|JHL Biotech CEO Racho Jordanov|
JHL Biotech said it has successfully completed the GMP manufacture and lot release of its first 500-liter scale batch from its Taiwan facility for a privately held Chinese biotech company of its unspecified oncology monoclonal antibody product for use in Phase I clinical trials in Australia.
In a May 18 release, the company said it also handled assay development, reference standard filling/qualification and implementing tight process controls to produce material matching the initial quality parameters as well as viral clearance and validation.
"The release of GMP clinical material is an important milestone for our contract manufacturing operation," said Racho Jordanov, president and CEO of JHL Biotech.
Last week, the company announced it had closed on a Series C fundraising of $45.6 million under existing investor Milestone Capital and with new investors Sungent BioVenture and Liwick Investment Management.
The company, with offices in China and Taiwan, said in a press release that since it started in 2012, JHL Biotech has raised over $135 million in new equity issuances. The company has previously said it plans to list on Taiwan's Emerging Stock Board.
- here's the release from JHL Biotech (PDF)