Translate Bio chooses AMRI to build out cGMP suite

Published: 20-Sep-2019

US-based Albany Molecular Research will outfit new, dedicated cGMP clinical manufacturing suites as part of a multi-year strategic manufacturing agreement with the mRNA specialists

Translate Bio has entered into a multi-year strategic manufacturing agreement with Albany Molecular Research, AMRI, a global clinical development manufacturing organisation, in support of the planned expansion of Translate Bio's current Good Manufacturing Practices (cGMP) clinical mRNA manufacturing capabilities.

Under the five-year agreement, AMRI will build out new, dedicated cGMP clinical manufacturing suites that will support the US-based clinical-stage mRNA therapeutics company's manufacturing needs. This allows for greater control and flexible access to AMRI's purpose-built cGMP manufacturing capacity, experience and expertise to advance Translate Bio's preclinical and clinical-stage programmes.

Translate Bio's lead programme is an inhaled mRNA therapeutic in an ongoing Phase 1/2 clinical trial in patients with cystic fibrosis. Its preclinical programmes are focused primarily on targets in additional pulmonary diseases and also include infectious disease targets for vaccine applications. Other discovery efforts include next-generation delivery programmes for applications in diseases that affect the liver.

RaNA Therapeutics rebranded as Translate Bio in 2017.

"At Translate Bio, we recognise the importance of developing scalable manufacturing processes in this innovative field and have made this a priority from the inception of our mRNA therapeutic (MRT) platform," said Ronald Renaud, chief executive officer, Translate Bio. "We are excited to build upon our successful experience with AMRI, a demonstrated leader in drug manufacturing, with this agreement that supports the advancement of our manufacturing efforts as we work to develop first-in-class mRNA medicines for genetic diseases."

"We are delighted to support Translate Bio in its goal of accelerating the development of its mRNA product pipeline across various stages of development," said Michael Mulhern, chief executive officer, AMRI. "Translate Bio's technology platform has the potential to transform patients' lives and we are excited to partner with them as they advance medicines to treat unmet medical needs."

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