Biofabricación de insulina humana

• Técnicas pioneras en biofabricación de insulina humana

  Las instalaciones que producen insulina tienen reglas estrictas además de procedimientos de control de calidad, prohibiendo, por ejemplo, prácticas inseguras que serían peligrosas no sólo para la salud humana sino también para el medio ambiente. Estas precauciones de seguridad incluyen el uso de herramientas especiales: usar ropa protectora que ayude a mantener seguros a todos los que realizan su trabajo. Es importante garantizar que tanto las personas que producen insulina como su entorno estén protegidos.

• Control de calidad y medidas de seguridad en la biofabricación de insulina humana

  Una forma de abordar esto es producir algo llamado insulina biosimilar. Una insulina biosimilar es similar a la insulina de marca (referencia), pero tiene un precio más económico. Lo que se traduce en un mayor porcentaje de personas en el mundo que obtienen la insulina básica que necesitan, incluso aquellos en lugares donde no hay dinero para ese tipo de cosas.

• Satisfacer la demanda mundial de tratamientos asequibles para la diabetes

  Pero la producción de insulina biosimilar no está tan desarrollada. Quizás lleve más tiempo, pero se han realizado esfuerzos en esta dirección, junto con ideas modernas sobre cómo reducir aún más el coste de producir insulina. Dan origen a nuevos medios para producir insulina y están aliados con organizaciones que se asocian para la distribución de insulina en comunidades de regiones donde se ha demostrado que es muy vital. Se trata de una labor muy importante para garantizar que todos los que necesitan insulina puedan permitírsela sin sufrir dificultades financieras insuperables.

¿Por qué elegir la biofabricación de insulina humana Yaohai?

• Experiencia profesional y amplia experiencia

  Yaohai Bio-Pharma, a leader in CDMOs for microbial biologics, is located in Jiangsu. We are focusing on microbially produced therapeutics and vaccines that are Human Insulin Biomanufacturing for human, veterinary as well as pet health management. We have the most cutting-edge RD platforms as well as manufacturing technology that cover the entire manufacturing process, from microbial strain development, cell banking, process and method development to clinical and commercial manufacture which ensures successful production of novel solutions. We have gained an extensive amount of experience in bio processing of microbial cells. More than 200 projects have been successfully completed, and we support our clients in get through regulations, such as those of US FDA as well as EU EMA. We also aid them with Australia TGA and China NMPA. Our experience and professional knowledge as well as our extensive knowledge allow us to quickly respond to market demands and provide customized CDMO services.

• Cadena de suministro y capacidades de fabricación sólidas

  Yaohai Bio-Pharma, a top 10 producer of biological products, is a specialist in microbial fermentation. We have established an advanced facility that is equipped with modern facilities and strong RD manufacturing capabilities. We have five drug substance manufacturing lines that are in compliance with GMP requirements for microbial fermentation and purification, as well as two fill-finish lines that are automated for cartridges, vials, as well as pre-filled syringes. The available fermentation scales vary from 100L to 500L, 1000L and 2000L. Human Insulin Biomanufacturing for vias are 1ml to 25ml, whereas the pre-filled syringes and cartridge filling specifications cover 1-3ml. Our production workshop is cGMP compliant and guarantees steady supply of clinical samples as well as commercial items. Our plant produces large molecules which are shipped to the globe.

• Personalización, eficiencia y rentabilidad

  Yaohai Bio-Pharma has experience in manufacturing biologics that are created from microorganisms. We offer bespoke RD solutions as well as manufacturing services while minimising potential risks. We have worked with diverse techniques, such as recombinant cellular subunits, vaccines (including peptides), growth factors, hormones, and the Human Insulin Biomanufacturing. We are a specialist in many microorganisms like yeast extracellular and intracellular secretion (yields up to 15g/L) and bacteria intracellular soluble, and inclusion body (yields up to 10g/L). We have also developed a BSL-2 fermentation platform to create bacterial vaccines. We have a track record of improving production processes, thereby increasing yields and reducing costs. We have a highly-efficient technology team to ensure timely and high-quality delivery of projects. This helps us bring your products that are unique faster to the market.

• Sistema de Calidad y Cumplimiento Normativo Global

  Yaohai BioPharma, a Human Insulin Biomanufacturing Microbial CDMO, integrates regulatory affairs and quality management. We have a quality system that is compliant with current GMP standards, as well as regulations around the globe. Our regulatory team is knowledgeable in global regulatory frameworks to expedite biological launches. We make sure that production processes are traceable, high-quality products, and complying with the rules of the US FDA and EU EMA. Australia TGA and China NMPA is also fulfilled. Yaohai BioPharma has successfully passed the audit on site of the European Union's Qualified Person (QP) to ensure our GMP quality system and production site. We also have passed the initial certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.

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