Fabricação de GMP de vacina de partículas semelhantes a vírus (VLP)

• Explicado

  Como as vacinas VLP são fabricadas? Esse processo pode ser tão pequeno quanto os cientistas juntando proteínas e DNA em um grande tanque, mais ou menos. Essas proteínas e DNA são essencialmente os materiais que ajudam a formar essa casca semelhante a um vírus. Depois disso, eles despejam das máquinas as minúsculas cápsulas em formato de vírus. Requisitos específicos de equipamento, atenção precisa aos detalhes para uma execução adequada.

• O processo de fabricação de vacinas VLP

  Depois que as cascas são criadas, os cientistas colocam algumas coisas que ajudam seu corpo a saber como combater os germes. Esses ingredientes extras são cruciais porque educam o sistema imunológico. As cápsulas acabam em frascos, pequenos frascos dos quais são expedidas como vacinas. Isto significa que a vacina é entregue contendo exatamente VLP suficiente para que os humanos sejam capazes de desenvolver proteção quando a receberem.

• Vacinas VLP e o futuro da prevenção de doenças infecciosas

  ///As VLPs podem não ser perfeitas, mas isso impede os cientistas de tentar transformá-las em armas. Eles querem garantir a sua própria segurança, bem como o seu funcionamento para manter os indivíduos saudáveis. A tecnologia VLP e as GMP permitem-nos produzir vacinas seguras e eficazes. À medida que aprendemos mais sobre a prevenção de doenças, estudos como estes são essenciais para otimizar as vacinas.

Por que escolher a fabricação de vacinas GMP com partículas semelhantes ao vírus Yaohai (VLP)?

• Conhecimento Profissional e Ampla Experiência

  Yaohai Bio-Pharma is a leading Microbial biologics CDMO. We have been focused on microbial-produced therapeutics and vaccines for human, veterinary, and the management of pet health. We are equipped with Virus-like Particle (VLP) Vaccine GMP Manufacturing RD platforms as well as manufacturing technology that encompass the entire process beginning with the development of microbial strains cells, methods and processes, to commercial and clinical manufacturing which ensures successful implementation of cutting-edge solutions. We have acquired a large amount of experience in bio processing of microbial cells. We have delivered over 200 global projects, and help our clients with navigating the laws from the US FDA, EU EMA, Australia TGA, and China NMPA. Our professional expertise and extensive experience allows us to quickly respond to market demands and provide tailored CDMO services.

• Personalização, eficiência e relação custo-benefício

  Yaohai Bio-Pharma has experience in the production of biologics created from Virus-like Particle (VLP) Vaccine GMP Manufacturing. We offer customized RD and manufacturing solutions while making sure that there are no risks. We have been involved in diverse modalities such as subunit vaccines recombinant, peptides hormones, cytokines, growth factors, single-domain antibodies enzymes, plasmid DNA MRNA, and many more. We are a specialist in many microorganisms, including yeast extracellular and intracellular secretion (yields up to 15g/L) as well as bacteria intracellular soluble and inclusion body (yields as high as 10g/L). We have also created a BSL-2 fermentation platform to create bacterial vaccines. We focus on improving processes, increasing product yields, and reducing production costs. Utilizing a strong technology team, we can ensure prompt and reliable project delivery that will bring your product to market faster.

• Cadeia de suprimentos robusta e capacidades de fabricação

  Virus-like Particle (VLP) Vaccine GMP Manufacturing is a Top 10 biotech company specializing in microbiological fermentation. We have built a modern facility with strong RD capabilities and modern manufacturing facilities. Five production lines for pharmaceuticals in line with GMP standards for microbial purification and fermentation along with two automated fill and finish lines for vials and cartridges and pre-filled needles are available. The fermentation scales available are 100L, 500L, 1000L, to 2000L. Specifications for filling vials range from 1ml up to 25ml. the pre-filled syringes and cartridge filling specifications cover between 1-3ml. The workshop for production is cGMP compliant, and guarantees a stable supply of commercial products and clinical samples. Our factory produces large molecules that are shipped around the world.

• Sistema de Qualidade e Conformidade Regulatória Global

  Yaohai BioPharma, a top 10 Microbial CDMO that integrates quality management and regulatory affairs. Our quality system that is compliant with current GMP standards as well as international regulations. Our team of regulatory experts is proficient in global regulatory frameworks to accelerate biological launches. We ensure traceable production procedures quality products, as well as conformity with the requirements of the Virus-like Particle (VLP) Vaccine GMP Manufacturing and EU EMA. Australia TGA and China NMPA are also met. Yaohai BioPharma successfully passed an in-person audit conducted by a Qualified Person of the European Union (QP) to examine our GMP system and production facility. We also completed the initial certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.

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