MilliporeSigma Articles
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Considerations For Bioreactor Process Development And Scale-Up For Transient Transfection-Based Lentivirus Production In Suspension
9/14/2020
Several challenges are associated with use of an adherent platform for lentivirus production. This white paper describes considerations for suspension-based, transient transfection bioreactor process development and scale-up of lentivirus production. We will describe the approach taken for process development.
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Downstream Process Intensification For Virus Purification
9/9/2020
An overview of the challenges presented by current approaches to virus production and a platform approach that can work across different viral modalities and accelerate process development.
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The Race From Lab To Clinic: 5 Critical Steps To Success
6/17/2020
While the fastest path is often tempting, the right path is to ensure product quality and viability while expediting the development timeline. These five steps are key to putting your molecule on the right path.
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Updated US FDA Guidance For The Gene Therapy Industry: Key Changes And Areas Of Increased Focus
6/17/2020
In January 2020, the United States Food and Drug Administration (FDA) released several new or updated guidance documents pertaining to human gene therapy products. This paper summarizes several key changes that will impact developers of gene therapies.
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Risk Mitigation Strategies For Raw And Starting Materials Used In Gene Therapies
5/15/2020
A number of risk mitigation strategies related to the materials used to produce viral vectors can be employed to help accelerate progress towards commercialization of remarkable therapeutics.
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Reducing The Risk During Cell And Gene Therapy Development And Manufacturing
5/13/2020
While these new modalities are generating significant excitement among patients and caregivers, cell and gene therapy manufacturers are experiencing growing pains. The rapid growth and continued momentum of the industry has led to the issuance of new guidance. In this article we share insights for navigating within a novel and complex regulatory environment, mitigating risks posed by raw materials and implementing proper risk assessments during manufacturing.
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Further Adapting New Bioprocess Technology In An Era Of Change
5/8/2020
Biopharma 4.0 is becoming more tangible every day. Catch up on the initiatives and programs that are defining the application of Industry 4.0 principles for MilliporeSigma technologies and services.
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The Future Of MilliporeSigma’s Gene Therapy CDMO Through The Lens Of History
4/27/2020
On the road to becoming a global industry leader in cell and gene therapy, our viral vector manufacturing organization has undergone a major transformation over the last two decades. Marc Gaal, Director of Program Management at MilliporeSigma, details the history of the business as well as some of the milestones achieved since its inception.
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Alternatives To In Vivo Assays For The Biosafety Testing Of Biologics
3/31/2020
Even though alternative methods have emerged, in vivo tests have stubbornly remained a central part of biosafety testing. Here, we examine current in vivo methods and explore modern alternatives.
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Process Monitoring, Data Management For Bioprocess Challenges
2/4/2020
Setting up systems to automatically compile and analyze data routinely, versus compiling it, reduces workloads, provides timely access to critical information, and allows for data-driven decisions.