MilliporeSigma Articles
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Regulatory Considerations For Alternative Microbial Methods
2/28/2022
We discuss regulatory expectations for the incorporation of alternative methods to prevent, remove, and detect contaminants focusing on comparability and strategies for easier substitution of current methods.
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The Impact Of Facility Design On The Safety Of Viral Vectors
2/18/2022
It is critical to vet not just the expertise available at a CDMO, but also the effectiveness of their facility design to reduce risk and meet scale-up needs.
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Envisioning The Future Of Analytical Development For Gene Therapies
10/13/2021
Explore how safety and characterization testing of viral vector production differs from that of other biologics and how novel analytical approaches are being tailored to these advanced therapeutics.
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Implementation Of Rapid Test Methods In Cell And Gene Therapy Testing
10/12/2021
Rapid testing methods for sterility, mycoplasma, and replication competent lentivirus of cell and gene therapies can help address critical issues within this rapidly growing area of the market.
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Facilitating 21 CFR Part 11 Compliance With Bioprocessing Automation Software
8/16/2021
How Bio4C Orchestrator™ software provides technology to support requirements for electronic records and provides a detailed “rule-by-rule” analysis for 21 CFR Part 11 and Annex 11 in tabular form.
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Addressing The Challenge Of Scalability In Viral Vectors
8/10/2021
Learn more about a wide range of solutions to facilitate the delivery of gene therapy by addressing the challenges related to viral vector manufacture and scale-up.
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Optimized Cell Culture Medium For Scalable Viral Vector Production
7/20/2021
MilliporeSigma’s new cell culture medium offers an improved alternative to classical formulations that can help address the constraints in viral vector manufacturing and scale-up.
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Beyond 2020: Looking Into The Crystal Ball For Gene Therapy
3/25/2021
Mirror mirror on the wall, what is the promise that Gene Therapy holds for all? The urgency, uniqueness, and uncertainty surrounding gene therapy manufacturing creates many challenges. Let us take a look into the crystal ball of gene therapy to address unanswered questions and plan for what’s next.
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Bio4C ProcessPad™ 21 CFR Part 11 Compliance
1/12/2021
Learn how Bio4C ProcessPad™ meets 21 CFR Part 11 requirements including unique usernames and passwords, timestamped audit trails, and secure storage of all records.
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Leveraging The 4 Cs To Deliver Bioprocessing 4.0
10/7/2020
This article explains the 4 Cs of Biopharma 4.0 - the software, automation and analytics tools that allow Control of unit operations, Connection across the process, Collection of data, and Collaboration such as remote support and cloud services.