DNAワクチン製造 日本

• DNAベースのソリューション

  科学者は DNA ワクチンをどのように作るのでしょうか? 科学者は、利用したい遺伝子を細菌から見つけます。まず、それはほんの短い DNA です。細菌の正しい部分を選択し、免疫システムがそれを識別できるようにする必要があるため、非常に細心の注意を要するプロセスです。まず、その DNA をコピーし、プラスミドと呼ばれるツールに挿入します。(プラスミド = 郵便トラックのようなもの): これは、DNA が細胞に入り込むのに役立ちます。

• DNAワクチンが公衆衛生に大きな影響を与えている理由

  プラスミドは細胞に挿入されます。細胞はDNAを複製し、多数のコピーを作成します。これらの訓練されたコピーからすぐにワクチンが作られます。その結果、研究者は一度に大量のワクチンを作ることができ、この大量生産能力はより多くの人々を助けることができることを意味します。

• DNAワクチンの製造プロセス

  最後に、ワクチンは安全性と有効性を確認するために厳しいテストを受けます。 すべきこと: 科学者はこれらのテストを実施して、製品の安全性と有効性を確認します。 すべてのテストで良好な結果が出れば、科学者はワクチンを大量に製造してすべての人に配布することができます。 その結果、人々はワクチンを接種して健康になることができます。

Yaohai DNA ワクチン製造を選ぶ理由は何ですか?

• 専門知識と豊富な経験

  Yaohai Bio-Pharma, a leader in DNA Vaccine Manufacturing of microbial biologics, is located in Jiangsu. We are focusing on microbially produced therapeutics and vaccines that are suited for human, veterinary, and pet health management. We have modern RD as well as manufacturing technology platforms that cover the entire process, from engineering microbial strains, cell banking, process and method development, through to commercial and clinical manufacturing, making sure that we can ensure the successful supply of the most cutting-edge solutions. We have acquired a large amount of experience in the microbial bio processing field. More than 200 projects have been completed successfully and we support our clients in overcome regulations such as those of the US FDA and EU EMA. We also aid them with Australia TGA and China NMPA. We are able to respond rapidly to market requirements and offer customized CDMO services thanks to our experience and expertise.

• カスタマイズ、効率性、コスト効率

  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 DNA 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.

• 品質システムとグローバル規制コンプライアンス

  Yaohai BioPharma, a top 10 DNA Vaccine Manufacturing, combines regulatory affairs and quality control. We have a quality system that is compliant with current GMP standards and regulations around the globe. Our regulatory team has deep understanding of world-wide regulatory frameworks. This lets us accelerate biological launches. We ensure traceable production procedures with high-quality products as well as compliance with the regulations of the US FDA and EU EMA. Australia TGA and China NMPA is also fulfilled. Yaohai BioPharma successfully passed an in-person audit conducted by an accredited Qualified Person of the European Union (QP) to examine our GMP system and production facility. We have also passed the initial certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.

• 強力なサプライチェーンと製造能力

  Yaohai Bio-Pharma, a top 10 manufacturer of biological products, specializes in microbial fermentation. We have built a modern facility with robust RD capabilities and advanced equipment. We have five drug substance manufacturing lines that conform to GMP requirements for microbial fermentation and purification. We also have two automated fill-finish lines for cartridges, vials and pre-filled syringes. The fermentation scales available for use range from DNA Vaccine Manufacturing to 2000L. The specifications for the filling of a vial range from 1ml up to 25ml. pre-filled syringe or cartridge filling specifications range from approximately 1-3ml. Our cGMP-compliant production facility ensures constant supply of clinical sample as well as commercial items. Our plant produces big molecules which are shipped to the globe.

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