تصنيع لقاح الحمض النووي

• الحلول القائمة على الحمض النووي"

  كيف يصنع العلماء لقاحات الحمض النووي؟ يحددون جينًا من الجرثومة التي يريدون الاستفادة منها؛ أولاً، إنه مجرد طول صغير من الحمض النووي. إنها عملية دقيقة للغاية حيث يتعين عليهم اختيار الجزء الصحيح من الجرثومة، حتى يتمكن الجهاز المناعي من التعرف عليها. في البداية، يقومون بنسخ هذا الحمض النووي وإدخاله في أداة تسمى البلازميد. (البلازميد = شيء يشبه شاحنة البريد): يساعد الحمض النووي على الوصول إلى الخلايا.

• كيف تُحدِث لقاحات الحمض النووي تأثيرًا كبيرًا في الصحة العامة"

  يتم الآن إدخال البلازميد في الخلية. تبدأ الخلية الآن في تكرار الحمض النووي وإنتاج نسخ عديدة منه. وبسرعة، يتم تصنيع اللقاح من هذه النسخ المدربة. والنتيجة هي أن الباحثين قادرون على صنع دفعة كبيرة من اللقاح مرة واحدة، وهذه السعة الكبيرة تعني أنه يمكنهم مساعدة المزيد من الناس.

• عملية تصنيع لقاحات الحمض النووي

  وأخيرًا، يخضع اللقاح لاختبارات صارمة للتأكد من سلامته وفعاليته. افعل: يقوم العلماء بإجراء هذه الاختبارات للتأكد من أن المنتج آمن وفعال. فإذا جاءت النتيجة جيدة في جميع الاختبارات، فيمكنهم صنع كميات كبيرة منها وتوزيعها على الجميع. ونتيجة لذلك، يمكن للناس الحصول على اللقاح والتمتع بصحة جيدة.

لماذا تختار شركة Yaohai DNA لصناعة اللقاحات؟

• الخبرة المهنية والخبرة الواسعة

  Yaohai Bio-Pharma, a leader in DNA Vaccine Manufacturing of microbial biologics, is located in Jiangsu. We are focusing on microbially produced therapeutics and vaccines that are suited for human, veterinary, and pet health management. We have modern RD as well as manufacturing technology platforms that cover the entire process, from engineering microbial strains, cell banking, process and method development, through to commercial and clinical manufacturing, making sure that we can ensure the successful supply of the most cutting-edge solutions. We have acquired a large amount of experience in the microbial bio processing field. More than 200 projects have been completed successfully and we support our clients in overcome regulations such as those of the US FDA and EU EMA. We also aid them with Australia TGA and China NMPA. We are able to respond rapidly to market requirements and offer customized CDMO services thanks to our experience and expertise.

• 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 DNA Vaccine Manufacturing 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.

• نظام الجودة والامتثال التنظيمي العالمي

  Yaohai BioPharma, a top 10 DNA Vaccine Manufacturing, combines regulatory affairs and quality control. We have a quality system that is compliant with current GMP standards and regulations around the globe. Our regulatory team has deep understanding of world-wide regulatory frameworks. This lets us accelerate biological launches. We ensure traceable production procedures with high-quality products as well as compliance with the regulations of the US FDA and EU EMA. Australia TGA and China NMPA is also fulfilled. Yaohai BioPharma successfully passed an in-person audit conducted by an accredited Qualified Person of the European Union (QP) to examine our GMP system and production facility. We have also passed the initial certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.

• سلسلة توريد قوية وقدرات تصنيعية

  Yaohai Bio-Pharma, a top 10 manufacturer of biological products, specializes in microbial fermentation. We have built a modern facility with robust RD capabilities and advanced equipment. We have five drug substance manufacturing lines that conform to GMP requirements for microbial fermentation and purification. We also have two automated fill-finish lines for cartridges, vials and pre-filled syringes. The fermentation scales available for use range from DNA Vaccine Manufacturing to 2000L. The specifications for the filling of a vial range from 1ml up to 25ml. pre-filled syringe or cartridge filling specifications range from approximately 1-3ml. Our cGMP-compliant production facility ensures constant supply of clinical sample as well as commercial items. Our plant produces big molecules which are shipped to the globe.

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