Výroba rekombinantních peptidů GMP Česká republika

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  Ensuring safety and consistency in peptide manufacturing

  Safety is paramount in our peptide-making efforts. Our products are clean and compliant. Key bacteria and viruses that may have the potential to render the product unfit for human use, Yaohai Výroba semaglutidu GMP  are our main focus. We experiment in clean rooms where all things are sterile from any contamination. We also test our approaches to make sure they are safe and efficient. And in order to further do our due diligence, we test each batch of our products to ensure they pass our rigorous qualifications and are suitable for usage.

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  Applying GMP guidelines to recombinant peptide synthesis

  Reciprocal peptide synthesis: One of the specific ways in which we create peptides is called reciprocal peptide synthesis. We thus rely upon recombinant protein expression for these valuable proteins. There some a specialized equipment and knowledge to overcome with the type of cleaning also you need to maintain the safety too. We have gained a lot of experience in this field at Yaohai In doing so, We comply with the best practice ensuring all our merchandise will be high quality and completely safe for anyone use.

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  Meeting demand for therapeutic peptides with GMP manufacturing processes

  And with the growing number of use cases, more and more people are in need of therapeutic peptides. If we hope to meet the demand for them, we need to be able to produce thousands of tons of peptides without any decrease in quality/never compromising safety. And this is where GMP manufacturing steps in. Yaohai Výroba GMP Anti-CD8 VHH  is the acronym for Good Manufacturing Practices, and this makes our procedure to manufacture peptides standard. We can synthesize lots of peptides at Yaohai but we always keep them safe and high quality. Patients will then receive top care in their individual health matters.

Why choose Yaohai GMP Recombinant Peptide Manufacturing?

• Robustní dodavatelský řetězec a výrobní kapacity

  Yaohai Bio-Pharma, a top 10 manufacturer of biological products, specializes in microbial fermentation. We have created a GMP Recombinant Peptide Manufacturing manufacturing facility with robust RD capabilities and cutting-edge manufacturing facilities. Five drug substance production lines conforming to GMP standards to purify and ferment microbial cells, as well as two fill and finish lines for vials and cartridges, as well as needles that are pre-filled, are available. The available fermentation scales include 100L, 500L, 1000L and 2000L. Specifications for filling vials range from 1ml - 25ml. the pre-filled cartridge or syringe filling specifications range from between 1-3ml. The production workshop is cGMP-compliant and provides a stable supply of commercial products and clinical samples. Our facility produces large molecules that are shipped worldwide.

• Profesionální odbornost a rozsáhlé zkušenosti

  Yaohai Bio-Pharma, a leader in CDMOs for microbial biologics, is located in Jiangsu. We are focusing on microbially produced therapeutics and vaccines that are GMP Recombinant Peptide Manufacturing for human, veterinary as well as pet health management. We have the most cutting-edge RD platforms as well as manufacturing technology that cover the entire manufacturing process, from microbial strain development, cell banking, process and method development to clinical and commercial manufacture which ensures successful production of novel solutions. We have gained an extensive amount of experience in bio processing of microbial cells. More than 200 projects have been successfully completed, and we support our clients in get through regulations, such as those of US FDA as well as EU EMA. We also aid them with Australia TGA and China NMPA. Our experience and professional knowledge as well as our extensive knowledge allow us to quickly respond to market demands and provide customized CDMO services.

• Systém kvality a dodržování globálních předpisů

  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. GMP Recombinant Peptide Manufacturing 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.

• Přizpůsobení, efektivita a hospodárnost

  Yaohai Bio-Pharma has experience in manufacturing biologics that are created from microorganisms. We offer bespoke RD solutions as well as manufacturing services while minimising potential risks. We have worked with diverse techniques, such as recombinant cellular subunits, vaccines (including peptides), growth factors, hormones, and the GMP Recombinant Peptide Manufacturing. We are a specialist in many microorganisms like yeast extracellular and intracellular secretion (yields up to 15g/L) and bacteria intracellular soluble, and inclusion body (yields up to 10g/L). We have also developed a BSL-2 fermentation platform to create bacterial vaccines. We have a track record of improving production processes, thereby increasing yields and reducing costs. We have a highly-efficient technology team to ensure timely and high-quality delivery of projects. This helps us bring your products that are unique faster to the market.

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