By exploiting the way viruses hijack cell machinery to express viral genes, viral vector gene therapy can introduce therapeutic payloads into human cells to treat previously incurable diseases.
To deliver high quality products at a commercial scale, developers need robust, scalable manufacturing processes and analytical technologies.
Access to GMP manufacturing capacity is also critical in meeting clinical and commercial demand as it increases during the product development lifecycle.

Process development excellence

With our highly tailored, step-by-step approach to commercial readiness, you can be sure of a robust, reproducible and commercially viable Good Manufacturing Practice (GMP) process, de-risking your path to successful commercialization.

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Regulatory support dedicated to cell & gene therapy

Rely on a dedicated regulatory partner for the expertise and experience you need to de-risk your therapy's pathway.

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Viral vector process development from concept to patient


With more than 20 years of experience in manufacturing viral gene therapy products across various vector types, our team of scientists have in-depth technical expertise and comprehensive understanding to design and develop phase-appropriate, commercially viable manufacturing processes.

Our step-by-step process and analytical development approaches are focused on helping you to de-risk your path to the clinic and towards the commercialization of your therapy.

While we run your process, we'll perform manufacturability assessment studies in parallel, to enable you to establish a detailed roadmap and efficiently reach your development milestones on time and without sacrificing future requirements for a commercially viable process.

Our subsequent process optimization and development studies are based on defining manufacturing design specifications and critical quality attributes to allow you to establish a robust CMC package to support your regulatory filings.

Upon completion of your process development studies, our process development scientists work in close collaboration with Manufacturing Science And Technologies (MSAT) teams to ensure a successful process delivery into GMP manufacturing, to support both clinical and commercial products.

Our in-house bioanalytical assay development group is highly experienced in developing and optimizing in-process and final product release testing, including cell-based functional and potency assays to meet your needs.


A home with room to grow


Our 300,000 square-feet dedicated cell and gene therapy facility in Houston, Texas is designed by experts in cell and gene therapy to address the key challenges in the manufacturing of these therapies and the critical product supply needs of our customers.

The modular designed cleanroom can be custom built to fit our client process needs in the existing shell space with a cost-effective and time-efficient manner. By working side-by-side with our clients in the product development life-cycle, we are de-risking your path to commercialization together, from developing regulatory-compliant industrialized process to securing cGMP capacities to meet market demand.

 

Scalability at your fingertips


Our facilities and processes are built with scalability in mind. In process development setting, we are equipped to support processes up to 250L. For cGMP, we offer suspension-based processes from 50L to 2,000L in addition to adherent processes at various scales. We rely extensively on single-use and disposable technologies in both upstream production and downstream purification to allow cost savings while reducing potential risks of product cross contamination.

We have scaled up to 2,000 L for multiple gene therapy programs and we are ready to take on your AAV, lentivirus, adenovirus or oncolytic virus manufacturing project at any point from concept to patient. We can support programs with process and assay development, clinical manufacturing and commercial production.


Technologies


AAV manufacturing

We produce AAV using various processes ranging from HEK293-based transient transfection, Hela cell-based producer cell lines with Ad helper infection to recombinant baculovirus-based methods with insect cell lines to process.

Our proprietary clonal HEK293-based suspension processes for transient transfection are designed to be scalable and robust for your AAV production needs.

Lentivirus manufacturing

Our teams have experience in providing lenti process development and GMP production services using both transient transfection and stable packaging cell-line-based processes.

We can produce vectors with either adherent or suspension-based platforms and remain flexible to address your needs.

 

Other viruses

We also produce adenoviral vectors and oncolytic viruses. We have worked with various host cells and support both adherent and suspension-based processes.

Our group produced Adenovirus Type 5 Reference Material in 2001 for industry to be used to validate internal reference materials and assays.

Why choose us?

  • 20+ years of cell and gene therapy GMP expertise
  • >120 process development projects in cell and gene therapy
  • 2000 L AAV: First CMO to manufacture AAV at 2000L
  • Track record of >50 viral vector customers served
  • Proprietary scalable manufacturing platforms for AAV, lenti and adeno viruses
  • Flexible capacity for viral vector manufacturing at our Houston facility
  • Regulatory support throughout your clinical and commercial journey

cell and gene therapies


our global network

Our global network of four centers of excellence spans across three continents: Our sites in Portsmouth, NH (USA) and Singapore (SG) provide clinical and commercial manufacturing, while Pearland, TX (USA) and Geleen/Maastricht (NL) offer integrated cell and gene therapy services that include process/analytical development, as well as clinical and commercial manufacturing.

Portsmouth, NH, USA

Clinical Manufacturing, Commercial Manufacturing, Cell and Gene Manufacturing

101 International Drive
Portsmouth, NH 03801
United States of America

Tuas, Singapore

Production, Sales & Support

35 Tuas South Ave 6
Tuas 637377
Singapore

Houston, TX, USA

Clinical Manufacturing, Commercial Manufacturing, Cell and Gene Manufacturing, Viral Vector Manufacturing

14905 Kirby Dr
Houston, TX 77047
United States of America

Geleen, The Netherlands

Clinical Manufacturing, Commercial Manufacturing, Cell and Gene Manufacturing, Process Development, Analytical Development

Urmonderbaan 20B
Geleen
Netherlands