Under the agreement, the process development and good manufacturing practice (GMP) compliant production of BaroFeron (interferon beta-1b) will involve Avecia integrating BaroFold's PreEMT protein processing technology in both pilot and GMP facilities.
BaroFold's protein processing technology uses hydrostatic pressure to disaggregate and refold recombinant proteins from aggregates and inclusion bodies.
According to the company, the PreEMT process refolds proteins at high concentrations (greater than 20g/L), which results in higher yields of native protein (around 100 per cent) and safer product formulations.
Using the technology, suspensions of aggregated protein are placed in a vessel to which high pressure is applied.
BaroFold claims that dissolution of aggregates can occur in as little as five minutes, with biologically active, native protein recovered within a matter of hours.
The process has been successfully applied to over 200 proteins, and according to BaroFold can lead to cost of goods savings of over $100,000 (€70,791) per kilo of protein.
The company generates revenues by licensing out the PreEMT technology to selected firms on a protein specific basis, listing pharma heavyweights Pfizer and Genentech on its client list among others.
These partnerships focus on improving the safety, efficacy, ease of manufacture or delivery profiles of monoclonal antibodies or protein therapeutics, with BaroFold's capabilities potentially enabling life-cycle extensions by developing improved follow-on compounds of existing biologic drugs.
Back in May the company announced that it had raised $12m in private placement, funds that are to go towards developing the company's therapeutics pipeline (including the BaroFeron MS candidate).
The Avecia partnership will help drive development of the PreEMT technology as well as providing GMP product for clinical trials of BaroFeron. Completion of the scale-up of the drug manufacturing process is seen as a significant milestone, providing a platform to potentially expand the use of the PreEMT technology to other areas of protein manufacture, and enable the development of next generation protein biologics.