Q: How would I choose one mode over another?
The mode of choice is based upon a combination of requirements, which are typically process specific. Process optimization is often the only way to truly evaluate which mode is best for your requirements. Batch is the most common mode and relies upon an endpoint. Fed-batch is a mode is often used to improve cell viability towards the later stages of growth to increase the overall productivity. Perfusion is often used to increase the longevity and density of the culture, which in turn increases the overall productivity of the run.
Q: I understand that there are many different kinds of bioreactors for mammalian cell culture, what kind do you use and why?
We use stirred tank bioreactors (STR) designed and manufactured specifically for mammalian cell culture. These units are flexible in design in that they can be run in batch, fed-batch or perfusion modes.
Q: Is your facility licensed and inspected by the FDA?
The facility has been licensed by the State of California for the manufacture of biological materials. We have an establishment license from the FDA.
Q: Our Company is very strong in the development end, but has limited expertise in regulatory submissions. Does your company provide regulatory assistance services?
Yes
Q: What size bioreactors does Avid Bioservices currently operate?
We currently have 4 units with 22.5L, 100L, 300L and 1,000L working volumes.
Q: Your competition talks about their proven track record of producing biologicals, have you or are you currently producing any Phase III or licensed biologicals?
While it is true that we have recently entered the contract manufacturing market, we are not new to producing pre-clinical to Phase II biological materials. We are currently manufacturing several Phase III products.
