Bioprocess Online for bioanalytics, biopurification, bioproduction

New Regulatory Survey Findings: Biotech Global Market Access Challenges And Learnings

To understand biotech companies’ evolving geographic strategies and perceptions, Arriello recently commissioned a transatlantic survey among regulatory, safety, and quality directors at small/medium biotechs, with respondents in Ireland and North America.

EDITOR'S DESK

Political Influences And Regulatory Implications For Biotech In 2025
In this segment of the executive roundtable discussion, our panelists discuss the changing political landscape and its potential effects from a regulatory and economic point of view.

2025 Predictions For AI Use In Biotech

In this segment of the executive roundtable discussion, our panelists discuss the growing prevalence of AI and its implications, both good and bad. They share their thoughts on smart adoption and the need for regulatory guidance moving forward.

Cell Therapy Manufacturing Trends And Advancements Continuing In 2025

In this segment of the executive roundtable discussion, our panelists reflect on recent advances in cell therapy manufacturing and discuss active areas of innovation.

Exciting Areas Of Innovation For Cell Therapies

In this segment of the executive roundtable discussion, our panelists express optimism about the promising future of allogeneic cell therapies and discuss other innovations in the field.

ADCs: Leading With The Linker

Leo Marx, Ph.D., the Medicinal Chemistry Project and Bioconjugation Manager at Debiopharm, shares his company's rationale for the company's ADC development decisions and why its linker technology is the tip of the spear for those that make the cut.

GUEST COLUMNISTS

CTMC's 2025 Cell Therapy Manufacturing Outlook
CEO Jason Bock looks back on milestones of 2024, namely an approved TIL for melanoma, and explains how it sets the stage for this year.
Hear Me Out — Cell Therapy GMP Starts With The Donor
Regulators also have indicated they expect allogeneic cell therapy donors to meet more rigid eligibility requirements and undergo screening.
A Justification For Using In-Process Controls In Place Of Cleaning Validation
This article provides a procedure for using and cleaning shared columns and column packing equipment and using in-process controls that eliminate the need for cleaning validation.
7 Focus Areas To Establish A Win-Win Relationship With Your CDMO
Working with a CDMO doesn’t always go as planned. This article outlines the factors that will impact project success and set up a “win-win” relationship.
Deploy AI To Become A cGMP "Special Agent" With A License To Care
Addressing systemic cGMP issues requires more than technical fixes — it demands organizational transformation. Thoughtfully applied, AI can empower professionals to become "special agents" of quality, equipped with a "license to care."
11 Key Contributing Factors For Maintaining Sterility Assurance
Containers and closures, depyrogenation, equipment, materials, personnel, and 7 more major factors all contribute to sterility assurance.
Here's Why The Life Sciences Struggle To Exploit Process Knowledge
Pharma often fails to take full advantage of the vast amounts of data it produces. It could do better with knowledge management embedded as a core business strategy.
December 2024 — 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

Upscaling hMSC Production Enhances Extracellular Vesicle Secretion And Cargo Profile
Explore how the dynamic microenvironment of bioreactors influences the production and composition of extracellular vesicles (EVs), including exosomes, secreted by human mesenchymal stromal cells (hMSCs).

Enhancing CMC Regulatory Efficiency In Gene Therapy
9/30/2024

Ensure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.
Effect Of NK-EVs And Carboplatin On Osimertinib-Resistant Lung Cancer Cells
12/18/2024

Delve into a study that examines the possibility of the combination of NK-cell-derived EVs and CBP as a viable immunochemotherapeutic strategy for resistant cancers.
Successful Planning: Process Liquid & Buffer Preparation
6/23/2023

Obtain an accurate total cost of ownership assessment through understanding common operational inefficiencies, risks, and financial burdens associated with process liquid and buffer preparation.
Assessing Liquid Transfer Performance With Reliable, Ready-To-Use Reagents
11/13/2023

See how specially formulated dye-containing solutions replicate the liquid transfer properties of several commercially available PCR master mixes, making them reliable and ready-to-use reagents for determining liquid transfer performance.
Improve Your Molecular Cloning Process With Synthetic Biology Automation
5/25/2023

Explore the promising field of synthetic biology, the hurdles manufacturers face with it's workflow, and how automation can help accelerating throughput and walkaway time.

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BIOPROCESSING APP NOTES & CASE STUDIES

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BIOPROCESS ONLINE CONTENT COLLECTIONS

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This collection of articles, produced through a partnership between MilliporeSigma and Bioprocess Online, highlights the need for ongoing investment in resilient biomanufacturing capacity and supply chains to ensure the reliable delivery of health technologies like vaccines, even during crisis conditions.