Lee, MA, Sept. 27, 2023 (GLOBE NEWSWIRE) -- A historic transplant of a genetically modified pig heart has been successfully performed on a 20-year Navy veteran and married father of two suffering from end-stage cardiovascular disease. The surgery, which took place on September 20, was the patient's last chance at extending his life. He was not eligible to receive a human heart, and his disease was terminal.
The FDA granted emergency approval for the surgery on Friday, September 15 through its single patient investigational new drug (IND) "compassionate use" pathway. To prevent rejection or damage to the foreign organ, the patient is being treated with an immunosuppressive regimen including a novel antibody therapy, produced at Berkshire Sterile Manufacturing, along with conventional anti-rejection drugs.
The drug product, developed by Eledon Pharmaceuticals and produced at Berkshire Sterile Manufacturing, is a crucial component in the success of this groundbreaking transplant. The investigational antibody therapy, called tegoprubart, is designed to prevent the patient's immune system from attacking the foreign organ, allowing it to function properly and potentially extend the patient's life.
"We are proud to have played a role in this historic transplant," said Dr. Xufeng Sun, Vice President of Technical Operations at Berkshire Sterile Manufacturing. "Our team was committed to developing a successful manufacturing process to produce the antibody therapy needed to improve outcomes for this patient. We are honored to have been able to contribute to the patient's well-being and to the advancement of medical science."
The success of this transplant offers hope to the hundreds of thousands of patients in the United States that are currently waiting for an organ transplant. The surgery was the second case where a genetically modified pig heart has been transplanted into living person. Transplanting animal organs may offer a solution to the organ shortage crisis.
Berkshire Sterile Manufacturing is committed to continuing its work in the field of medical technology and to contributing to the advancement of medical science. The company is proud to have played a role in this historic transplant and looks forward to continuing to make a difference in the lives of patients around the world.
About Berkshire Sterile Manufacturing:
Berkshire Sterile is a state-of-the-art fill finish contract manufacturer that is specialized in sterile filling of vials, syringes, and cartridges for biotech and pharmaceutical industries. BSM also offers terminal steam sterilization of syringes, specialty filling, and lyophilization of vials all within isolators. Analytical support, stability studies, lyophilization development, formulation development, and method development are also offered. For more information, please visit the company’s website (https://berkshiresterilemanufacturing.com/) or contact them at email@example.com.
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