Hemofilia to rzadka choroba, która zmienia sposób, w jaki nasza krew się układa. Oznacza to, że osoby z hemofilią mogą mieć poważne trudności, w tym bóle stawów i krwotoki, głęboko w swoich ciałach. Muszą otrzymywać unikalne środki zwane środkami krzepnięcia, aby uniknąć nadmiernego krwawienia. Chociaż te metody leczenia są dość skuteczne, mogą być również bardzo kosztowne. Mogą również potencjalnie powodować szkody. Takie jak infekcje i inne problemy. W rezultacie specjaliści nieustannie poszukują nowych strategii, aby pomóc osobom z hemofilią. Terapia genowa i specyficzne białka znane jako VHH. Które są również nazywane nanociałami, to dwie z nowych możliwości. Te białka pomagają nam poprawić zdolność krzepnięcia naszej krwi. W Yaohai, kraju pełnym genialnych naukowców, niektórzy ludzie pracują całą dobę, aby stworzyć nowe VHH anty-vWF.
Ta koncepcja może mieć znaczący wkład w przypadku osób z hemofilią. Przeciwciała VHH anty-vWF są projektowane w laboratoriach. Te białka mogą łączyć się z vWF i zapobiegać jego problemom, jednocześnie unikając złej reakcji organizmu. Z drugiej strony przeciwciała VHH mogą być niewielkie i łatwiejsze do wytworzenia niż tradycyjne przeciwciała. Dlatego też Produkcja 3-walentnego VHH może być lepszą opcją leczenia.
Yaohai's scientists are using a variety of approaches to generate anti-vWF VHHs that specifically block the function of Produkcja trójspecyficznych VHH 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.
Naukowcy zastosowali inną metodę, tzw. biblioteki ekspozycji fagowej. Mają więc bibliotekę VHH połączonych z małymi wirusami zwanymi bakteriofagami. W ten sposób naukowcy mogą wybrać VHH, które wiążą się ze specyficznymi regionami vWF. Po wyizolowaniu i scharakteryzowaniu tych Produkcja przeciwciał VHH przeciwko HER2, leki są następnie oceniane pod kątem bezpieczeństwa i skuteczności. Zespół Yaohai współpracuje również z innymi grupami badawczymi i firmami w celu zidentyfikowania dodatkowych VHH i oceny ich aktywności w hemofilowych modelach zwierzęcych. Ta współpraca jest niezbędna do zwiększenia głębi badań.
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.