عملية التخمير والتنقية VLP

• كيف يُحدث تخمير VLP ثورة في صناعة الأدوية الحيوية

  وقد تم اقتراح VLPs للمساعدة في علاج مجموعة واسعة من الأمراض، بدءا من السرطان إلى الأنفلونزا. ومن خلال تقليد الفيروسات، فإنها تساعد أجسامنا على التعرف عليها وتمنعنا من الإصابة بالمرض. وهذا أمر مثير للغاية لأنه يمنحنا الأدوات اللازمة لتحسين أنفسنا في جميع هذه الأمراض التي تصيب أجزاء كبيرة من البشرية.

• دليل مبسط لعملية التخمير والتنقية

  لكن إنشاء VLPs ليس بالأمر السهل. ولهذا علينا أن نصنعها بطريقة تأخذ شكل "ينبغي" وعندها فقط يمكن استخدامها كدواء. وهذا هو بالضبط المكان الذي يحدث فيه فن التخمير. في الوقت الحاضر، تنتج شركات الأدوية الحيوية VLPs على نطاق غير مسبوق من خلال التخمير، وتهدف إلى إنتاج العلاجات بأسعار معقولة.

• رحلة إنتاج VLP”.

  القرار الأول الذي يتعين على العلماء اتخاذه يتعلق بالكائنات الحية الدقيقة التي يريدون تخميرها. وعليهم أيضًا تحديد العناصر الغذائية التي ستساعد تلك الكائنات الحية الدقيقة على الازدهار وإنتاج VLP المثالي. تمامًا مثل اختيار المكونات المناسبة للوصفة.

لماذا تختار عملية التخمير والتنقية Yaohai VLP؟

• الخبرة المهنية والخبرة الواسعة

  Yaohai Bio-Pharma, a leader in CDMOs of microbial biologics, is headquartered in Jiangsu. We have been focused on microbially produced therapeutics and vaccines that are suited for human, veterinary and the management of VLP Fermentation and Purification Process. We have the most the most advanced RD as well as manufacturing technology platforms, which cover the entire process from Microbial strain engineering, cell banking as well as process and method development to commercial and clinical manufacturing, assuring the successful supply of the most cutting-edge solutions. We have accumulated a huge amount of experience in the bio processing of microbial cells. We have delivered over 200 projects across the globe and have assisted our clients with navigating the rules and regulations of the US FDA, EU EMA, Australia TGA, and China NMPA. Our expert knowledge and vast experience enable us to swiftly adapt to market needs and offer tailored CDMO services.

• نظام الجودة والامتثال التنظيمي العالمي

  Yaohai BioPharma is a Top 10 Microbial CDMO that incorporates quality control and regulatory matters. We have a quality system which is in line with current GMP standards and international regulations. Our regulatory team is knowledgeable in global regulatory frameworks to accelerate biological launches. We ensure traceable manufacturing processes and top-quality products that are compliant with the requirements of the US FDA, EU EMA, Australia TGA, and VLP Fermentation and Purification Process. Yaohai BioPharma has successfully passed the audit on site of the European Union's qualified Person (QP) for our GMP quality system and production site. In addition, we've cleared the first certification audits of the ISO9001 Quality Management System, ISO14001 Environmental Management System, and ISO45001 Occupational Health and Safety Management System.

• سلسلة توريد قوية وقدرات تصنيعية

  Yaohai Bio-Pharma, a top 10 producer of VLP Fermentation and Purification Process, specializes in microbial fermentation. We have set up a modern facility with advanced facilities as well as robust RD manufacturing capabilities. Five production lines for drug substances complying with GMP standards for microbial purification and ferment along with two automated fill and finish lines for vials as well as cartridges as well as pre-filled needles are readily available. The available fermentation scales range between 100L and 2000L. Vial filling specifications cover 1ml - 25ml. the pre-filled cartridge or syringe filling specifications are between 1-3ml. The production workshop is cGMP certified and offers the availability of commercial and clinical samples. Our plant produces big molecules that are exported to all over the world.

• التخصيص والكفاءة وفعالية التكلفة

  Yaohai Bio-Pharma is experienced in the development of microbial-derived biologics We offer tailored RD solutions and manufacturing while keeping risks to a minimum We have used a variety of modalities including recombinant subunits vaccines (including peptides) growth factors hormones and Cytokines We've specialized in several microorganisms like yeast intracellular and extracellular secretion (yields up to 15g/L) and bacteria intracellular soluble and inclusion body (yields as high as 10g/L) We have also created a VLP Fermentation and Purification Process fermentation system to develop bacteria-based vaccines We are experts in optimizing processes increasing yields as well as reducing production costs Utilizing a strong technology team we ensure timely and quality project delivery to bring your exclusive products to market faster

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