VLP生産のための酵母発酵 日本

• 最適な VLP 生産のための酵母発酵の科学を解明

  酵母発酵は VLP を生成できるだけでなく、私たちの体に必要な他の重要なタンパク質や酵素の生成にも役立ちます。一例を挙げると、糖尿病患者にとって不可欠な治療薬であるインスリンは、現在酵母発酵によって生成されています。これは、酵母が幅広いプロジェクトでどのように使用できるか、また多くの業界にどのような用途を提供できるかを示す例にすぎません。

• 次世代VLP製造における重要なコンポーネント

  クローバー氏によると、VLP 製造の最も難しい点の 1 つは、高品質を維持し、毎回正確に同じ量を製造することです。ワクチンとして有効であるためには、VLP の各バッチが一定である必要があります。実際、酵母発酵技術はここ数年で大きく進歩しました。科学者は VLP の生産量を増やすために、プロセスに多くの改良を加えています。酵母が繁殖して大量の VLP を生産するのに適した生育条件を備えた特別な施設が建設されています。

• 酵母発酵を利用して大規模に信頼性の高い VLP 生産を実現する

  VLP は酵母発酵によって継続的に生産されており、科学者たちは完璧さを追求する中で、パイプラインでさらなる改良が行われています。科学者たちは最適な酵母条件を研究し、さまざまな種類の酵母をテストし、ウイルスタンパク質をコードする遺伝子を微調整します。これらの進歩により、VLP はより効率的かつ費用対効果の高い方法で生産されるようになります。これにより、世界中のより多くの人がこれらのワクチンや治療の恩恵を受けることができます。

VLP 製造に Yaohai 酵母発酵を選択する理由は何ですか?

• 強力なサプライチェーンと製造能力

  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. Yeast Fermentation for VLP Production 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.

• 専門知識と豊富な経験

  Yaohai Bio-Pharma is a leading in microbial biologics CDMO. Our main focus has been the production of microbial vaccinations and therapeutics to manage the health of pets, humans and animals. health. We have modern RD and manufacturing technology platforms that cover the entire process, from microbial strain engineering, cell banking, process and method design to commercial and clinical manufacturing, which ensures the success supply of the most cutting-edge solutions. Through the years we have gained vast expertise in using microbial sources. Over 200 projects were successfully completed. In addition, we support our clients in get through regulations, such as those of the US FDA as well as EU EMA. We also help them to navigate Australia TGA and China NMPA. Our expert knowledge and vast experience allow us to quickly respond to market demands and provide Yeast Fermentation for VLP Production CDMO services.

• 品質システムとグローバル規制コンプライアンス

  Yaohai BioPharma is a Top 10 Microbial CDMO that incorporates quality control and Yeast Fermentation for VLP Production. We have developed a solid quality system that adheres to current GMP standards and regulatory requirements worldwide. Our regulatory team is knowledgeable on global regulatory frameworks to expedite biological launches. We make sure that production processes are traceable with high-quality products as well as complying with the rules of the US FDA and EU EMA. Australia TGA and China NMPA are also in compliance. Yaohai BioPharma successfully passed an on-site audit conducted by a Qualified Person from the European Union (QP) to examine our GMP process and manufacturing facility. We also successfully been through the initial certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.

• 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 Yeast Fermentation for VLP Production 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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