Merck

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


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