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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.

We can provide development, analytical, and manufacturing solutions for all of your recombinant vaccine and gene therapy needs.

Process development for successful gene therapies
Robust and Reliable

Process Development

We build robust and scalable manufacturing processes by incorporating critical design parameters necessary for cGMP compliance and success.

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High-Quality Expression

Analytical Development

Our analytical teams specialize in the development, qualification, and validation of assays to test and verify critical quality attributes of your product.

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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.

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Gene therapy, viral technology and vaccine production

Recombinant DNA technology has paved the way for development of gene therapy as a potential long-lasting therapeutic option for several genetic diseases and for development of recombinant vaccines for emerging and reemerging 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). Hundreds of 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 rcombinant DNA technologies including transfection, transduction, and cloning

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 working with multiple viruses and viral vectors
  • 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
  • Process residuals and impurity testing