BlueJay Therapeutics selects Lonza to manufacture its HBV antibody candidate; BiVictriX contracts Abzena; Samsung Biologics will manufacture drug substance for GreenLightâ€™s mRNA COVID-19 vaccine candidate. Great to have you here for BioProcess Insiderâ€™s CDMO round-up.
First up in our contract development manufacturing organization (CDMO) round-up is Swiss company Lonza, which BlueJay Therapeutics recently selected to provide a tailored program to support production of BJT-778 a monoclonal antibody (mAb) drug candidate targeting chronic hepatitis B virus (HBV) infection.
Under terms of the agreement, Lonza has tailored its Ibex Dedicate offering to manufacture material for preclinical and clinical testing. The CDMO will cover the early stages from gene to IND and provide cell line, process, and analytical development as well as drug product manufacturing at its Visp, Basel, and Stein sites â€“ all in Switzerland.
Lonza will use its GS Xceed Expression System to express BJT-778.
â€śThis collaboration signifies our commitment and flexibility in accommodating the specific and unique needs of emerging biotechs taking their lead candidate to clinic,â€ť Jeetendra Vaghjiani, executive director, clinical development & strategic marketing, Lonza, said.
“Our team has extensive expertise to set up a customized formulation platform, proactively anticipate risks and suggest mitigation measures that will help move BlueJay’s candidate from preclinical stages into the clinic.”
Up second, we have UK-based Â CDMO Abzena, which has been selected by next generation cancer therapy development firm BiVictriX Therapeutics to manufacture its anti-cancer antibody-drug conjugates (ADCs).
According to Abzena, the collaboration will enable BiVictriX to cost-effectively produce its anti-cancer ADCs for pre-clinical models and removes the need for extensive manufacturing capabilities of its own.
ADC production will be carried out in two phases. Firstly, ADCs will be manufactured for proof-of concept studies, and after this it will cover ADC lead selection and optimization.
Thirdly, we have South Korean CDMO Samsung Biologics, which has signed a supply agreement with Boston-based biotech GreenLight Biosciences to produce commercial drug substance for its messenger RNA (mRNA) COVID-19 vaccine candidate.
The partnership aims to drive production of GreenLightâ€™s COVID-19 vaccine candidate for Phase III clinical trials as well as commercial scales (subject to regulatory approval).
A technology transfer from GreenLight to Samsung will begin immediately and the CDMO will use the existing manufacturing process.
â€śWe are delighted to partner with GreenLight to leverage our expertise in manufacturing a messenger RNA COVID-19 vaccine candidate to better serve patients in lower income countries,â€ť John Rim, CEO of Samsung Biologics, said in a press release.