European regulators have suspended the distribution of autologous and allogeneic cell-based vaccine candidate Gliovac following an inspection at ERC’s site in The Netherlands.
The inspection took place on February 25 at the Schaijk facility, located about 75 miles southeast from Amsterdam, and resulted in a statement of non-compliance with good manufacturing practice (GMP) being issued.
“ERC The Netherlands B.V. showed a lack of ability to adhere to the principles of Good Manufacturing Practice for ATMPs [advanced therapy medicinal products],” the statement says.
Image: iStock/DariaRen
In total, thirteen deficiencies were observed, including one ‘critical’ and one ‘major.’
“As a result of this, the quality and safety of the product ERC1671 Gliovac manufactured at the site is not ensured,” the statement adds, with the national competent authority (NCA) ordering the suspension of the distribution of the advanced therapy candidate until a sufficient GMP level has been confirmed.
ERC1617 – or Gliovac – is an advanced immunotherapy based on freshly extracted tumor cells and lysates that stimulates the patient’s immune system to recognize and reject cancer cells. It combines
autologous cells and allogeneic – off-the-shelf – cells, generated from the glioma tumor tissues of three different donor cancer patients, and the lysates of all of these cells. When injected, the mixture stimulates the patient’s immune system to mount an immune response against the tumor cells, which may lead to their destruction.
The product is in Phase III trials for recurrent glioblastoma for which there are no effective available treatments, though the company has continued to make ERC-1671 available for compassionate use.
The regulatory non-compliance report will not affect ERC’s commercialization strategy, according to CEO Apostolos Stathopoulos.
“ERC has GMP production capabilities in Europe and the US which are compliant with US and European requirements. As ERC ramps up for market production, in anticipation of conditional marketing approval in the EU, a recent audit by European authorities have recommended some upgrades in process and controls to our European production plant as we transition from clinical trial production to market production,” he told BioProcess Insider.
“All of ERC’s production plants remain in GMP compliance and were never out of compliance. The upgrades to the European plant have been completed and we are well underway to resume production. The result has been a slight interruption in production which is being rectified.”
ERC GMP non-compliance doc by Dan Stanton