Tzield received the green light from the FDA in November in what the American Diabetes Association heralded as a ‘tremendous accomplishment’. It is the first and only approved treatment to delay the onset of Stage 3 type 1 diabetes in adult and pediatric patients aged eight years and older with Stage 2 T1D.
Clinical trials in Stage 2 T1D patients showed that Tzield delayed the median onset of Stage 3 T1D by around two years – thus delaying the burdens, complications and risks associated with Stage 3 T1D such as life-long insulin injections.
AGC Biologics runs multiple mammalian cGMP manufacturing lines and a variety of scales at its Seattle facility. The campus serves as a center of excellence for formulation and employs the latest fed-batch and perfusion manufacturing processes and houses a new microbial-based manufacturing line system. The AGC Biologics Seattle campus has produced biologics products for 30 years.
“Provention Bio chose AGC Biologics to manufacture TZIELD after the CDMO helped guide the product through Process Performance Qualification (PPQ) manufacturing and validation batches, and FDA approval,” notes AGC Biologics.
Achieved in 2020, the PPQ manufacturing campaign consisted of three commercial scale runs required for the validation of the drug substance manufacturing process and the demonstration of the ability to manufacture consistently, batch-to-batch, at commercial scale.
More than 1.8 million Americans have T1D, an autoimmune disease caused by the destruction of beta cells.
“The multi-year process of shepherding a new therapy from clinical research to commercial launch requires the collaboration of multiple partners, and we are grateful for the ongoing strategic collaboration of AGC Biologics as we begin to deliver Tzield to patients,” said Provention Bio CEO Ashleigh Palmer. “This is an-important milestone for the Type 1 Diabetes community, and we hope the launch of this therapy can truly make an impact on patients and families seeking innovative treatments for the delay of Stage 3 T1D.”