BioLyo was spun out of ILiAD Biotechnologies in January 2020. Prior to 2020, all process development and GMP manufacturing activities for ILiAD’s live attenuated pertussis vaccine BPZE1 were outsourced to CDMOs. Once BPZE1 had progressed beyond phase IIb clinical trials, the process for the manufacture of BPZE1 needed to be characterized at small scale prior to phase III large scale process validation. However, CDMOs generally do not have the expertise to carry out process characterization for live biological products (LBPs), i.e. a drug where the active ingredient is a living bacterium. Additionally, the level of control of doing process characterization in house is far greater than when outsourcing this activity.
The spin out of BioLyo was lead by ILiAD’s Executive Director Drug Product Development Marcel Thalen, PhD. Marcel previously worked for GT Biologics (now 4D Pharma), the CDMO SynCo Bio Partners (now Wacker Biotech) and the Netherlands Vaccine Institute, leveraging 3 decades in biotech, 2 of which spent on developing (live) vaccines, microbiome consortia and other live biotherapeutics. Having worked for and worked with a number of CDMOs, Marcel experienced first hand that LBP process development and GMP manufacture is still an expertise that is largely lacking at CDMOs, which was the reason to incorporate BioLyo as a CDMO rather than as an entity that only works for Iliad Biotechnologies.