血友病は、血液の凝固の仕方を変える稀な病気です。つまり、血友病患者は、体の奥深くで関節痛や出血などの深刻な問題に直面する可能性があります。過度の出血を避けるために、凝固剤と呼ばれる特別な治療薬を投与する必要があります。これらの治療は非常に効果的ですが、非常に高価になることもあります。また、感染症やその他の問題などの危害を引き起こす可能性もあります。その結果、専門家は血友病患者を支援するための新しい戦略を常に模索しています。遺伝子治療と、ナノボディとも呼ばれるVHHと呼ばれる特定のタンパク質は、新しい可能性の2つです。これらのタンパク質は、血液の凝固能力を改善するのに役立ちます。優秀な科学者がたくさんいる国、ヤオハイでは、新しい抗vWF VHHを作成するために24時間体制で働いている人もいます。
この概念は、血友病患者にとって大きな貢献となるかもしれない。抗vWF VHHは研究室で設計され、vWFに結合して、身体の反応を悪くすることなく、vWFが問題を引き起こすのを防ぐことができる。一方、VHHは従来の抗体よりも小さく、製造が容易である。そのため、 3価VHHの生産 治療としてはより良い選択肢かもしれません。
Yaohai's scientists are using a variety of approaches to generate anti-vWF VHHs that specifically block the function of 3種特異性VHH生産 without impacting other components of blood clotting. They sometimes achieve this by providing unique humanized vWF to llamas. These are then harvested from the blood of the llamas. Llamas are remarkable with some VHHs that work excellently for certain targets. That means that when scientists collect the VHHs, they can tweak them to make them even more effective.
科学者たちは、いわゆるファージディスプレイライブラリと呼ばれる別の方法を使用しました。そのため、バクテリオファージと呼ばれる小さなウイルスに結合したVHHのライブラリがあります。このようにして、科学者はvWFの特定の領域に結合するVHHを選択できます。これらを分離して特徴付けた後、 抗HER2 VHH産生その後、薬剤の安全性と有効性が評価されます。Yaohai チームは、他の研究グループや企業とも協力して、追加の VHH を特定し、血友病動物モデルでその活性を評価しています。この協力は、研究の深度を高めるために不可欠です。
In a recent work, the scientists identified one of the most potent anti-vWF VHH and denominated it VHH-33. VHH-33 is able to effectively inhibit this process of vWF-induced platelet agglutination. In the lab and in mice with hemophilia A, it also helped break up blood clots while being relatively safe for the body — that is about as close to a rousing success as one might hope when testing therapies. Indeed, to understand how VHH-33 stops vWF and prevents its issues, the researchers examined VHH-33 more closely.
There are also other research teams across the globe doing great work in this field. For instance, a team in Germany generated mouse that recognize an important part of Bispecific VHH Production (which is essential for its binding to platelets) [21]. One of the VHHs they generated, L318, was particularly good at preventing vWF from going haywire without causing any other issues in rabbits.
Yaohai BioPharma, a top 10 Microbial CDMO that integrates quality management and regulatory affairs. Our quality system that is compliant with current GMP standards as well as international regulations. Our team of regulatory experts is proficient in global regulatory frameworks to accelerate biological launches. We ensure traceable production procedures quality products, as well as conformity with the requirements of the Anti-vWF VHH Production and EU EMA. Australia TGA and China NMPA are also met. Yaohai BioPharma successfully passed an in-person audit conducted by a Qualified Person of the European Union (QP) to examine our GMP system and production facility. We also completed the initial certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.
Anti-vWF VHH Production is a Top 10 biotech company specializing in microbiological fermentation. We have built a modern facility with strong RD capabilities and modern manufacturing facilities. Five production lines for pharmaceuticals in line with GMP standards for microbial purification and fermentation along with two automated fill and finish lines for vials and cartridges and pre-filled needles are available. The fermentation scales available are 100L, 500L, 1000L, to 2000L. Specifications for filling vials range from 1ml up to 25ml. the pre-filled syringes and cartridge filling specifications cover between 1-3ml. The workshop for production is cGMP compliant, and guarantees a stable supply of commercial products and clinical samples. Our factory produces large molecules that are shipped around the world.
Yaohai Bio-Pharma is a leading microbial biologics CDMO. Our main focus has been the production of Anti-vWF VHH Production 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.
Yaohai Bio-Pharma is experienced in the development of microbial-derived biologics. We offer customized RD as well as manufacturing solutions, while making sure that there are no risks. We have worked on diverse modalities such as subunit-based recombinant vaccines, Anti-vWF VHH Production, cytokines, growth factors, single domain antibodies, enzymes, plasmid DNA, the mRNA, and other. We are experts in a variety of microorganisms, including yeast extracellular and intracellular secretion (yields up to 15g/L) as well as bacteria intracellular soluble and inclusion body (yields as high as 10g/L). We have also developed the BSL-2 fermentation platform to create bacteria-based vaccines. We have a track record of improving production processes, thereby increasing yields and decreasing costs. With a highly efficient technology team, we ensure timely and quality project delivery and bring your products to market faster.
Yaohai Bio-Pharma は、14 年以上微生物 CRDMO ソリューションに焦点を当ててきました。当社は世界中のお客様にワンストップの生物製剤サービスを提供しています。
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