Yesterday some members of the Chemistry Club visited the Genentech headquarters in South San Francisco and toured the cell culture pilot plant.
A pilot plant mass produces recombinant E. coli and Chinese Hamster Ovary (CHO) cells for use in further research and testing. The process starts with an original sample of E. coli or CHO, usually obtained from a research lab. It is grown in a 10 liter bioreactor where the pH, O2 concentration, temperature, and nutrient levels are closely monitored. After the cells are grown, samples are placed in a larger bioreactor and a even bigger one once the previous stage is completed. CHO doubles every 72 hours and E. coli doubles every 20 minutes, so these samples must be transferred as they grow. After the cells are cultured, the samples are homogenized and run in an array with pores that separate proteins from lipids and DNA. The proteins are isolated using column chromatography loaded with Protein A (a resin with affinity for a wide range of proteins).
Many of the processes that go on in the pilot plant are completely automated in order to decrease production time and eliminate human error. All of the bioreactors are automated, probes with in the bioreactors will measure and regulate the conditions inside. Other devices can count the number of cells as well as determine the viability of the cells. There is a even a device that labels tubes and gives each of them unique barcodes. If you have messy handwriting, you never have to worry!
The pilot plant focuses on small scale manufacturing to observe and optimize the process that will be used in larger scale manufacturing. This is an intermediate step between research and mass manufacturing. Much of the process is a large-scale application of lab research being done at UCSC. Once the protein or small molecule can be produced on a large scale, it will enter testing to see if it is a viable drug.
It costs $3 billion and takes 15 years to produce a drug that will be on the market. Genentech prides themselves on incorporating sustainable processes. All waste after production is neutralized and disposed, any hazardous waste is collected by Genentech and disposed of properly, and materials used are recyclable. The whole campus is aiming towards sustainability by providing charging stations for electric/ hybrid vehicles, waste sorting such as compost and recyclables, and environmentally friendly chemical disposal.