurations are compared against a conventional stirrer.
Leveraging Digitalization To Resolve CGT Manufacturing Challenges
2/12/2025

Uncover digitalization's role in overcoming manufacturing challenges in cell and gene therapies to enhance efficiency, quality, and scalability through data analytics and real-time monitoring.
Leveraging The Immunological Diversity Of The Pentamice® Platform For Covid-19 Antibody Discovery
2/4/2026

Consider this alternative immunization approach — the PentaMice platform, a collection of five wildtype mouse strains bred in-house for increased MHC class II diversity — and how we're leveraging it for COVID-19 antibody discovery.
A Guide To Accelerating Cell Line Development For Commercial Production
7/11/2025

Explore the challenges associated with cell line development in the production of biologics, and solutions that can help biotech developers evade the pitfalls of misinformed decision-making.

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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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