إنتاج الأنسولين السلائف كهيئة شاملة

• هيئات الشمول كتقنية واعدة لإنتاج الأنسولين الدقيق

  وقد تم إدراج الهيئات لتخليق الأنسولين البشري منذ سنوات عديدة حتى الآن. من خلال دراسة رائعة جدًا، استخدموا الإشريكية القولونية، وهي بكتيريا E. ومن الواضح أن هذه البكتيريا كانت ناجحة في إنتاج البرونسولين محليًا في الأجسام المتضمنة. ثم قاموا بتجميع الأجسام المتضمنة، واستخرجوها وأعادوا تشكيلها إلى أنسولين نشط.

• إنتاج الأنسولين السلائف في الهيئات المشمولة

  تمت إزالة هذه الأجسام المتضمنة ثم قام العلماء بإعادة طيها لإنتاج الأنسولين النشط. ومما أثار دهشتهم كثيرًا، عندما قاموا بفحص بروتين الأنسولين الجسمي المنقى المتكون في البكتيريا المحفزة بالإجهاد، أظهر أنه ذو جودة عالية مقارنة بجميع العمليات التي تمت تجربتها سابقًا.

• احتضان هيئات الإدماج لتعزيز الغلات

  وبينما يواصل العلماء النظر في هذا النهج الجديد، فمن المرجح أن يتحسنوا ويحسنوا إنتاج الأنسولين. إذا كان الأمر كذلك، فقد يترجم ذلك إلى المزيد من الأنسولين للأشخاص الذين يحتاجون إليه وانخفاض التكاليف مما يعني سهولة الوصول لأولئك الذين يحاولون الحصول على الدواء الذي يحتاجونه.

لماذا تختار شركة Yaohai Precursor Insulin Production كهيئة شاملة؟

• الخبرة المهنية والخبرة الواسعة

  Yaohai Bio-Pharma is a leading in microbial biologics CDMO. Our main focus has been the production of microbial vaccinations and therapeutics to manage the health of pets, humans and animals. health. We have modern RD and manufacturing technology platforms that cover the entire process, from microbial strain engineering, cell banking, process and method design to commercial and clinical manufacturing, which ensures the success supply of the most cutting-edge solutions. Through the years we have gained vast expertise in using microbial sources. Over 200 projects were successfully completed. In addition, we support our clients in get through regulations, such as those of the US FDA as well as EU EMA. We also help them to navigate Australia TGA and China NMPA. Our expert knowledge and vast experience allow us to quickly respond to market demands and provide Precursor Insulin Production as Inclusion Body CDMO services.

• التخصيص والكفاءة وفعالية التكلفة

  Yaohai Bio-Pharma has experience in the manufacture of biologics derived from microorganisms. We offer tailored RD solutions and manufacturing while minimizing the risk. We have worked with diverse methods, such as Precursor Insulin Production as Inclusion Body of vaccines (including peptides), growth factors, hormones, and Cytokines. We specialized in multiple microbial hosts, including yeast extracellular and intracellular (yield up to 15 g/L) bacteria periplasmic secretion, soluble intracellular, and inclusion bodies (yield up to 10 grams/L). We also have a BSL-2 fermentation platform to create bacterial vaccines. We specialize in improving processes, increasing product yields, as well as reducing production costs. We have an efficient technology team that guarantees timely and quality project delivery. This allows us to deliver your exclusive products quicker to market.

• سلسلة توريد قوية وقدرات تصنيعية

  Yaohai Bio-Pharma, a top 10 manufacturer of biological products, is a specialist in microbial fermentation. We have established an efficient factory that has advanced facilities and robust RD and manufacturing capabilities. Five production lines for drug substances conforming to GMP standards for microbial fermentation and purification along with two fill and final lines for vials and cartridges and pre-filled needles are on offer. The available fermentation scales vary between 100L and Precursor Insulin Production as Inclusion Body. Filling specifications for vias are 1ml up to 25ml. the pre-filled cartridge or syringe filling specifications are 1-3ml. The workshop for production is cGMP-compliant and provides that there is a steady supply of commercial and clinical samples. Our facility produces large molecules that are shipped worldwide.

• نظام الجودة والامتثال التنظيمي العالمي

  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. Precursor Insulin Production as Inclusion Body 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.

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