Here is the second/last post of my notes from the ASM. This is about the PDL tour after the Q&A.
After Q&A we went to the PDL tour. It was just before the tour that Richard congratulated me for asking the questions about the reactors. He said that was the first time in 25 years that he had heard a question about the reactors at an ASM. (A couple of the board members also thanked me for the reactor question) Then Richard he told me the new Thermo Fisher reactors were actually square. He recently saw them at a conference.
On to the tour…..
The micro-reactors (30 new bench scale controllers standardizing with a 3L micro-reactor) in 8000 sqf in the Franklin building allow the development timelines to be compressed. The new PDL also has a 50L and 200L pilot plant (mid-range/intermediate scale). The bench-scale allows results of many runs (usually 3L) to be over-laid to show consistency and to set parameters and ranges for the process.
I had a question about how they would scale up from this leading-edge, industry-standard, 3L (or 15L) micro-reactors and controllers to the newly designed square reactors from Thermo Fisher. They said the objective in the lab is to remove these engineering differences. Engineering differences exist between different manufacturers (Thermo Fisher v Mobius), different sizes (200L v 2000L), as well as different designs (cylinder v square or stainless steel v single use). So they use dimensionless parameters. Thermo Fisher will be asked to show them that these parameters are achievable with their reactors. The vendor will be asked to provide scaled-down (pilot/intermediate) models of the squared reactors.
Samples from the bench reactors and from the pilot sized reactors are taken constantly to be analyzed to track variances and consistency. That allows the parameter ranges to be identified statistically. The product from the pilot-scale reactor belongs to the client to use as they need. The client can run preclinical trials with this pilot size batch.
After harvesting the material from the pilot batch they take it to the downstream lab where the material is purified by running it through columns of resin. That purification process can then easily be scaled up to manufacturing sized columns.
We know the facts so your FUD (Fear Uncertainty and Doubt) is useless here.
