Pengembangan Formulasi Biologi Indonesia

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  Optimizing Biologics for Safe and Effective Clinical Use

  Formula development is an extremely critical aspect of biologics manufacturing. If biologics do not contain the correct combination of ingredients, in the right proportions, or are not formulated properly, they may not function well (or could even be toxic to) patients. Yaohai recognizes that formulation development is a key part of biologics manufacture. They do the hard work to design stable, efficient mixtures compliant at industry-leading safety and quality standards.

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  The Crucial Role of Formulation Development in Biologics Manufacturing

  Background: Formulation development is a critical step in the manufacturing of biologics and small molecules. It helps scientists learn how to mix and match various components into the perfect balance that will cause a finished product to be both safe and effective. Through its work in formulation development, Yaohai works to make sure the medicines patients are given will do what they should do.

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  Meningkatkan Hasil Pasien

  Personally, I think the ultimate goal for biologics Insulin 1 is making patients feel better and improving their general health at the end of the day. As a company, Yaohai Hormon Pertumbuhan 1 is committed to improving the life of patients by delivering medicines that are known to be safe and effective in fighting against various sicknesses. They know that everyone is different and so each disease has to be dealt with differently. This is one of the main reasons that so much time and effort worked into forging custom medicines that can answer to any patients personal medical requirements.

Why choose Yaohai Biologics Formulation Development?

• 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 Biologics Formulation Development 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.

• Rantai Pasokan & Kemampuan Manufaktur yang Kuat

  Yaohai Bio-Pharma, a top 10 manufacturer of biological products, is a specialist in microbial fermentation. We have established an efficient factory that has advanced facilities and robust RD and manufacturing capabilities. Five production lines for drug substances conforming to GMP standards for microbial fermentation and purification along with two fill and final lines for vials and cartridges and pre-filled needles are on offer. The available fermentation scales vary between 100L and Biologics Formulation Development. Filling specifications for vias are 1ml up to 25ml. the pre-filled cartridge or syringe filling specifications are 1-3ml. The workshop for production is cGMP-compliant and provides that there is a steady supply of commercial and clinical samples. Our facility produces large molecules that are shipped worldwide.

• 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 Biologics Formulation Development. 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.

• Kustomisasi, Efisiensi & Efektivitas Biaya

  Yaohai Bio-Pharma is Biologics Formulation Development in microbial-derived biologics. We offer custom RD as well as manufacturing solutions, while minimising the risk. We've been involved in numerous modalities like recombinant subunit vaccines, peptides hormones, cytokines growth factors, single-domain antibodies, enzymes, plasmid DNA, the mRNA, and other. We are experts in several Microbial hosts, such as yeast extracellular and intracellular (yield up to 15 grams per liter) bacteria periplasmic secretion as well as soluble intracellular inclusion bodies (yield up to 10 grams/L). Additionally, we have developed the BSL-2 microbial fermentation platform for the development of bacterial vaccines. We have a track record of improving production processes, thereby increasing yields, and reducing costs. With a highly efficient technology team, we guarantee prompt and reliable project delivery and bring your products to market quicker.

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