Large-molecule Lot Release Testing Indonesia

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  Streamlining the large-molecule lot release testing process for improved efficiency

  Testing can be a slow and grueling process for scientists. This is why Yaohai applies modern technologies and approaches to accelerate the tests and automation. They have made the use of some new machines and tools where you can get all the functioning tested as per your requirement. Taking automation as an example — this is when a part of the work that was previously done by people can now be done by machines. This helps in faster re-doing and be more effective. Yaohai also provides regular Produksi Plasmid Telanjang inspection and updating of their trial technique to be sure that the techniques are doing sufficiently well. Microbiotica claim to be working on speeding up this process, in order that they can bring their drugs to market faster whilst maintaining the standard of quality and safety.

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  A critical step in drug development

  Lot release testing is a very critical step in the manufacturing of drugs, the process is also crucial for large molecule. By ensuring safety and efficacy inspections of all products, this ensures that each product will be of a good standard. Yaohai is in this business; they know what medicine means to human life and so take this process very seriously. Their charge is to see to it that the medicines they produce are strong enough and insofar, effectual. This step is another way the company has been able to share in its mission to offer reliable products customers can use. It is a step to give confidence to the customers that they are buying tested medicines and hence safe for their own consumption also.

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  Advancements in large-molecule lot release testing techniques.

  For some time now, large-molecule lot release testing has been the norm. However product technology is continually evolving and improving. We need to grasp new testing and quality assurance methodologies, as Yaohai does. New techniques such as mass spectrometry and fluorescence have evolved over the years. The benefits of these newer techniques are that they can produce scrupulous information sooner rather than later. Yaohai essentially have the highest standard of medicines at their disposal, by consistently investing in new technology and employee knowledge enhancement. They are committed to the latest advances in testing for their own safety and use.

Why choose Yaohai Large-molecule Lot Release Testing?

• Keahlian Profesional & Pengalaman Luas

  Yaohai Bio-Pharma is a leading microbial biologics CDMO. Our main focus has been the production of Large-molecule Lot Release Testing and therapeutics to treat pets, human and veterinary health. We have state-of-the-art RD platforms and manufacturing technology that cover the entire manufacturing process beginning with the development of microbial strains Cell banking, process and method development, through commercial and clinical manufacture that ensures the successful delivery of innovative solutions. Over time we've gained a vast knowledge of microbial-based bio processing. We have successfully completed more than 200 global projects, and help our clients with navigating the rules and regulations of the US FDA, EU EMA, Australia TGA, and China NMPA. We are able to react promptly to market demands and provide tailored CDMO services due to our experience and expertise.

• Kustomisasi, Efisiensi & Efektivitas Biaya

  Large-molecule Lot Release Testing has experience in manufacturing biologics that are that are derived from microorganisms. We provide tailored RD as well as manufacturing solutions, while minimising the risk. We have experimented with a variety of techniques, such as recombinant cellular subunits of vaccines (including peptides), growth factors, hormones and the cytokines. We have specialized in multiple microorganisms like yeast extracellular and intracellular secretion (yields up to 15g/L) and bacteria intracellular soluble and inclusion bodies (yields up to 10g/L). We also have the BSL-2 fermentation platform to develop bacterial vaccines. We are experts in improving processes, increasing product yields, and decreasing production costs. With an effective technology team, we ensure timely and quality project delivery and bring your products to market faster.

• 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-molecule Lot Release Testing 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.

• Sistem Mutu & Kepatuhan Terhadap Peraturan Global

  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 Large-molecule Lot Release Testing 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.

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