Pembuatan Mikroba untuk Pasokan Klinis Indonesia

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  Boosting Efficiency and Quality in Clinical Supply with Microbial Manufacturing

  What is so wonderful about microbial manufacturing is that it helps us to maintain the quality of our medicine. We control carefully (sic) how the medicine is made, so that every batch is the same. This means our medicine acts the same way for patients every time they buy it allowing them access to reliable, consistent doses of medicine. 

  
  

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  Microbial Manufacturing for Clinical Success

  In Yaohai, we make our medication this way, and is allows us to create a lot of quantities in a much smaller time. This Pengembangan Proses Fermentasi Mikroba is very significant to ensure that we can supply our drug to meet its fine demand. In this way, the patients may access the medication they need when they do not have it available turns to be vital for their health and overall being. 

  
  

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  Microbial Manufacturing Delivers Results

  The advantages inherent to microbial manufacturing are clear: it is faster, cheaper, and yields higher-grade medicine. However, it is crucial to keep in mind that all these advantages are not something mythical or hypothetical — they are practical outcomes that we have witnessed. 

  
  

Why choose Yaohai Microbial Manufacturing for Clinical Supply?

• Keahlian Profesional & Pengalaman Luas

  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 Microbial Manufacturing for Clinical Supply CDMO services.

• Sistem Mutu & Kepatuhan Terhadap Peraturan Global

  Microbial Manufacturing for Clinical Supply is a Top 10 Microbial CDMO that incorporates quality control and regulatory matters. We have established a robust quality system that complies with the current GMP standards and regulations all over the world. Our regulatory team is well-versed on global regulatory frameworks to speed up biological launches. We guarantee traceable production processes and top-quality products that are compliant with the rules of US FDA, EU EMA, Australia TGA, and China NMPA. Yaohai BioPharma successfully passed an audit on site conducted by an accredited Qualified Person from the European Union (QP) to review our GMP system and production facility. Additionally, we've passed the first certification audits of the ISO9001 Quality Management System, ISO14001 Environmental Management System, and ISO45001 Occupational Health and Safety Management System.

• Rantai Pasokan & Kemampuan Manufaktur yang Kuat

  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 Microbial Manufacturing for Clinical Supply. 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.

• Kustomisasi, Efisiensi & Efektivitas Biaya

  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 Microbial Manufacturing for Clinical Supply 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.

Kategori produk terkait

• Pengembangan dan Pembuatan Biosimilar Mikroba
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