Cell & Gene Therapy Experience

Your Partner in Cell & Gene Therapy

We help our clients solve their most important challenges – from designing a facility to manufacture transformative therapies to accelerating the delivery of life-saving products. We give the best minds of today the platform to create the cures of tomorrow. Our experience in Gene and Cell Therapy began with the laboratory and pilot scale research of leading organizations. Our evolution follows the industry as more companies continue their research and expand into pilot and commercial scale manufacturing. We are now at the forefront of the industry as we provide solutions for preclinical and manufacturing operations for full-scale launch and production facilities.

Solutions:

  • Regulatory knowledge and expertise
  • EPCM capabilities
  • Extensive resume of executed gene and cell therapy projects, including gene therapy products and autologous and allogeneic cell therapies, at varying scales.
  • Expertise in design of pharma facilities in US, EU and Asia
  • Strong client relationships
  • Successful in attracting top talent, both experienced and out of universities
  • Domestic office locations within zones of heavy cell and gene therapy investment by clients
  • Global organizational reach
  • Large organization with significant resources

Gene Therapy

We recognize key similarities and differences between gene therapy facilities and traditional mAb facilities and provide innovative solutions that help clients with critical product speed to market. We recently completed a Commercial Scale Gene Therapy facility for Pfizer in the Southeast United States that involved Adeno-associated virus (AAV) Vectors. We worked on Clinical Scale Gene Therapy for Spark Therapeutics which also has AAV vectors and BSL-2 in support of the production. For BioMarin, we provided engineering for their Gene Therapy Facility project that provided additional production capacity with multi-product flexibility to support the manufacture of genetically modified insect cells and baculovirus.

Cell Therapy

We understand the various operational and regulatory challenges that cell therapy companies face. We provide clients with expertise in the design and construction of facilities for autologous and allogeneic cell therapies at varying scales. We are currently designing cell therapy suites operating single-use autologous cell culture bioreactors. We designed Bristol Myers Squibb / Celgene’s manufacturing of patient products that involve culture initiation and transduction, expansion and harvest, apheresis receiving, cryopreservation, QC laboratory space, and kitting.

Regulatory Compliance

As a novel technology, cGMP and regulatory principles remain to be fully established and tested for these commercial scale manufacturing facilities. We actively work with clients as they develop facilities that address FDA and EU expectations. We address the need for a unidirectional flow in the personnel and material flows, appropriate room classifications for downstream manufacture and purification, and multi-product and viral reduction step segregation.

Single Use Technology and Equipment Analysis

As an industry leader in single use technology, our recent advances in process platforms provide a flexible, sustainable, and reproducible manufacturing facility with significant reductions in capital and operating cost. Our focus is on optimizing industry leading technology to maximize multi-product flexibility through plug-n-play manufacturing, reconfigurable clean rooms, optimizing disposable technology, media/buffer/ product bag transport systems, and tube management.

One of the significant challenges in Cell and Gene Therapy commercial manufacturing is determining the appropriate amount of equipment to accommodate a specific patient per year throughput. We use tools, such as FlexSim, to analyze the variability in events and step duration. This provides better data to determine equipment needs and right size the facility.

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