MilliporeSigma

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 Technical Resources



Workflow

An illustration depicting a healthcare professional in a white coat, presenting a large pink molecule model to a family of three.

Gene Therapy Manufacturing

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

A simplistic purple line drawing of a stylized robot with a rectangular body, two legs, and an antenna on top.

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

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

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

A purple outline of a magnifying glass zooming in on a circuit-like pattern, symbolizing analysis or inspection of technology.

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



Related Products

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.



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