Fabricação de vacinas baseadas em VLP

• Fabricação segura, eficaz e escalonável

  VLP vaccines - VPP begins with construction of a small virus-like particle in the lab. But fear not, because these particles are NOT contagious to humans! Scientists insert tiny bits of the germs that these vaccines will provide protection which is also known as VLPs. 

• Processo de vacina baseado em VLP

  As vacinas VLP são um avanço no campo da ciência das vacinas. Podem ser produzidos em grande escala de forma rápida e fácil, para que estejamos mais bem equipados para proteger as pessoas em tempos de emergência ou quando surge uma doença. Eles também são bons em nos manter bem protegidos de doenças! Isto é ainda mais verdadeiro hoje, quando os germes parecem evoluir quase da noite para o dia.

• Aumentando a imunidade com vacinas baseadas em VLP – um futuro promissor

  A tecnologia VLP também pode ser associada a novas tecnologias (como o mRNA usado nas vacinas contra a covid). O mRNA é um tipo de material genético que dá instruções ao corpo. Juntamente com o mRNA, a utilização de VLPs permite aos investigadores desenvolver uma vacina para ensinar o nosso corpo a combater os germes de forma mais eficaz. Combine, você obtém vacinas mais potentes e com menor probabilidade de falhar.

Por que escolher a fabricação de vacinas baseada em Yaohai VLP?

• Sistema de Qualidade e Conformidade Regulatória Global

  Yaohai BioPharma is a Top 10 Microbial CDMO that incorporates quality control and regulatory matters. We have a quality system which is in line with current GMP standards and international regulations. Our regulatory team is knowledgeable in global regulatory frameworks to accelerate biological launches. We ensure traceable manufacturing processes and top-quality products that are compliant with the requirements of the US FDA, EU EMA, Australia TGA, and VLP-based Vaccine Manufacturing. Yaohai BioPharma has successfully passed the audit on site of the European Union's qualified Person (QP) for our GMP quality system and production site. In addition, we've cleared the first certification audits of the ISO9001 Quality Management System, ISO14001 Environmental Management System, and ISO45001 Occupational Health and Safety Management System.

• Conhecimento Profissional e Ampla Experiência

  Yaohai Bio-Pharma is a leading in VLP-based Vaccine Manufacturing CDMO. Our main focus has been the production of microbial vaccinations and therapeutics to treat pets, human and veterinary health. We possess cutting-edge RD and manufacturing technology platforms that cover the entire manufacturing process from the engineering of microbial strains, to cell banking processing and method design to clinical and commercial manufacturing, making sure that we can ensure the successful delivery of the most advanced solutions. We have accumulated a huge quantity of knowledge in the bio processing microbial field. More than 200 projects have been successfully completed and we help our clients comply with regulations like those of the US FDA as well as EU EMA. We also help them to navigate Australia TGA and China NMPA. We are able to respond rapidly to market requirements and offer customized CDMO services due to our experience and expertise.

• Cadeia de suprimentos robusta e capacidades de fabricação

  Yaohai Bio-Pharma, a top 10 VLP-based Vaccine Manufacturing of biological products, is a specialist in microbial fermentation. We have set up a modern facility that has robust RD capabilities and advanced infrastructure. Five lines of production for drugs conforming to GMP standards to purify and ferment microbial cells along with two fill and finish lines for vials as well as cartridges and needles pre-filled are readily available. The fermentation scales available for use range from 100L to 2000L. Filling specifications for vias are 1ml to 25ml, whereas pre-filled syringe or cartridge filling requirements are between 1-3ml. The production workshop is cGMP certified and offers the availability of commercial and clinical samples. The large molecules manufactured in our facility are available for delivery worldwide.

• Personalização, eficiência e relação custo-benefício

  Yaohai Bio-Pharma has experience in the manufacture of biologics derived from microorganisms. We offer tailored RD solutions and manufacturing while minimizing the risk. We have worked with diverse methods, such as VLP-based Vaccine Manufacturing of vaccines (including peptides), growth factors, hormones, and Cytokines. We specialized in multiple microbial hosts, including yeast extracellular and intracellular (yield up to 15 g/L) bacteria periplasmic secretion, soluble intracellular, and inclusion bodies (yield up to 10 grams/L). We also have a BSL-2 fermentation platform to create bacterial vaccines. We specialize in improving processes, increasing product yields, as well as reducing production costs. We have an efficient technology team that guarantees timely and quality project delivery. This allows us to deliver your exclusive products quicker to market.

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