- Overview
- PRODUCTS
- 3M™ Emphaze™ AEX Hybrid Purifier
- 3M™ Harvest RC Chromatographic Clarifier
- 3M™ Polisher ST
- 3M™ Zeta Plus Depth Filters
- 3M™ LifeASSURE™ Filters
- 3M™ Encapsulated System Holders
- View All Products
- Solutions
- Harvest and Clarification Solutions
- Fiber Chromatographic Clarification Solutions
- Purification and Contaminant Removal Solutions
- View All Solutions
- Applications
- mAb and Recombinant Protein Manufacturing
- Plasma Fractionation
- Gene Therapy
- Vaccines
- Chemical Pharmaceuticals
- Education
- Support
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Gene Therapy
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Gene therapy clarification
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Gene therapy presents some of the most anticipated opportunities for emerging drugs. With the help of these specialized medicines, the patient's body is converted into an agent to help fight diseases - ranging from cancers to central nervous system disorders and musculoskeletal conditions.
Adeno-associated viruses (AAVs) are often used to deliver genetic materials to target cells to treat or prevent inherited genetic disorders such as hemophilia A or sickle cell anemia. As industry’s understanding of cell biology has improved, vector-directed gene therapy has emerged as an important future drug modality, similar to the adoption of recombinant proteins in the early 2000s.
Gene therapy drugs using AAV are made in bioreactors in cells such as human embryonic (HEK) cells, similar to how recombinant protein therapies are made. 3M biopharma filtration and purification products can potentially be used in the manufacturing processes of gene therapy drugs using AAV as viral vector.
Our Bioprocessing Application Specialists can guide you through manufacturing challenges and bottlenecks to develop efficient processes from pre-clinical to commercial scales.
Webinar - Emerging trends and challenges in cell and gene therapy
Watch our on-demand webinar to gain insight on how to overcome process development and manufacturing challenges.
In this webinar, we cover:
- Cell and gene therapy trends to help overcome challenges and bottlenecks
- How to overcome process development and manufacturing challenges
- A case study on how chromatographic clarifiers can provide solutions in the gene therapy process
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Clarification is a critical unit operation in the production of biologics because it directly affects yield, product consistency and performance of downstream unit operations. 3M created a novel clarification method by filtering with charge rather than by particle size. The media is designed with a synthetic nonwoven material containing quaternary amine grafted fibers, which can remove more impurities than traditional depth filters.
Large contaminants such as cells and cell debris, plus small insoluble and soluble impurities like DNA and HCP, can be removed at this early stage. Enabling higher purity earlier in the clarification steps makes the following downstream processing easier.
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Filtering with charge rather than particle size
Viewed with a scanning electron microscopy (SEM), cells can be seen adsorbed and captured throughout the matrix of the functional nonwoven bed of 3M™ Harvest RC Chromatographic Clarifier.
3M™ Harvest RC Chromatographic Clarifier
Technology Platforms
- Quaternary amine (Q) functionalized polypropylene nonwoven
- 0.2 μm polyether sulfone (PES) membrane
Mechanism
- AEX
Materials
- Synthetic
Feed Stream
- Direct harvest
Experience 3M innovation from lab to production scale
From lab scale to commercial manufacturing, we can help streamline and accelerate your workflow with the entire 3M™ Harvest RC Chromatographic Clarifier portfolio of innovative solutions that enable you to condense steps and improve process efficiencies.
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Discovery phase solutionsStart your discovery process with lab scale solutions that enable you to do your job in less time with less complexity.
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Production scale solutionsAdvance from lab to production scale with the 3M™ Harvest RC Chromatographic Clarifier portfolio of lab and manufacturing capsules.
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Depth filters use fibrous filtration media to retain particles throughout the media, rather than just on the media surface. They are commonly used when process fluid contains a high particle load because, relative to other types of filters, they can retain a large mass of particles before becoming clogged.
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Depth filtration has been the most prevalent single-use clarification technology in many biopharmaceutical manufacturing processes. 3M offers easy-to-handle depth filter solutions in a variety of nominal pore sizes and media characteristics to fit your process needs.
Global engineering, delivered by specialists
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3M’s Bioprocessing Application Specialists can provide guidance to navigate process challenges and resolve inefficiencies to achieve commercial scale. They can identify a common platform that scales from lab to full production and look for opportunities for process intensification — removing unnecessary steps, combining several steps into one and increasing throughput and capacity.
3M is leveraging its current product portfolio to design AAV clarification processes today while developing innovative solutions to enable the AAV clarification processes of tomorrow. Contact 3M to learn how we can support your current needs.
Scale with confidence.
Scalable lab devices are an easy way to test new technology with minimal commitment. Our scalable lab devices work across the process train with linear, scalable results – helping you and your team simplify your development process.
Explore applications
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One step can transform your mAb and recombinant protein manufacturing process. At 3M, we’re helping build better, more efficient and simpler manufacturing processes by developing solutions to enhance biologic drug recovery that leads to improved process economics.
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Plasma fractionation has existed for decades, but additional separation methods are becoming increasingly common. We offer a range of products to help you with your process.
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Getting the most out of your manufacturing process with speed and on budget is an increasing challenge. Our solutions may help you develop manufacturing processes for vaccines to help maximize purity, leading to overall process economics.
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If you need solutions for catalyst removal and recovery, color removal, particulate filtration and fill-finish, 3M offers a wide range of adsorptive depth filters and membrane products for application in the chemical pharmaceutical manufacturing.
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