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Consulting & Advisory

The expertise and experience to deliver your cell and gene therapy product goals.

Cell Therapies clean room 6

Navigate the challenges of manufacturing with your cell and gene therapy specialist

Our consulting and advisory capability is a vital service that can assist clients to advance their cell and gene therapy program from the translation through to commercial supply.

cell therapies has expertise in navigating the challenges of manufacturing processes, regulatory requirements, quality standards, clinical needs, and logistics for the delivery of cell and gene therapies to patients across the globe.

The expertise to advance your cell and gene therapy programs

We can advise on the whole product development pipeline from a first-in-human program, to early and late stage clinical trials through to large-scale commercial supply.

Rapid feasibility studies

Our specialists can evaluate your target product and design GMP manufacturing processes. We have extensive cell processing expertise across a number of cell types, treatment models, and culture platforms including genetic modification.

Manufacturability assessments under GMP

We have substantial GMP manufacturing process development and optimization expertise for clinical trial and commercial supply. This is supported by our GMP licenses from the TGA, compatible with global regulatory standards.

Deployment model design

With our expertise in global regulatory standards and cell therapy delivery, our cell and gene therapy specialists can help design multi-center and multi-country deployment models for your clinical and commercial products.

We can offer and have experience in:

  • Conducting detailed technical feasibility assessments of pre-clinical programs to guide development activities and prepare for clinical trials.
  • Conducting in-depth cost analysis to determine targeted product costs.
  • Conducting apheresis collection network assessments for clients to enable control of their critical starting material.
  • Conducting gap assessments to provide recommendations for a facility to meet regulatory requirements for clinical trial supply.
  • Implementing GMP training programs and CAR-T quality management systems.

Contact the Cell Therapies Team today

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Explore our services

Cell Therapies has extensive experience in the development and commercialization of cell and gene therapies for the Australian and global markets.

Contract Manufacturing

We provide rapid technology transfer, process development, manufacturing optimization, clinical trial and commercial product supply to global markets

Clinical Trial Support

We manufacture products for clinical trial, provide process development for programs, manage product storage, and supply logistics and distribution

Apheresis Management

We can help you with apheresis collection protocol development, site selection and assessment, network management, cryostorage, and distribution