GLP-1アナログ製造 日本

• 患者の転帰改善のための GLP-1 アナログの効率的な製造

  3D プリントは非常に興味深い技術で、GLP-1 医薬品の開発にも使用されています。この新しい技術により、メーカーは製造に使用する機械の独自のコンポーネントを製造できるようになりました。メーカーは、カスタムメイドの部品を使用することで、機械が適切に機能し、患者のニーズに合わせた高品質の医薬品を製造していることを保証できます。

• カスタマイズされた治療計画のためのカスタマイズされた GLP-1 アナログ製造

  サプライ チェーン管理の強化: 効率性の向上を推進するもう 1 つの重要な要素は、サプライヤーとの緊密な関係を維持し、必要な原材料や資材がすべて必要な時間までに目的地に届けられるようにすることです。これにより、生産の中断が少なくなり、最も必要なときに医薬品をすぐに利用できるようになります。

• より環境に優しい未来のための持続可能な GLP-1 アナログ製造方法

  これは、製造プロセスにおけるエネルギー消費を削減することで持続可能になる方法の 1 つです。医薬品の製造に必要な機械やプロセスで使用されるエネルギーを削減する方法を見つける必要があります。たとえば、製造業者は、この目標を達成するために、ソーラー パネルやより効率的な機械を設置することでエネルギー消費を削減できます。

Yaohai GLP-1 アナログ製造を選ぶ理由は何ですか?

• 強力なサプライチェーンと製造能力

  Yaohai Bio-Pharma, a top 10 producer of GLP-1 Analog Manufacturing, 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 has experience in manufacturing biologics that are created from microorganisms. We offer bespoke RD solutions as well as manufacturing services while minimising potential risks. We have worked with diverse techniques, such as recombinant cellular subunits, vaccines (including peptides), growth factors, hormones, and the GLP-1 Analog Manufacturing. We are a specialist in many microorganisms like yeast extracellular and intracellular secretion (yields up to 15g/L) and bacteria intracellular soluble, and inclusion body (yields up to 10g/L). We have also developed a BSL-2 fermentation platform to create bacterial vaccines. We have a track record of improving production processes, thereby increasing yields and reducing costs. We have a highly-efficient technology team to ensure timely and high-quality delivery of projects. This helps us bring your products that are unique faster to the 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 is a Top 10 Microbial CDMO that incorporates quality management and regulatory issues. We have developed a solid quality management system that conforms to the current GMP standards and regulations globally. Our regulatory team has an in-depth understanding of the world-wide regulatory frameworks. This allows us to accelerate biological launches. We ensure traceable production processes as well as high-quality products and in compliance with the guidelines of the US FDA and EU EMA. GLP-1 Analog Manufacturing and China NMPA are also satisfied. Yaohai BioPharma successfully passed an on-site audit conducted by an accredited Qualified Person of the European Union (QP) to review our GMP system and production facility. We have also been through the first certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.

• 専門知識と豊富な経験

  Yaohai Bio-Pharma is a leading microbiological CDMO. Our focus has been on microbially produced GLP-1 Analog Manufacturing and vaccines for human, veterinary and the management of pet health. We have state-of-the-art RD platforms and manufacturing methods which cover the entire procedure starting with microbial strain creation and cell banking, to process and method development to commercial and clinical production and implementation of cutting-edge solutions. Over the years we have gained vast expertise in bio processing using microbial sources. We have successfully delivered over 200 projects across the globe and have assisted our clients with navigating the regulations from the US FDA, EU EMA, Australia TGA, and China NMPA. We are able to react rapidly to market requirements and offer a customized CDMO services due to our expertise and knowledge.

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