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Viral Vector Formulation, Final Filtration and Filling

Formulation graphic representing downstream gene therapy processing

Formulation, final filtration, and filling are the last steps in viral vector production. A rational formulation design developed by optimizing solution conditions and high-quality excipients can significantly increase viral vector stability and shelf-life. Our wide range of high-quality buffers, salts and stabilizers, low in bioburden and endotoxins, are specifically developed for high-risk applications and can ensure successful downstream processing and formulation of your final gene therapy product.

Designing a successful single-use sterile filtration system should focus on maximizing the recovery of these high-value therapies and consider different filter options, process requirements, sampling needs, and if pre-use post-sterilization integrity testing (PUPSIT) will be performed.

Our Mobius® single-use assemblies offer you flexibility and our specialists can help you design a custom assembly from our broad portfolio of filters and single-use components. These systems are scalable and can be easily replicated to meet your evolving needs.

Supported by our Emprove® program, our excipients, filters and single-use components have extensive documentation, minimizing regulatory and quality-associated risks in your manufacturing. All this simplifies the complexity of your supplier qualification and speeds up processes, thus reducing the total cost of ownership.

  • A broad excipient portfolio, manufactured according to the IPES PQG GMP guidelines
  • Sterilizing-grade filters for viral vector purification
  • Mobius® single-use assemblies for viral vector purification
  • Validation services to confirm your single-use filtration system is suitable for processing

Related Product Resources

Brochure: Your Fast Track Through Regulatory Challenges – The Emprove® Program
White Paper: Identifying Appropriate-Quality Raw Materials in an Evolving Regulatory Environment
Brochure: Pharma Raw and Starting Materials - Satisfy your regulatory requirements
Brochure: Emprove® Filters and Single-Use Components

Workflow

Gene Therapy Manufacturing

Gene Therapy Manufacturing

The rise of gene therapies is driving rapid innovation, but manufacturers face complex challenges bringing new therapies to life

Viral Vector Upstream Processing

Making the right upstream process decisions not only impacts viral vector titer, but downstream processes, timelines, and regulatory acceptance

Viral Vector Downstream Processing

Efficient virus purification processes can improve yield, decrease time to patient, and lower manufacturing costs

Viral Vector Characterization and Biosafety Testing

Critical biosafety testing and characterization of viral vector products can help to fully analyze key quality attributes: identity, potency, safety, and stability

Viral Vector Contract Development and Manufacturing

CDMO partnerships play a critical role in advancing clinical pipelines and achieving successful commercialization

Related Products

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  • Millipak® Final Fill Filters

    Millipak® Final Fill Filters

    Millipak® Final Fill capsules are designed for reliable sterile filtration of small volume, high value solutions. 

  • Durapore® 0.22 µm Capsules

    Durapore® 0.22 µm Capsule Filters

    Durapore® sterilizing-grade 0.22 µm hydrophilic polyvinylidene fluoride (PVDF) membranes are low protein binding and provide sterility assurance, high flow rates and throughputs.

  • Formulation

    Formulation

    Our broad range of GMP products covers pharmaceutical raw materials for the development and manufacturing of solid, semi-solid and liquid dosage forms for small and large molecules. 

Related Applications
Viral Vector Downstream Processing
Demand for new gene therapies is challenging manufacturers to accelerate development. By replacing legacy purification technologies with more scalable alternatives, downstream operations can produce greater economies while delivering higher yield and throughput.
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Introducing a new cell therapy demands optimal performance in upstream and downstream processing, process development, testing, and manufacturing. World-class products and partners are critical to success, speeding advancement of therapeutics that are effective, safe, and affordable.
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Emprove® Program
Confidently speed your way through the regulatory maze and fast track your new drug to market with the Emprove® Program. High-quality products, comprehensive documentation, and superior customer support facilitate your efforts in qualification, risk assessment, and process optimization.
Emprove® Chemicals
To simplify raw material selection while satisfying regulatory requirements, our Emprove® Chemicals portfolio contains over 400 pharmaceutical raw materials offering the comprehensive, up-to-date documentation you need to navigate regulatory challenges, manage risks, and improve processes.
Emprove® Filters and Single-Use Components
Answering industry-wide demand for increased transparency, our Emprove® Filter and Single-use Components portfolio helps biopharmaceutical manufacturers advance their product development with confidence.
Single-Use and Filter Validation Services
Accelerate and simplify your path to market by using our BioReliance® Validation Services to select, test, and validate your filters, assemblies, and single-use systems for drug manufacturing and processing.
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From first-in-human clinical trials to scaling up for commercial launch, our final product release testing for cell and gene therapy provides the geographic footprint, experience, and expertise to bring your therapy to patients.

Related Webinars

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