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Suffering High Protein Sieving Losses? It Might Be The Buffer

New research shows that a common buffer used during diafiltration and ultrafiltration was at the heart of sieving losses, and using an alternative dramatically improved retention.

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

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.
Host Cell DNA Impurities: A Unique Challenge For rAAV
The potential safety impact of residual hcDNA remains largely unknown, but researchers at UCB are investigating to learn more and mitigate if necessary.
Tune Therapeutics' 2025 Epigenome Editing Outlook
Chief Scientific Officer Derek Jantz talks about recent key innovations in gene therapy and RNA technology while considering what milestones we might see in 2025.
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."

BIOPROCESSING WHITE PAPERS

The Importance Of Quality In Raw Material Selection
Learn how to select high-quality raw materials for cell-based manufacturing in this exploration of the criticality of raw materials, from preclinical development to commercialization.

PEG In LNP Formulations: Addressing Challenges And Seeking Solutions
2/8/2024

Polyethylene glycol and similar variants have driven innovative research for therapies. However, the continued use of PEG poses significant drawbacks.
Microbial Challenge In-Use Studies
6/13/2024

Learn more about how a partner with expertise can help you navigate the complex landscape of microbial challenge in-use studies and ensure the highest standards of patient care.
Development And Regulation Of Veterinary Monoclonals
2/8/2024

Although veterinary mAbs have achieved commercial success, ongoing discussions and clinical developments surrounding them are expected to outline a clear regulatory pathway in the near future.
Extractables And Leachables Testing
4/9/2024

Learn how to navigate the extractables and leachables regulatory landscape and implement best practices for leachables analysis in your pharmaceutical development process.
Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars
2/9/2024

The presence of ADAs can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.

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BIOPROCESSING APP NOTES & CASE STUDIES

More Bioprocessing App Notes & Case Studies

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.