Gene dna diagram

Gene Therapy

  • Female scientist looking through a microscope

    Gene therapy clarification

    • Gene therapy presents some of the most anticipated opportunities for emerging drugs. With the help of these specialised 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.

       

      Learn how we can help


Reimagine harvest and push the boundaries of clarification with anion-exchange (AEX) fiber chromatography

Graphic illustrating the steps from AAV Lysate to Sterilizing Filter
  • 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.​


Which technology is right for your process?

  • Technology Platforms

    • Quaternary amine (Q) functionalized polypropylene nonwoven
    • 0.2 μm polyether sulfone (PES) membrane

    Mechanism

    AEX

    Materials

    Synthetic

    Feed Stream

    Direct harvest

    Scalability

    Linear scalability from lab to multi-capsule commercial production

    Applications

    • Direct harvest in a single stage
    • Replacement of primary, secondary and guard filters

    Features

    • High mAb product recovery (Capsules: >95%; Conical Tube and Well Plate >90%)
    • Consistent cell loading capacity
    • Turbidity reduction (<15NTU)
    • DNA reduction (<500 ppb)
    • Cell shear minimization
    • 0.1 & 0.2 μm sterile filter protection
    More product details: 3M™ Harvest RC Chromatographic Clarifier
  • Technology Platforms

    • Quaternary amine (Q) functionalized polypropylene nonwoven
    • Highly asymmetric 0.2 μm polyamide membrane

    Mechanism

    AEX

    Materials

    Synthetic

    Feed Stream

    Post depth filter, post centrifuge

    Scalability

    Linear scalability from lab to multi-capsule commercial production

    Applications

    • Replacement of secondary depth filters in harvest and clarification
    • Guard filter to Protein A
    • Bioburden control

    Features

    • Nominal 20-40% HCP and greater than 4 logs DNA reduction
    • Consistent output turbidity (<5NTU)
    • Typically, ≥ 4 LRV endotoxin reduction at low conductivity and neutral pH depending on buffer
    More product details: 3M™ Emphaze™ AEX Hybrid Purifier

Experience 3M innovation from lab to production scale

From lab scale to 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.

  • Photo of lab scale chromatographic clarifier products
    Discovery phase solutions

    Start your discovery process with lab scale solutions that enable you to do your job in less time with less complexity.

  • Photo of production scale chromatographic clarifier products
    Production scale solutions
    Advance from lab to production scale with the 3M™ Harvest RC Chromatographic Clarifier portfolio of lab and manufacturing capsules.

A collection of 3M™ Zeta Plus™ Encapsulated System Filter Capsules in various sizes
3M™ Zeta Plus™ Encapsulated System Filter Capsules
  • 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.


Photo of encapsulated depth filtration product types.
  • 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.​

    Learn More


Global engineering, delivered by specialists

  • 3M employees posing for a group photo

    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.


Ask an expert

Fill out this form for any technical, business or process-related question, and an appropriate 3M Biopharmaceutical representative will contact you to answer your question or direct your request. ​


Webinar - Emerging trends and challenges in cell and gene therapy

View this webinar to learn about the history and pipeline, the state-of-the-art in bioprocessing, what needs to be addressed to overcome process development and manufacturing challenges, and what the future holds for cell and gene therapies.

Watch the webinar Emerging Trends and Challenges in Cell and Gene Therapy

Find more information at 3M School of Purification

Explore solutions

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Explore other applications

  • 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.​

  • 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.

  • 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.​

  • 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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