VLP発酵および精製プロセス 日本

• VLP発酵がバイオ医薬品製造に革命をもたらす

  VLP は、ガンからインフルエンザまで、さまざまな病気の治療に役立つと考えられています。ウイルスを模倣することで、VLP は私たちの体がウイルスを認識し、病気にならないようにする練習をします。これは、人類の大部分を苦しめているこれらの病気すべてにおいて、私たち自身を改善するためのツールを与えてくれるので、とても興味深いことです。

• 発酵と精製プロセスの簡易ガイド

  しかし、VLP を作るのは簡単なことではありません。そのためには、VLP を適切な形に作らなければならず、そうして初めて薬として使えるようになります。そして、まさにここで発酵の技術が活かされます。現在、バイオ医薬品企業は発酵を通じて前例のない規模で VLP を生産しており、手頃な価格で治療薬を生産することを目指しています。

• 「VLP 制作の旅」。

  科学者が最初に決めなければならないのは、発酵にどの微生物を使うかということです。また、どの栄養素がそれらの微生物の繁殖を助け、理想的な VLP を生産するかも特定する必要があります。ちょうどレシピに適切な材料を選ぶようなものです。

Yaohai VLP発酵および精製プロセスを選択する理由は何ですか?

• 専門知識と豊富な経験

  Yaohai Bio-Pharma, a leader in CDMOs of microbial biologics, is headquartered in Jiangsu. We have been focused on microbially produced therapeutics and vaccines that are suited for human, veterinary and the management of VLP Fermentation and Purification Process. We have the most the most advanced RD as well as manufacturing technology platforms, which cover the entire process from Microbial strain engineering, cell banking as well as process and method development to commercial and clinical manufacturing, assuring the successful supply of the most cutting-edge solutions. We have accumulated a huge amount of experience in the bio processing of microbial cells. We have delivered over 200 projects across the globe and have assisted our clients with navigating the rules and regulations of the US FDA, EU EMA, Australia TGA, and China NMPA. Our expert knowledge and vast experience enable us to swiftly adapt to market needs and offer tailored 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 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 Fermentation and Purification Process. 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.

• 強力なサプライチェーンと製造能力

  Yaohai Bio-Pharma, a top 10 producer of VLP Fermentation and Purification Process, specializes in microbial fermentation. We have set up a modern facility with advanced facilities as well as robust RD manufacturing capabilities. Five production lines for drug substances complying with GMP standards for microbial purification and ferment along with two automated fill and finish lines for vials as well as cartridges as well as pre-filled needles are readily available. The available fermentation scales range between 100L and 2000L. Vial filling specifications cover 1ml - 25ml. the pre-filled cartridge or syringe filling specifications are between 1-3ml. The production workshop is cGMP certified and offers the availability of commercial and clinical samples. Our plant produces big molecules that are exported to all over the world.

• カスタマイズ、効率性、コスト効率

  Yaohai Bio-Pharma is experienced in the development of microbial-derived biologics We offer tailored RD solutions and manufacturing while keeping risks to a minimum We have used a variety of modalities including recombinant subunits vaccines (including peptides) growth factors hormones and Cytokines We've specialized in several microorganisms like yeast intracellular and extracellular secretion (yields up to 15g/L) and bacteria intracellular soluble and inclusion body (yields as high as 10g/L) We have also created a VLP Fermentation and Purification Process fermentation system to develop bacteria-based vaccines We are experts in optimizing processes increasing yields as well as reducing production costs Utilizing a strong technology team we ensure timely and quality project delivery to bring your exclusive products to market faster

関連商品カテゴリー

探しているものが見つかりませんか?
その他の利用可能な製品については、コンサルタントにお問い合わせください。