GMP CMV抗原製造 日本

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  疾病予防の改善に向けた GMP CMV 抗原製造の進歩

  私たちはワクチンや治療法の開発に向けて研究、実験、革新を続けており、ヤオハイの製品も GMP 抗 PD-1PD-L1 VHH. Additional, we are working hard on developing new tools and technologies to enable us to design personalized therapies for patients. We are looking at some incredible new immuno therapies that have the potential to make life saving impacts and revolutionise the treatment of many diseases.

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  高品質で一貫性のある生物製剤の提供

  バイオ医薬品、つまり生きた細胞から作られる医薬品は非常に複雑な製品であり、各バッチが同一であり、非常に高い品質基準を満たしていることを保証するために、厳格なガイドラインに従って製造する必要があります。 Yaohaiでは、最高品質の医薬品を常に生産できる最先端の技術と製造ソリューションを提供するよう努めています。ここでGMPの実践が役立ち、製造した医薬品の各バッチが、必要に応じて使用できるほど純粋で強力であることを確認しています。 VLP がんワクチン製造 Yaohaiより。

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  パーソナライズされたヘルスケアソリューションのための GMP CMV 抗原製造

  パーソナライズされたヘルスケアの概念は、患者の遺伝子、薬理遺伝学プロファイル（遺伝情報に基づいて人が薬をどのように処理するかを示す）などを使用して各患者に合わせて設計された治療法に関するイノベーションとして始まりました。これは、ヤオハイの VLP生産のための大腸菌発酵. GMP makes it possible for us to generate personalized immuno therapies that will help combat these major diseases.

Yaohai GMP CMV 抗原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 is a leading microbial biologics CDMO. Our main focus has been the production of GMP CMV Antigen Manufacturing and therapeutics to treat pets, human and veterinary health. We have state-of-the-art RD platforms and manufacturing technology that cover the entire manufacturing process beginning with the development of microbial strains Cell banking, process and method development, through commercial and clinical manufacture that ensures the successful delivery of innovative solutions. Over time we've gained a vast knowledge of microbial-based bio processing. We have successfully completed more than 200 global projects, and help our clients with navigating the rules and regulations of the US FDA, EU EMA, Australia TGA, and China NMPA. We are able to react promptly to market demands and provide tailored CDMO services due to our experience and expertise.

• 品質システムとグローバル規制コンプライアンス

  GMP CMV Antigen Manufacturing is a Top 10 Microbial CDMO that incorporates quality control and regulatory matters. We have established a robust quality system that complies with the current GMP standards and regulations all over the world. Our regulatory team is well-versed on global regulatory frameworks to speed up biological launches. We guarantee traceable production processes and top-quality products that are compliant with the rules of US FDA, EU EMA, Australia TGA, and China NMPA. Yaohai BioPharma successfully passed an audit on site conducted by an accredited Qualified Person from the European Union (QP) to review our GMP system and production facility. Additionally, we've passed the first certification audits of the ISO9001 Quality Management System, ISO14001 Environmental Management System, and ISO45001 Occupational Health and Safety Management System.

• カスタマイズ、効率性、コスト効率

  Yaohai Bio-Pharma is GMP CMV Antigen Manufacturing in microbial-derived biologics. We offer custom RD as well as manufacturing solutions, while minimising the risk. We've been involved in numerous modalities like recombinant subunit vaccines, peptides hormones, cytokines growth factors, single-domain antibodies, enzymes, plasmid DNA, the mRNA, and other. We are experts in several Microbial hosts, such as yeast extracellular and intracellular (yield up to 15 grams per liter) bacteria periplasmic secretion as well as soluble intracellular inclusion bodies (yield up to 10 grams/L). Additionally, we have developed the BSL-2 microbial fermentation platform for the development of bacterial vaccines. We have a track record of improving production processes, thereby increasing yields, and reducing costs. With a highly efficient technology team, we guarantee prompt and reliable project delivery and bring your products to market quicker.

• 強力なサプライチェーンと製造能力

  Yaohai Bio-Pharma, a top 10 GMP CMV Antigen 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.

関連商品カテゴリー

• AAVプラスミド製造
• プラスミドDNAの分析方法
• バクテリオファージ AP205 VLP 製造
• バクテリオファージQ VLP製造
• キメラVLPワクチン製造
• 結合VLPワクチン製造
• DNAワクチン製造
• VLP生産のための大腸菌発酵
• GLP-1アゴニスト製造
• GLP-1アナログ製造

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