PsyBio Therapeutics Corp. reported that it has demonstrated the ability to manufacture PsyBio-11040, one of its first promising therapeutic candidates, at a commercial scale.
The company said this is the result of numerous dedicated employees, consultants and contractors committing thousands of hours and almost a year of efforts that have taken the technology, exclusively licensed to PsyBio, from bench scale to commercial scale.
"This achievement demonstrates the formal utility of the technology to produce psycho-targeted therapeutic candidates," CEO Evan Levine said in a statement.
"This is the culmination of efforts across the company and provides a basis for our confidence moving forward with candidate development as one of the only biotechnology companies in the psychoactive therapeutic industry with the ability to manufacture therapeutics at scale."
READ: PsyBio Therapeutics submits its first pre-IND application meeting request to FDA
Scale up to full production was achieved utilizing a commercially available, stainless-steel bioreactor with integrated continuous readout probes as well as ongoing sample analysis to gather real-time data on the process.
Similar pilot-scale processes were tested, and modifications were made as necessary to provide the information on which the larger-scale processes were based.
The company said it is expected that similar scale-up procedures and outcomes will be replicated across its therapeutic candidate strains as additional promising target candidates undergo tech transfer to commercial manufacturing. It expects to commence manufacturing on a commercial scale in the first quarter of 2022.
"This demonstration is very helpful as it provides the ability to manufacture a sufficient quantity of product to allow further development including producing clinical batches for preliminary stability testing and pre-clinical/clinical testing from a single production batch,” chief medical officer Dr. Michael Spigarelli added.
"This will allow us to move forward with the Chemistry Manufacturing and Controls (CMC) development processes as part of PsyBio's Quality by Design (QbD) strategy to produce psycho-targeted therapeutics intended to improve mental and neurological health."
PsyBio is an intellectual property-driven biotechnology company developing novel, bespoke, psycho-targeted therapeutics to potentially improve mental and neurological health.
Contact the author at stephen.gunnion@proactiveinvestors.com