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.
- New Regulatory Survey Findings: Biotech Global Market Access Challenges And Learnings
- Host Cell DNA Impurities: A Unique Challenge For rAAV
- Tune Therapeutics' 2025 Epigenome Editing Outlook
- CTMC's 2025 Cell Therapy Manufacturing Outlook
- Hear Me Out — Cell Therapy GMP Starts With The Donor
- A Justification For Using In-Process Controls In Place Of Cleaning Validation
- 7 Focus Areas To Establish A Win-Win Relationship With Your CDMO
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.
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.
In this segment of the executive roundtable discussion, our panelists reflect on recent advances in cell therapy manufacturing and discuss active areas of innovation.
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.
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 Solutions2/8/2024
Polyethylene glycol and similar variants have driven innovative research for therapies. However, the continued use of PEG poses significant drawbacks.
-
Microbial Challenge In-Use Studies6/13/2024
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 Monoclonals2/8/2024
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 Testing4/9/2024
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 Biosimilars2/9/2024
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.
BIOPROCESSING APP NOTES & CASE STUDIES
- Evaluating On-Target/Off-Tumor Effects Of Cancer Immunotherapies
- Analyze Raw Materials to Improve Product Quality
- Comprehensive Pathway To Seamless Scale-Up Of mRNA DP Manufacturing
- Using A Multichannel Verification System To Measure Residual Volumes
- Overcoming Bispecific Antibody Purification Challenges
BIOPROCESS ONLINE CONTENT COLLECTIONS
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.
More Content CollectionsFEATURED PRODUCTS AND SERVICES
ON-DEMAND WEBINARS
- Growing A Sustainability Culture Across An Expanding CDMO Network
- Revolutionizing Bioanalysis: Harnessing AI For Enhanced Precision, Insights, And Efficiency
- Making MSCs GMP: A Compliant Workflow
- Exploring New And Improved Analytical Methods For Traditional And Unique Modalities
- Nitrosamines - New Requirements To Evaluate Contamination Risks
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 01.20.25 -- Leveraging Directed Evolution To Optimize AAV Vector Design
- 01.17.25 -- STREAM Edition: Revolutionizing Bioanalysis: Harnessing AI For Enhanced Precision, Insights, And Efficiency
- 01.17.25 -- Cell Therapy Manufacturing Trends And Advancements Continuing In 2025
- 01.16.25 -- Contamination Control: The Key To Cleanroom Compliance
- 01.16.25 -- Engaging A CDMO Partner With Life Biosciences' Jerry McLaughlin