DARMSTADT, Alemania, mayo de 2021 – Para cubrir la alta demanda de lípidos, un componente clave de las vacunas y terapias basadas en ARNm, Merck, una empresa líder en ciencia y tecnología, ha lanzado un nuevo producto de colesterol sintético de alta pureza, nueve meses antes de lo previsto.
“Aprovechando la experiencia de dos décadas en el desarrollo y fabricación de lípidos de alta calidad, diseñamos un proceso patentado para llevar nuestro nuevo producto de colesterol sintético SAFC® al mercado casi un año antes”, destacó Andrew Bulpin, director de Soluciones de Procesos, Ciencias de la Vida, en Merck. “Con la introducción de nuestro nuevo producto de colesterol sintético SAFC®, hemos aumentado nuestra capacidad en 50 veces, ayudando a los biofabricantes a llevar terapias que salvan vidas a los pacientes más rápido”.
Merck fabrica lípidos en Schaffhausen, Suiza; Darmstadt, Alemania; y St. Louis, Missouri, EE. UU. Si bien existen versiones de colesterol sintético y de origen animal disponibles en el mercado, el producto de colesterol sintético de Merck ofrece alta pureza, escalabilidad y calidad constante.
Este lípido neutro, utilizado en productos comercializados, tiene una pureza superior al 99 por ciento; ofrece una alta consistencia de lote a lote y es escalable bajo GMP comercial. Merck es una de las pocas empresas del mundo capaz de producir las cantidades necesarias para la fabricación de nanopartículas lipídicas y cumplir con los requisitos de calidad para la terapéutica de ARNm.
El lanzamiento de este nuevo producto sigue a la adquisición por parte de la compañía de AmpTec, una organización de fabricación y desarrollo de contratos de ARNm con sede en Hamburgo, Alemania. Al combinar la tecnología de ARNm basada en PCR de AmpTec con la amplia experiencia de Merck en la fabricación de lípidos, Merck puede proporcionar una oferta verdaderamente integrada en toda la cadena de valor de ARNm. Merck tiene más de 20 años de experiencia en el desarrollo y fabricación de lípidos de alta calidad, siguiendo los procesos GMP. La compañía ofrece apoyo regulatorio a través de todas las fases del desarrollo clínico y la comercialización, así como una profunda experiencia analítica.
Merck está colaborando con más de 50 empresas para respaldar sus esfuerzos en el desarrollo y producción de vacunas y tratamientos Covid-19, proporcionando lípidos personalizados, así como otras materias primas críticas, equipos de procesamiento y servicios utilizados en la fabricación de medicamentos de ARNm y vacunas. A principios de febrero de 2021, la compañía anunció la extensión de su asociación estratégica con BioNTech para acelerar significativamente el suministro de lípidos que se necesitan con urgencia y aumentar las cantidades que se entregarán hacia finales de 2021. Los lípidos se utilizarán para la producción de la vacuna Pfizer-BioNTech Covid-19.
La compañía anunció recientemente la incorporación de una unidad de producción de ensamblaje de un solo uso en su Centro de Ciencias de la Vida en Molsheim, Francia. La compañía también anunció recientemente proyectos de expansión en Darmstadt, Alemania; Cork, Irlanda; Buchs, Suiza; Carlsbad, California; Madison, Wisconsin; Jaffrey, Nueva Hampshire; y Danvers, Massachusetts. En este último sitio, Merck está trabajando para duplicar la capacidad de producción local de un solo uso para fines de 2021. Estas expansiones son parte de un ambicioso programa de varios años para aumentar la capacidad industrial y las capacidades de Merck para respaldar la creciente demanda mundial de medicamentos para salvar vidas y hacer contribuciones significativas a la salud pública.
Todos los comunicados de prensa de Merck se distribuyen por correo electrónico en el mismo momento en que se publican en el sitio web de Merck. Para registrarse, modificar su selección o darse de baja de este servicio, visite www.merckgroup.com/subscribe
Acerca de Merck
Merck, una empresa líder en ciencia y tecnología, opera en los sectores de la salud, las ciencias biológicas y la electrónica. Alrededor de 58.000 empleados trabajan para marcar una diferencia positiva en la vida de millones de personas todos los días creando formas de vida más alegres y sostenibles. Desde el avance de las tecnologías de edición de genes y el descubrimiento de formas únicas de tratar las enfermedades más desafiantes hasta la habilitación de la inteligencia de los dispositivos, la empresa está en todas partes. En 2020, Merck generó unas ventas de 17.500 millones de euros en 66 países. La exploración científica y el espíritu empresarial responsable han sido clave para los avances científicos y tecnológicos de Merck. Así es como Merck ha prosperado desde su fundación en 1668. La familia fundadora sigue siendo la propietaria mayoritaria de la empresa que cotiza en bolsa. Merck posee los derechos globales sobre el nombre y la marca Merck. Las únicas excepciones son los Estados Unidos y Canadá, donde los sectores comerciales de Merck operan como EMD Serono en atención médica, MilliporeSigma en ciencias de la vida y EMD Electronics.
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