Successfully Demonstrates Commercial Scale Manufacturing PsyBio is one of the only biotechnology companies in the psychedelic industry with the ability to manufacture therapeutics at commercial scale
OXFORD, Ohio and COCONUT CREEK, Fla., Oct. 7, 2021 /CNW/ - PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) ("PsyBio" or the "Company"), an intellectual property driven biotechnology company developing new, bespoke, approvable psycho-targeted therapeutics to potentially improve mental and neurological health, today reported that it has demonstrated the ability to manufacture PsyBio-11040, one of its first promising therapeutic candidates, at commercial scale. This achievement is the result of numerous dedicated employees, consultants and contractors of PsyBio 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," stated Evan Levine, PsyBio's Chief Executive Officer. "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."
Scale up to full production was achieved utilizing a commercially available, stainless-steel bioreactor with integrated continuous read out 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. It is expected that similar scale up procedures and outcomes will be replicated across PsyBio's therapeutic candidate strains as additional promising target candidates undergo tech transfer to commercial manufacturing. The Company 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," stated Michael Spigarelli, MD, PhD, MBA, PsyBio's Chief Medical Officer. "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."
https://www.newswire.ca/news-releases/psybio-therapeutics-successfully-demonstrates-commercial-scale-manufacturing-feasibility-810419466.html