Pengisian dan Penyelesaian Molekul Besar Indonesia

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  Precision Manufacturing for High-Quality Large-Molecule Products

  For the health of it- Yaohai iii aims at giving birth to the ultimate API Semaglutida GMP medicine. Any slight aspect of the production is scrutinized to see that the medicine works when it says it will. This is because they have standardized procedures of auditing and different testing approaches to make them all filled with safety measures. This is so that they know the medicine is safe, and also may work for those who are unwell.

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  Streamlined Operations for Faster Time-to-Marke

  The most important point for Yaohai is that when a person falls we must medicate. This is one of the reason that GMP Anti-PD-1PD-L1 VHH medicine are manufacture by company and it should reach to you in very quick time. They get that time is an important part of the cure for some people. That, this ahead of priority recovery should not be let a patient for waiting so important medicine…

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  Scalable Solutions for Large-Scale Production Needs

  More importantly, the Yaohai create not for some but structure the process to allow its medicine to help many at once. For these all, some particular ways are available by which they make a whole lot of medicines at a single point in time. With hundreds of thousands getting sick, or even potentially millions in a pandemic the large scale production of medicine allows them to treat an uncountable number sick as possible and helps a whole bunch of people get the treatments they need so they can be well.

Why choose Yaohai Large-Molecules Fill and Finish?

• Rantai Pasokan & Kemampuan Manufaktur yang Kuat

  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 Large-Molecules Fill and Finish 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.

• Keahlian Profesional & Pengalaman Luas

  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 Large-Molecules Fill and Finish. 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.

• Sistem Mutu & Kepatuhan Terhadap Peraturan Global

  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. Large-Molecules Fill and Finish 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.

• Kustomisasi, Efisiensi & Efektivitas Biaya

  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 Large-Molecules Fill and Finish. 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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