Manufacturing (M)
Commercial Manufacturing
As products move to Phase 3 clinical and beyond, scale becomes an important factor in reducing the unit cost for the drug product. CLB manufacturing facilities are designed to accommodate the most cost-effective scale for every client. The commercial demand, titer, and yield per batch each factors into determining the correct scale to minimize costs.
Our 5,000L stainless steel facility offers the flexibility of harvesting from either the 5,000L bioreactor or the 1,000L bioreactor. The 1,000L bioreactor also has perfusion capabilities. This enables CLB to manufacture perfusion, fed-batch, or concentrated fed-batch, all from the same facility. Likewise, we can harvest from either the 15,000L bioreactor or the 3,000L bioreactor within our large-scale stainless steel facility with the same perfusion capabilities in the 3,000L bioreactor.
Our Shenzhen and Shanghai sites will start commercial manufacturing by Q4 2023, and reach full capacity of ~700 kL by end of 2024. Such scale will offer significant advantages for our clients in both time to market and production costs.
For any questions regarding commercial manufacturing, please drop us a line and we will get back to you soon.
CLB large vessel production lines
Our stainless steel manufacturing facilities are each designed with 12 production bioreactors feeding into 2 purification suites. This significantly increases our capacity and lowers our operating costs compared to a traditional bioreactor suite with 4 or 6 production bioreactors. Along with the increased capacity, we also increased the support equipment such as CIP skids and hold vessels. This allows us to run at a very high production rate which further reduces our operating expenses. These factors combine to allow CL Biologics to efficiently utilize our manufacturing facilities to provide a lower cost to our clients.
Medium Scale (12 x 5,000L)
- Bioengineering bioreactor design (Swiss)
- ASME certified stainless steel
- N-1 direct harvest, N-1 perfusion
- Reduced cost for commercial manufacturing
- Reduced cost of raw materials
Large Scale (12 x 15,000L)
- Zeta bioreactor design (Austria)
- ASME certified stainless steel
- N-1 direct harvest, N-1 perfusion
- Lowest possible cost per vial for commercial manufacturing
- High run rate, low down time
