Home Viral Vector and Vaccine Services Process development for viral vectors and recombinant vaccines
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Process development for viral vectors and recombinant vaccines

FUJIFILM Diosynth Biotechnologies’ critical strengths include our technical teams who are experienced in overcoming scale-up challenges to develop scalable GMP compliant processes, and our state-of-the-art facilities for the production of cGMP drug substance and drug product. Our development-to-manufacture approach retains flexibility to incorporate process optimization to improve your product’s safety, efficacy and stability attributes.

From the very beginning, our aim is to develop a robust and reliable large-scale manufacturing process.

To successfully manufacture viral vector and vaccine products, your process needs to be cGMP-ready by design. Process development involves several challenges, including optimizing the upstream/ downstream processes and performing process scale-up, to be able to manufacture products having the required product quality attributes.

We strive to address these challenges through concerted efforts, utilizing our experience and foresight to identify areas of greatest risk well ahead of cGMP manufacture. In the event that any challenges arise, our teams are always able to work together, with our clients, to achieve the best possible outcome.

Viral vectors

Our experts have broad experience in handling BSL-2/BSL-3 viruses and routinely work with a variety of viral vectors including:

  • Several serotypes of Adenovirus and recombinant Adenoviral vectors
  • Several serotypes of recombinant Adeno-Associated Virus (AAV)
  • Recombinant Lentiviral vectors
  • Poxvirus
  • Baculovirus
  • Influenza virus
  • Herpes simplex virus

Upstream process development

FUJIFILM Diosynth Biotechnologies’ upstream process development capabilities include adherent and suspension cell culture platforms. Our development facilities are designed to run small-scale campaigns ahead of large-scale cGMP manufacture in adherent (HYPERStack/CellSTACK) or suspension (10-50L) Xcellerex bioreactors. We have developed and optimized many products in a variety of mammalian and insect cells including HEK293, Vero, CHO, HeLa, A549, Sf9, Sf21 and others.

VIRAL VECTOR EXPRESSION SYSTEMS

FUJIFILM Diosynth Biotechnologies is a global leader in the development and cGMP manufacture of processes using viral vector expression systems to support early and late phase clinical programs associated with gene therapy and gene-modified cell therapy.

Image of virus

DOWNSTREAM PROCESS DEVELOPMENT

One of the major steps in development of an optimal, scalable and cost effective production process is identifying and establishing an appropriate downstream process. Delays in optimization and establishment of ideal purification strategies not only add to the product development costs but can also significantly delay commercialization of the products.

There is really no generic solution to purification, because different vectors present different purification challenges. A deep understanding of the properties of the specific vector is critical, because characteristics like stability and isoelectric point will determine the optimal parameters and conditions. To minimize the number of steps in the purification of your specific biopharmaceutical and achieve maximum yield, you will need an experienced team. We can be your partner.

Commonly used downstream capabilities include:

  • Clarification, depth filtration
  • Tangential flow filtration
  • Chromatographic purification
  • Final formulation
  • Sterile filtration
  • Viral inactivation techniques
  • Viral clearance support