Autologous cell therapy is a promising and emerging therapy field, where a patient’s own cells are extracted, expanded, and then transferred back to the patient. The most mature of the autologous therapies is based on Chimeric Antigen Receptor T-cell (CAR-T) technology. In an emerging, rapidly changing therapy field like CAR-T it can be challenging to know how to best take your therapy through the development stages in a fast and cost-efficient manner. We aim to be there, together with you, to share our insights from pioneering therapies in the past. Regardless of your starting point, we can help you develop a robust, scalable manufacturing process, and support you in navigating the regulatory landscape on your path to commercialization. 

 

woman and man in lab
 

Our CDMO Services 

We have been in the cell manufacturing business for over 20 years, making us one of the most experienced players in this field. Within the autologous space, we are privileged to work with you all the way from process concept initialization through to clinical trials, and commercialization. 

  • Design of complete process flow and optimization of individual unit operations to full feasibility
  • Manufacturing of viral and non-viral CAR-T and other autologous clinical trial material, including batch viral
  • A global network of manufacturing sites for your product commercialization spanning all key territories, incl. North America, Europe, and Asia.
  • Development of automated manufacturing platforms

 

  

To offer you services that fully meet the requirements of your future therapy, we continuously invest in innovative, advanced technologies across the entire autologous manufacturing process. As this area is rapidly changing, our technologies are changing too. We strive to work closely together with you to understand your process needs and learn how we can support you even better in the future.

 

 

 
LV Unit  

Large-scale Transfection Made Easy 

The 4D Nucleofector™ LV Unit allows for closed, large-scale transfection of cell numbers in the range of 1x107 to 1x109. Transfection protocols can be established in small scale using the X Unit. The process can subsequently be transferred to the LV Unit without the need for re-optimization.

  • Ex-vivo modification of human primary cells for the development and establishment of cell therapy applications (e.g. genome editing, generation of CAR-T cells)
  • Transient production of potential therapeutic proteins or antibodies for construct screening
  • Generation of large numbers of transiently modified primary cells for cell-based assays

Note: Nucleofector™ Kits and Devices are for research use only and are not intended for human therapeutic or diagnostic use.

 

 

 
x-vivo bottle
 

Balanced Nutrients for Hematopoietic Stem Cells and T-cells

 

X-Vivo™ Medium is a hematopoietic cell medium that provides nutritionally complete and balanced environments for a variety of cells.  X-Vivo™ Medium with the addition of specific supplements has also been shown to work well with T-cells in a variety of CAR-T applications. 

 

X-VIVO™ Medium is available in three formulations:      

  • X-VIVO™ 15 Medium: Richest medium to support most cell types: human and mouse CD34+ cells, CD4+ T cells, leucocytes, neutrophils, dendritic cells, human bone marrow MNC’s.
  • X-VIVO™ 10 Medium: Human ES cells, Lymphocytes
  • X-VIVO™ 20 Medium: Peripheral Blood Mononuclear Cells (PBMC’s) 

X-VIVO™  10 and 15 Media available in non-animal origin formats

 

 

 

 
cocoon
 

Automating the Future of Personalized Medicine

 

The Cocoon™ technology, currently under development in collaboration with Octane Biotech, is based on an automated GMP-in-a-box concept for autologous cell therapy manufacturing. The goal is to provide a scalable and cost-efficient solution to current autologous cell therapy manufacturing bottlenecks. 

Cocoon™ is being designed to include the following features:

  • Integration of all key unit operations, including activation transduction, expansion and harvest, as needed, into a closed, disposable cassette
  • Monitoring and control of temperature and gases, pH and DO
  • Hands-off cultivations through an integrated 4°C cold chamber that allows for preloading of process reagents
  • Information logging and control with electronic batch records for full product traceability

 

 

We are now inviting Alpha and Beta testers to work together with us to develop an automated manufacturing solution for autologous therapy. If you are interested in becoming a Beta tester, please contact us directly: custom@lonza.com