State-of-the-Art cGMP Manufacturing
We have our own end-to-end fully integrated cGMP manufacturing facility, ready to support advancement of our clinical programs.
We believe that manufacturing is a critical component to the success of cell therapies. At an early stage, we have made strategic investments in our people, process and production facility. Our team is led by experts in the field with proven experience in manufacturing cell therapy products and taking them through regulatory approval.
The design of our manufacturing process creates efficiencies by enabling – within one manufacturing suite – the production for multiple product candidates. Our Tmod™ platform is compatible with both autologous and allogeneic manufacturing. We are incorporating and designing quality into our process and operations, and investing early in automated, closed system manufacturing and quality assays including potency.
Our facility is built to optimize for cost, speed and quality of production. Use of automation throughout the manufacturing process reduces the need for manual labor and the risk of human error or contamination. Our employment of digital infrastructure streamlines data management, batch records and barcoded chain of custody and chain of identity tracking, aspects critical to the delivery of personalized medicine.
A2 Bio Manufacturing Highlights:
- End-to-end fully integrated facility
- Autologous and allogeneic capability
- Automation and digital infrastructure
- Proven cell therapy manufacturing expertise