The FDA released final guidance on the Advanced Manufacturing Technologies Designation Program at the end of December. This article shares a summary, analysis, and how it compares to the 2023 draft.
- Comparison Of Sterilization Methods: Vaporized Vs. Aerosolized Hydrogen Peroxide
- A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices
- New AAV Reference Standards To Aid CQA Assessment
- New Reference Standards To Support Quality of AAV Raw And Starting Materials
- These Were FDA's Top Citation Issues For Data Quality In 2024
- 2024 Trends In FDA Observations For Sterile Drug Manufacturers
- GlycoNex On Challenges In Biosimilar Development, Manufacturing
EDITOR'S DESK
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Optimism For Biopharma In 2025
In this closing segment from the executive roundtable discussion, our panelists express their confidence in the industry's mission and maintain a positive outlook for the years ahead.
In this segment of the executive roundtable discussion, our panelists weigh in on how to prepare for what may be a challenging financial climate 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.
GUEST COLUMNISTS
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Comparison Of Sterilization Methods: Vaporized Vs. Aerosolized Hydrogen Peroxide
Hydrogen peroxide (H2O2) is one of the most frequently used chemical compounds for sterilization. This article compares the benefits and trade-offs of using the vapor form vs. aerosol form.
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A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices
Human errors account for many manufacturing failures, simply due to the roles in our activities and systems. Relational risk analysis (ReRA) fundamentally changes the way risks are analyzed.
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New AAV Reference Standards To Aid CQA Assessment
AAVs' complexity makes them difficult analytical testing subjects. The second part of a series describes USP's latest effort to help characterize the viral vectors.
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New Reference Standards To Support Quality of AAV Raw And Starting Materials
The United States Pharmacopeia aims to help gene therapy manufacturers address the challenges that come with complex starting materials like endonuclease and plasmids.
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These Were FDA's Top Citation Issues For Data Quality In 2024
Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate procedural controls and poor record-keeping.
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2024 Trends In FDA Observations For Sterile Drug Manufacturers
This data-driven analysis of the 2024 trends in FDA observations for sterile drug manufacturers includes a comparison to the 2023 trends. Which 21 CFR 211 sections surprise you most?
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Top 10 Data Auditor Statistical Software Requests
Statistical analysis provides a backbone for establishing critical process parameters and offers evidence of process validation for regulatory submissions.
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Computer Systems Validation Pitfalls, Part 4: Inattention To Details
The authors conclude their 4-part article series on computer systems validation (CSV) pitfalls using real case studies to illustrate points related to inattention to details.
BIOPROCESSING WHITE PAPERS
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Establishing Analytical Methods For mRNA-Based Therapies
Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.
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Novel Cell Lysis Solution: Scaling Up The Harvest Process5/10/2024
To ensure patient safety — as well as a portable process outside of Europe — it’s time to find a novel reagent without harmful, endocrine-disrupting properties.
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Host Cell Protein Analysis: Immunoassays3/10/2023
Learn about host cell proteins (HCPs) and the sensitive and specific orthogonal methods necessary to identify individual HCP impurities that persist through DS purification processes.
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Designing A Disinfectant Study For Your Cleanroom5/14/2024
Disinfectant efficacy studies are crucial for safeguarding the sterility of your manufacturing facilities. Gain expert insights into the intricacies of these important studies and how to design one.
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Tackling Cell & Gene Therapy Manufacturing Challenges5/30/2024
Allogeneic therapies are gaining popularity due to diversity, scalability, and affordability. A partner with innovative solutions can help streamline the path from discovery to commercialization.
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Revolution In The EU Pharmaceutical Legislation Ahead2/8/2024
Discover the impact revised pharmaceutical legislation will have on the industry by superseding regulations that have fostered the availability of safe and effective medicines for the past two decades.
BIOPROCESSING APP NOTES & CASE STUDIES
- How To Perform Fast And Stable Multicolor Live-Cell Imaging
- Custom Formulation Solution Including An Animal-Origin Element
- Viscosity-Reducing Excipients For Protein Formulation
- Scalable Results 30mL-2L In Optimum Growth® Flasks With ExpiCHO™ Expression System After Transfection
- How A Top 5 Pharma Realized $20M In Annual Savings
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.
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ON-DEMAND WEBINARS
- LBA Vs. LC-MS: Competing Technologies At A Development Crossroad
- The Next Frontier In mRNA: Modular Manufacturing For Scalable RNA-LNP Therapies
- Linking mAb Product Quality Profile Changes To Your BioProcess: A Case Study
- Quality Roundtable: Raw Material Planning For Tech Transfer And Scaling Biologics
- Growing A Sustainability Culture Across An Expanding CDMO Network
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