samedan logo

home > news > detailed info

NovalGen Enters Strategic Partnership with HALIX B.V. to Manufacture Clinical Trial Materials



LONDON, United Kingdom and LEIDEN, The Netherlands, February 22, 2021 / B3C newswire / --NovalGen Ltd. (“NovalGen”), a biopharmaceutical company developing breakthrough cancer therapies and HALIX B.V. (“HALIX”), a contract development and manufacturing organisation, today announced a strategic partnership. Within the scope of this partnership, HALIX will provide manufacturing of clinical supply of NovalGen’s therapies.


NovalGen’s innovative platform technology has been successfully deployed at HALIX to manufacture clinical trial material for NovalGen’s first clinical program. The program, NVG-111, is a Receptor Tyrosine Kinase Like Orphan Like Receptor 1 (ROR1) targeting bispecific antibody T cell engager for the treatment of hematologic malignancies and solid tumors, is expected to enter the clinic in the first half of 2021. HALIX has supported NovalGen with the successful completion of GMP manufacture of NVG-111 from drug substance up to drug product and final release. The strategic partnership and collective expertise of both organisations has ensured an efficient technology transfer and further development of the process leading to a successful GMP manufacturing campaign.

“This collaboration with HALIX will ensure high quality, rapid and secure manufacture of clinical supplies for our current and future products. Using cutting-edge manufacturing technologies at our partner’s state-of-the-art cGMP facility, we are progressing to become a clinical stage company,” said Kieran ODonovan, SVP Chemistry and Manufacturing Controls  at NovalGen.“We developed a manufacturing process around the use of transient transfection to accelerate timelines and reduce costs, whilst delivering product of the highest quality. In HALIX we found the ideal partner; experience in transient transfection, modern facilities, strong leadership and a laser focus on delivery to bring NVG-111 from contract signature to vials of clinical drug in less than seven months.”

“The partnership with NovalGen has  been a great success,” said Alex Huybens, Chief Operations Officer at HALIX. “Working closely together and utilizing the collective bispecific antibody expertise of both teams has enabled us to meet the ambitious timelines and efficiently transfer the process and deliver the product to be ready to enter the clinic. We look forward to a long and productive collaboration with NovalGen.”

phone +44(0207) 431 7976
email NovalGen Ltd Argyle House Joel Street Northwood Hills HA6 1NW, UK
Print this page
Send to a friend
News and Press Releases

AirBridgeCargo Airlines Transports Vaccine Manufacturing Equipment To Ramp Up Production Capacity Of Up To 600,000 Vials Per Day

AirBridgeCargo Airlines (ABC), one of the leading air cargo carriers for transportation of special cargo, has been aiming at 360-degree support of COVID-19 vaccine manufacturing, including through stable shipments of vial-producing equipment.
More info >>

White Papers

eSource: Reducing Site Workload for Better, Faster, Safer Clinical Trials

Clinical Ink

Unlike traditional electronic data capture (EDC), SureSource, Clinical Ink’s eSource platform, was designed from the beginning to minimize clinical trial complexity for site users. A Site Impact Survey provides scientific evidence regarding the impact of SureSource from 517 site users. Results confirm it significantly reduces workload, lessens queries, and improves data quality compared to paper and EDC. In this white paper, we quantitatively evaluate survey outcomes, provide qualitative feedback from survey respondents, and highlight the observed benefits of SureSource for transforming clinical research.
More info >>

Industry Events

DIA Europe 2021

15-19 March 2021, VIRTUAL CONFERENCE

DIA Europe is the must-attend event for all life science professionals working in drug development, from discovery to marketed use. It encourages open collaboration by bringing together representatives from the entire spectrum of the life science landscape and facilitating crucial discussions across several topic tracks: Clinical Development, Regulatory Strategy, Pharmacovigilance, Value and Access, Health Policy, and many more.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement