Fabricação de plasmídeo AAV

• Embalagem confiável de AAV para entrega eficaz de genes

  This machine is a packaging cell line for delivering these plasmids to a specific target site, same with Yaohai's Biofabricação de análogos de insulina recombinante. This cell line which is grown in the lab has everything it requires to efficiently package an array of AAV plasmids into AAV viruses. Scientists then use the AAV plasmids to transfer cell line and in response they manufacture their own stock of AAV viruses. After the viruses are fabricated they can be harvested and purified to ensure that endotoxin levels remain low enough for use in gene therapy.

• Tecnologias avançadas usadas na produção de plasmídeos AAV

  Chromatography is another common technology, along with the Processo de Redobramento Corporal de Inclusão produced by Yaohai. Here is an introduction to another kind of column chromatography. This technique is used for separating molecules in solution. In all cases scientists purify their AAV plasmids and viruses. They do this by performing chromatography to remove other unwanted elements of the sample. In the case above it was LF. This is done before being used in gene-therapeutic applications.

• Fabricação econômica de vetores AAV para ensaios clínicos

  There are several methods being explored to make manufacturing more cost effective, as well as the Yaohai's Gene repórter mRNA. One strategy is to utilize another bacteria strain for creation of AAV plasmids notwithstanding the regular and more costly. 

Por que escolher a fabricação de plasmídeo Yaohai AAV?

• Conhecimento Profissional e Ampla Experiência

  Yaohai Bio-Pharma is a leading in AAV Plasmid 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 manufacturer of biological products, specializes in microbial fermentation. We have created a AAV Plasmid Manufacturing manufacturing facility with robust RD capabilities and cutting-edge manufacturing facilities. Five drug substance production lines conforming to GMP standards to purify and ferment microbial cells, as well as two fill and finish lines for vials and cartridges, as well as needles that are pre-filled, are available. The available fermentation scales include 100L, 500L, 1000L and 2000L. Specifications for filling vials range from 1ml - 25ml. the pre-filled cartridge or syringe filling specifications range from between 1-3ml. The production workshop is cGMP-compliant and provides a stable supply of commercial products and clinical samples. Our facility produces large molecules that are shipped worldwide.

• Personalização, eficiência e relação custo-benefício

  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 AAV Plasmid Manufacturing. 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 Qualidade e Conformidade Regulatória Global

  Yaohai BioPharma is a Top 10 Microbial CDMO that integrates quality management and regulatory affairs. We have a quality management system that is in compliance with current AAV Plasmid Manufacturing and regulations around the globe. Our regulatory team is knowledgeable in the global regulatory frameworks that help accelerate biological launches. We ensure traceable production procedures quality products, as well as in compliance with the guidelines of the US FDA and EU EMA. Australia TGA and China NMPA are also in compliance. Yaohai BioPharma has successfully passed the on-site audit by the European Union's qualified Person (QP) for our GMP quality system and production site. We also successfully cleared the first certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.

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