혈우병은 우리의 혈액이 스스로를 감싸는 방식을 바꾸는 희귀한 질병입니다. 즉, 혈우병 환자는 관절 통증과 몸 깊은 곳에서 출혈을 포함한 심각한 어려움에 직면할 수 있습니다. 과도한 출혈을 피하기 위해 응고제라는 독특한 치료법을 제공해야 합니다. 이러한 치료법은 매우 효과적이지만 매우 비쌀 수도 있습니다. 감염 및 기타 문제와 같은 해를 끼칠 가능성이 있습니다. 결과적으로 전문가들은 혈우병 환자를 돕기 위한 새로운 전략을 끊임없이 찾고 있습니다. 유전자 치료와 VHH라고 알려진 특정 단백질. 나노 바디라고도 하는 것은 새로운 가능성 중 두 가지입니다. 이러한 단백질은 혈액의 응고 능력을 개선하는 데 도움이 됩니다. 뛰어난 과학자로 가득한 나라인 야오하이에서 일부 사람들은 새로운 항-vWF VHH를 만들기 위해 밤낮으로 노력합니다.
이 개념은 혈우병 환자에게 상당한 기여를 할 수 있습니다. 항-vWF VHH는 실험실 내에서 설계된 회사입니다. 이러한 단백질은 vWF와 연결되어 신체가 제대로 반응하지 않는 것을 피하면서 문제를 일으키지 않도록 할 수 있습니다. 반면 VHH는 기존 항체보다 작고 제조하기 쉽습니다. 따라서 3가 VHH 생산 치료에 더 나은 선택이 될 수도 있습니다.
Yaohai's scientists are using a variety of approaches to generate anti-vWF VHHs that specifically block the function of 3종 특정 VHH 생산 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.
과학자들은 소위 파지 디스플레이 라이브러리라는 또 다른 방법을 사용했습니다. 따라서 그들은 박테리오파지라고 불리는 작은 바이러스에 연결된 VHH 라이브러리를 가지고 있습니다. 이런 식으로 과학자들은 vWF의 특정 영역에 결합하는 VHH를 선택할 수 있습니다. 이것들을 분리하고 특성화한 후 항-HER2 VHH 생산, 그런 다음 약물의 안전성과 효능을 평가합니다. Yaohai 팀은 또한 다른 연구 그룹 및 회사와 협력하여 추가 VHH를 식별하고 혈우병 동물 모델에서 활동을 평가하고 있습니다. 이 협력은 연구의 심도를 높이는 데 필수적입니다.
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-Pharma는 14년 동안 미생물 CRDMO 솔루션에 주력해 왔습니다. 우리는 전 세계 고객에게 원스톱 생물학적 제제 서비스를 제공합니다.
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