ヒトインスリンバイオ製造 日本

• ヒトインスリンのバイオ製造における先駆的技術

  インスリンを製造する施設には、品質管理手順に加えて、人間の健康だけでなく環境にも危険を及ぼすような危険な行為を禁止する厳しい規則があります。これらの安全対策には、特別なツールの使用、作業に従事するすべての人の安全を守る防護服の着用が含まれます。インスリンを製造する人々と環境の両方が保護されていることを確認することが重要です。

• ヒトインスリンバイオ製造における品質管理と安全対策

  この問題に対処する方法の 1 つは、バイオシミラー インスリンと呼ばれるものを製造することです。バイオシミラー インスリンはブランド名 (参照) インスリンに似ていますが、価格が安くなっています。つまり、必要な基本的なインスリンを入手できる割合が世界中で高まるということです。そのようなインスリンを購入する資金がない場所の人々も対象となります。

• 手頃な価格の糖尿病治療に対する世界的な需要に応える

  しかし、バイオシミラーインスリンの生産は、まだ十分には進んでいません。時間がかかるかもしれませんが、インスリン製造コストをさらに削減する最新のアイデアとともに、この方向への取り組みは行われています。彼らは、インスリン製造の新しい方法を生み出し、非常に重要であることが証明されている地域のコミュニティにインスリンを配布するために提携している組織と連携しています。これは、インスリンを必要とするすべての人が、乗り越えられない経済的苦境に陥ることなく、インスリンを買えるようにするための非常に重要な作業です。

Yaohai ヒトインスリンバイオ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, a leader in CDMOs for microbial biologics, is located in Jiangsu. We are focusing on microbially produced therapeutics and vaccines that are Human Insulin Biomanufacturing for human, veterinary as well as pet health management. We have the most cutting-edge RD platforms as well as manufacturing technology that cover the entire manufacturing process, from microbial strain development, cell banking, process and method development to clinical and commercial manufacture which ensures successful production of novel solutions. We have gained an extensive amount of experience in bio processing of microbial cells. More than 200 projects have been successfully completed, and we support our clients in get through regulations, such as those of US FDA as well as EU EMA. We also aid them with Australia TGA and China NMPA. Our experience and professional knowledge as well as our extensive knowledge allow us to quickly respond to market demands and provide customized CDMO services.

• 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. Human Insulin Biomanufacturing 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.

• 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 Human Insulin Biomanufacturing. 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, a Human Insulin Biomanufacturing Microbial CDMO, integrates regulatory affairs and quality management. We have a quality system that is compliant with current GMP standards, as well as regulations around the globe. Our regulatory team is knowledgeable in global regulatory frameworks to expedite biological launches. We make sure that production processes are traceable, high-quality products, and complying with the rules of the US FDA and EU EMA. Australia TGA and China NMPA is also fulfilled. Yaohai BioPharma has successfully passed the audit on site of the European Union's Qualified Person (QP) to ensure our GMP quality system and production site. We also have passed the initial certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.

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