CMO Angel signs stem cell production deal
Contract manufacturing organisations (CMO) offering stem cell production services in Europe require licenses from the Medicines and Healthcare Products Regulatory Agency (MHRA).
By gaining this at its Edinburgh, Scotland facility Angel has equipped itself to profit from rising demand for stem cell manufacturing. This is part of Angel’s efforts to develop the capacity to provide services “for such advanced biological therapies”.
Gordon Sherriff, chief operating officer of Angel, explained that this is the company’s “core competence”, adding that the “contract firmly places Angel in the vanguard of this important and exciting development in medicinal therapy”.
Under the terms of the deal Angel will manufacture clinical-grade lots of ReNeuron’s second-generation CTX stem cell line for use in preclinical and clinical applications. The second-generation cell line can be frozen for shipping to multi-centre clinical trials.
ReNeuron will use the CTX cell line for proof-of-concept clinical trials with its ReN001 stem cell therapy for disabled stroke patients. Furthermore, ReNeuron is moving ReN009, a treatment for peripheral artery disease, through late preclinical and into human trials.
Manufacturing stem cells
Angel has equipped its Edinburgh facility, and received the appropriate license, to manufacture cellular therapies and this is key to the companies aim to be at the “vanguard” of the sector.
Housed in the facility are three independent manufacturing suites allowing simultaneous multi-use. These are equipped to handle category II class organisms and use a single HVAC system to provide HEPA filtered air to each room.
Equipment in the rooms includes a 30L fermenter and a 30L cell culture bioreactor system. These are used after processes have been developed in non-current good manufacturing (GMP) cell culture suites using Wave bioreactors or up to 10L fermenters.
