Lyfgenia (lovotibeglogene autotemcel) was produced at the cell and gene therapy (CGT) focused firm’s 71,200 square-foot Allendale facility in New Jersey, US.
According to the firm, the facility passed the US Food and Drug Administration’s (FDA) pre-licensing inspections, making it necessary capabilities and expertise to successfully manufacture CGT for commercial use.
“The commencement of commercial manufacturing for Lyfgenia represents an important step for the CGT industry as it will allow many patients fighting sickle cell disease to benefit from this new, potentially curative medicine. Now, I am pleased to announce that Minaris Regenerative Medicine has commercial manufacturing experience in all three of our regions, Japan, Germany, and now the United States,” said Hiroto Bando, CEO, Minaris Regenerative Medicine.
Approved by the FDA in December 2023, bluebird’s Lyfgenia, also known as lovo-cell, is a one-time gene therapy with the potential to resolve vaso-occlusive events (VOEs) and is custom designed to treat the underlying cause of the disease.
In 2023, bluebird took a two-pronged approach to raise funds to support its gene therapy. It commenced an underwritten public offering of $150 million with plans to provide the underwriters with an extra $22 million worth of its stocks.
During its Q4 earnings call in April, bluebird reassured the investors of capacity in place for the production of Lyfgenia and said it expects first revenues to materialize in Q3 of 2024.
Lyfgenia functions by integrating a functioning β-globin gene into the patients’ own hematopoietic stem cells (HSCs). After successful engraftment, sustained generation of adult hemoglobin with anti-sickling characteristics (HbAT87Q) is anticipated. This can potentially lessen VOEs, restrict red blood cell sickling, and has an oxygen-binding affinity comparable to that of wild-type HbA.
The sickle cell therapy, Lyfgenia will be available at the firm’s established network of qualified treatment centers (QTCs).
In 2021, CDMO Minaris collaborated to manufacture bluebird’s gene therapy Skysona (elivaldogene autotemcel, which is treatment of early cerebral adrenoleukodystrophy (CALD).
Minaris did not respond when contacted by this publication.
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