การผลิตแอนติเจน Trypanosoma ตามมาตรฐาน GMP ประเทศไทย

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  GMP Requirements for Consistent Trypanosoma Antigen Batches

  If we are creating Trypanosoma Antigen, we would like each batch that we produce to be identical. That is consistency, a fundamental need of manufacturing. We do have some rules to help enforce consistency in our batches. E.g. We always use the same tools and equipment every time we brew a new batch. And we accurately weigh everything so we know every batch will have the same amount of each ingredient.

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  Adhering to GMP Regulations during Trypanosoma Antigen Manufacturing

  Many reasons why we have to obey GMP Second, it makes sure that the things we make are safe and good. Because health and safety of our customers are our top priority. Also, complying with GMP allows us to save time and money in the long run. When we do not comply with GMP, either we have to redo it all over again or we may have to discard some of the non-compliant batches. Jama solutions can be costly and, we'd rather spend our time helping you – our customers.

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  Scaling Up Trypanosoma Antigen Production while Maintaining GMP Compliance.

  There are cases in which more Trypanosoma Antigen must be produced. If so, we still need to comply with GMP. This is not an easy task but we have some unique techniques and methods to figure out the things. E.g. we can produce an initial quantity of Trypanosoma Antigen and then iteratively increase the amount produced. We wanted to make sure that we did it really carefully, simply so that we ensured everything was still compliant and also the a consistent quality in our batches.

Why choose Yaohai GMP Trypanosoma Antigen Manufacturing?

• ห่วงโซ่อุปทานที่แข็งแกร่งและความสามารถในการผลิต

  Yaohai Bio-Pharma, a top 10 producer of biological products, is a specialist in microbial fermentation. We have built an advanced facility that is equipped with advanced facilities as well as robust RD and manufacturing capabilities. Five drug substance production lines that are compliant with GMP standards for microbial purification and fermentation along with two automated fill and finishing lines for vials, cartridges and needles pre-filled are available. The scales for fermentation available are 100L, 500L, 1000L and 2000L. The filling volume ranges from 1ml to GMP Trypanosoma Antigen Manufacturing. Syringes or cartridges pre-filled are filled with the equivalent of 1-3ml. Our cGMP-compliant production workshop ensures steady supply of clinical samples and commercial products. The bulk molecules produced in our factory can be shipped worldwide.

• ความเชี่ยวชาญระดับมืออาชีพและประสบการณ์อันยาวนาน

  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 GMP Trypanosoma Antigen Manufacturing. 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.

• การปรับแต่ง ประสิทธิภาพ และความคุ้มต้นทุน

  Yaohai Bio-Pharma is experienced in biologicals derived from microbial sources. We provide customized RD solutions and manufacturing, while minimising potential risks. We have worked on various modalities, including recombinant subunit vaccines, peptides hormones, cytokines growth factors, single-domain antibodies enzymes, plasmid DNA various mRNAs, and more. We have specialized in multiple microorganisms, including GMP Trypanosoma Antigen Manufacturing intracellular and extracellular secretion (yields up to 15g/L) and intracellular soluble bacteria and inclusion body (yields up to 10g/L). We have also established a BSL-2 fermentation platform to create bacteria-based vaccines. We are experts in improving processes, boosting product yields, and decreasing production costs. We have a highly efficient technology team that ensures timely and top-quality project delivery. This allows us to bring your unique products faster to market.

• ระบบคุณภาพและการปฏิบัติตามกฎระเบียบระดับโลก

  Yaohai BioPharma is a Top 10 Microbial CDMO that integrates quality management and regulatory affairs. We have a quality management system that is in compliance with current GMP Trypanosoma Antigen Manufacturing and regulations around the globe. Our regulatory team is knowledgeable in the global regulatory frameworks that help accelerate biological launches. We ensure traceable production procedures quality products, as well as in compliance with the guidelines of the US FDA and EU EMA. Australia TGA and China NMPA are also in compliance. Yaohai BioPharma has successfully passed the on-site audit by the European Union's qualified Person (QP) for our GMP quality system and production site. We also successfully cleared the first certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.

หมวดหมู่ผลิตภัณฑ์ที่เกี่ยวข้อง

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• การผลิต GMP Anti-CD8 VHH
• การผลิต GMP Anti-EGFR VHH
• การผลิต GMP Anti-HER3 VHH
• GMP ต่อต้าน MMRCD206 VHH
• GMP แอนตี้-PD-1PD-L1 VHH
• การผลิตแอนติเจน CMV GMP
• การผลิตชิ้นส่วน Fab ตามมาตรฐาน GMP

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