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El primer fármaco comercial fabricado a través de la tecnología AJIPHASE de Ajinomoto Bio-Pharma Services recibe la aprobación de la FDA
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Ajinomoto Bio-Pharma Services

Oct 06, 2020, 12:27 ET

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TOKIO, 6 de octubre de 2020 /PRNewswire/ -- Ajinomoto Bio-Pharma Services ("Aji Bio-Pharma"), un proveedor líder de servicios de desarrollo y fabricación contractual de biofarmacéuticos, se complace anunciar que la FDA de EE.UU. ha aprobado el primer fármaco comercial a través del proceso de producción AJIPHASE® patentado de Aji Bio-Pharma.

Originalmente desarrollada por la síntesis de péptido, la tecnología de síntesis AJIPHASE se ha expandido para incluir la producción de oligonucleótidos. Un híbrido de síntesis de fase sólida y fase de solución tradicional, utilizando una fijación en lugar de una resina, AJIPHASE es una plataforma demostrada para el desarrollo y fabricación de cGMP de cantidades de alta calidad y pureza de oligonucleótidos y péptidos.   

"Estamos encantados de poder ofrecer este fármaco a nuestro socio y apoyarles en sus esfuerzos por ofrecer un terapéutico que salva vidas", dijo Wataru Kurosawa, gestor de AJIPHASE Group, Ajinomoto Bio-Pharma Services. "Nuestra tecnología AJIPHASE es un gran ejemplo de Aji Bio-Pharma ofreciendo soluciones fiables e innovadoras a nuestros clientes".

La robusta tecnología es altamente escalable (µg a 200 kg) ofreciendo oligonucleótidos y péptidos altamente rentables y puros, con menos productos de desecho. Cuando la comparamos con la síntesis de fase sólida tradicional, la tecnología AJIPHASE utiliza menos solventes y reactivos, mientras ofrece tamaños de lote de alto rendimiento de alta pureza y calidad equivalente.

"Estamos muy contentos de que nuestra tecnología de síntesis AJIPHASE haya podido cubrir las necesidades de fabricación y calidad para la terapéutica de nuestros clientes", dijo Yasuyuki Otake, director de Japón, Ajinomoto Bio-Pharma Services. "Y ejemplifica nuestra dedicación a mejorar la salud de la humanidad".

Acerca de Ajinomoto Bio-Pharma Services

Ajinomoto Bio-Pharma Services es una organización totalmente integrada de desarrollo y fabricación por contrato con sedes en Bélgica, Estados Unidos, Japón y La India, la cual presta servicios integrales de desarrollo, fabricación de cGMP y llenado y acabado asépticos para las API de moléculas pequeñas y grandes y sus intermediarios. Ajinomoto y Ajinomoto Bio-Pharma Services ofrecen una amplia gama de capacidades y plataformas innovadoras para programas preclínicos y pilotos y hasta cantidades comerciales, que incluyen la tecnología de expresión de proteínas Corynex®, síntesis de oligonucleótidos, conjugaciones de anticuerpos farmacológicos (ADC), uso de las API de alta potencia (HPAPI), biocatálisis, fabricación de flujo continuo y más. Ajinomoto Bio-Pharma Services se dedica a proveer un alto nivel de calidad y servicio para satisfacer las necesidades de nuestros clientes. Si desea conocer más visite la página web: www.AjiBio-Pharma.com

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