GLP-1アゴニスト製造 日本

• 革新と進歩

  この研究分野では、長年にわたり多くの新しい改良や概念が開発されてきました。たとえば、OT は GLP-1 薬の効果を高めるために継続して行われています。大きな利点の 1 つは、これらの GLP-XNUMX 薬の多くは半減期がはるかに長いことです。これにより、服用頻度も減り、糖尿病管理がより目立たなくなります。

• GLP-1作動薬製造における品質管理と安全対策

  当然のことながら、GLP-1 薬は安全で、必要とする人々に効果を発揮するものでなければなりません。また、これらの薬が製造されている場所自体が国家品質基準に準拠しているかどうかを確認するために、注意深い監視、テスト、検査のシステムも導入されています。これは、薬のすべてのバッチが必要な安全レベルを満たしていることを確認するためです。

• 糖尿病管理の重要な貢献者

  薬を作る原料となる生薬も、期待通りの品質で、十分な純度があるかテストされます。製造のさまざまな段階でチェック/ベンチテストを実施することで、一貫性のあるお菓子を製造し、安全に摂取できることを確認できます。これは、物事が正しく安全に機能することを少しでも確信できる品質基準を維持するために、ほとんどのベストプラクティスが機能する方法と一致しています。

Yaohai GLP-1 アゴニスト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. We have been focused on microbial-produced therapeutics and vaccines for human, veterinary, and the management of pet health. We are equipped with GLP-1 Agonist Manufacturing RD platforms as well as manufacturing technology that encompass the entire process beginning with the development of microbial strains cells, methods and processes, to commercial and clinical manufacturing which ensures successful implementation of cutting-edge solutions. We have acquired a large amount of experience in bio processing of microbial cells. We have delivered over 200 global projects, and help our clients with navigating the laws from the US FDA, EU EMA, Australia TGA, and China NMPA. Our professional expertise and extensive experience allows us to quickly respond to market demands and provide tailored CDMO services.

• カスタマイズ、効率性、コスト効率

  Yaohai Bio-Pharma is GLP-1 Agonist 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.

• 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 GLP-1 Agonist 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 GLP-1 Agonist 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.

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