Q & A with Dr. John Zhang, COO of CL Biologics
Question: What is CLB’s organizational goal?
At CL Biologics (CLB), our goal is to provide affordable medicines to the world, that meet or exceed the regulatory expectation of every regulatory agency including the NMPA, the EMA, and the FDA. Our Quality systems are world class and designed to meet the strictest requirements from each of the major regulatory bodies. Likewise, our facilities are designed to meet, or in some cases exceed those requirements, all while reducing the manufacturing cost of drugs for patients. Our innovative facility design allows us to reduce operating costs, which reduces the total cost to our clients and the patients they serve.
Question: Scale flexibility is an industry need. Overall, can you describe how CLB meets this need?
Our manufacturing facility is designed to meet the needs of any client, from pre-clinical IND enabling runs all the way through 15,000L commercial runs. Our clinical manufacturing facility includes 200L and 500L single-use bioreactors from Cytiva, Sartorius, and Thermo Fisher. Single-use bioreactors reduce the cost of manufacturing for the smaller volumes required at the clinical stage, while offering significant flexibility. Combining our clinical manufacturing facility with our on-site DP capabilities (liquid, lyophilized, or pre-filler syringe) reduces our timelines from tech transfer to drug product by several months, enabling quicker product release to clients. As products move to Phase 3 clinical and beyond, scale becomes an important factor in reducing the unit cost for the drug product. The CLB manufacturing facilities are designed to accommodate the most cost-effect scale for every client. The commercial demand, titer, and yield per batch each factor 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.
Question: Your stainless steel offers many advantages. Can you give some examples?
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’ve 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.
Question: Facility down time can affect supply timelines. How does CLB reduce supply lag?
Preventative maintenance and routine calibrations on utility systems are a vital component to maintaining and operating a production facility. At CLB we’ve implemented improved systems designs to minimize the frequency of plant shutdowns. Critical components of the utility systems have been upgraded to a higher grade stainless to prevent rouging, a common occurrence on stainless steel components. We’ve also upgraded the elastomer components to Tuff-steel or Teflon to extend the life of the elastomers. To reduce downtime due to calibrations, we’ve implemented slipstreams with redundant instruments. The instruments can be taken off-line for calibration while the system is still running, then steamed back in-line after the calibration is complete. These facility designs allow the manufacturing facility to extend the time between shutdowns, which further increases our capacity and lowers our operating expenses.
Closing Remarks
Innovative facility design increases our capacity and lowers our operating expenses. Combined with our world class Quality systems, CL Biologics is able to supply safe, effective, and affordable therapeutics to China and the rest of the world.
