Home Gene Therapy

Gene Therapy

FUJIFILM Diosynth Biotechnologies is a world-leader in the delivery of microbial, mammalian and viral therapeutics and a global service provider in gene therapy and vaccine production.

Let us be your CDMO partner for life – from pre-clinical, clinical and all the way up to cGMP compliant manufacturing and commercialization. Our services include process development, analytical development and cGMP production.

A gene therapy CDMO partner for life

We have an established team of virologists with deep understanding of viral vectors and virus replication platforms – and extensive experience in the scale-up and GMP production of viral products.

Let us be your CDMO partner for life – from pre-clinical, clinical and all the way up to cGMP compliant manufacturing and commercialization. Our services include process development, analytical development and cGMP production.

Whether you are working to add genes that permit the immune system to recognize diseases, replace mutated genes, or fix them by turning them on or off – we have a solution.

Process development for successful gene therapies
Robust and Reliable

Process Development

To successfully manufacture gene therapy and viral vaccine products, your process needs to be cGMP ready by design.

Learn more

Viral vaccines image
High-Quality Expression

Analytical Development

Our analytical team specializes in the development of assays to verify high-quality expression of therapeutics and viral vectors – and support effective cGMP production.

Learn more

Cgmp-production cells
Effective and reliable

Gene therapy and viral products cGMP production

As a leading CDMO with world-class cGMP compliant facilities, we offer effective and reliable production of gene therapies and vaccines.

Learn more

Gene therapy, viral technology and vaccine production

Gene therapy has the potential to provide more effective treatments and vaccines for a variety of diseases, including cancers, diabetes, hemophilia and AIDS. In addition, gene therapy is particularly relevant in the treatment of rare diseases, because approximately 80% of these orphan diseases are caused by a single gene (monogenic). Several successful clinical studies on viral vector-based gene therapies have been conducted – and an ever-increasing number of products are now entering late-phase clinical trials with the potential of becoming new licensed therapies.

The importance of having a robust and scalable manufacturing process cannot be over emphasized – and this work has to start early for your program to be successful. This is because there are several barriers on the way to commercialization, including finding a good host / virus combination, developing a reliable and efficient process, and then scaling-up that process up for cGMP production.

Our unique experience and capabilities

Deep understanding of gene therapy, vectors and viral technology

Recombinant technologies

  • Expertise and experience in rDNA technologies including transfection, cloning / gene insertion and transduction

Virus technology

  • An established team of virologists with deep understanding of viral vectors and virus replication platforms, provides your program great capabilities in vectors and virus technology.
  • Experience with multiple viruses and virus vectors (attenuated, recombinant)
  • Generating RVB, MVB,WVB
  • Virus titer or genome copy number and total particles determined by orthogonal methods
  • Plaque purification
  • Virus engineering: purification, inactivation, adaptation to cell lines

Did you know?

That while adeno-associated virus (AAV), adenovirus and lentivirus are some of the most commonly used vectors, Poxvirus and Baculovirus also show great promise? Learn more about the vectors we use at FUJIFILM Diosynth Biotechnologies.

What’s the difference between working with rProteins and Virus/Cells?

There are many considerations to take into account when working with virus/cells as target products instead of recombinant proteins. Virus and cells are alive. The product can be sensitive to chemical attack. Care needs to be taken with agent control. And there are many product challenges like access, format, isolation etc.

Want to learn more about how we at FUJIFILM Diosynth Biotechnologies use our experience to overcome these challenges?