Zulassungsfragen für Biologika Deutschland

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  Herausforderungen und Möglichkeiten

  The road from the laboratory bench to the marketplace where biologic medicines are sold to consumers is a complex and protracted one. In this way, research starts at a much earlier stage as scientists try to find new biologic medicines and evaluate their methods of treating diseases. Once a biologic medicine has been developed and successfully tested it is subjected to an extensive approval process before sale to consumers. 

  
  

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  Understanding the Journey from Bench to Market

  At Yaohai, their specialist assembly of professionals work hand-in-hand with leading scientists to support medicines research and development. They facilitate in providing the required information and also guide broader regulatory landscape to be sure that all data needed are submitted for approval. After approval of the medicine, they take more actions in order to manufacture and market it according to all regulatory rules. 

  
  

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  Meeting the Complex Needs of Patients and Industry

  At Yaohai, their specialist assembly of professionals work hand-in-hand with leading scientists to support medicines research and development. They facilitate in providing the required information and also guide broader regulatory landscape to be sure that all data needed are submitted for approval. After approval of the medicine, they take more actions in order to manufacture and market it according to all regulatory rules. 

  
  

Why choose Yaohai Biologics Regulatory Affairs?

• Anpassung, Effizienz und Kosteneffizienz

  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 Biologics Regulatory Affairs. 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.

• Robuste Lieferkette und Fertigungskapazitäten

  Yaohai Bio-Pharma, a top 10 producer of Biologics Regulatory Affairs, specializes in microbial fermentation. We have set up a modern facility with advanced facilities as well as robust RD manufacturing capabilities. Five production lines for drug substances complying with GMP standards for microbial purification and ferment along with two automated fill and finish lines for vials as well as cartridges as well as pre-filled needles are readily available. The available fermentation scales range between 100L and 2000L. Vial filling specifications cover 1ml - 25ml. the pre-filled cartridge or syringe filling specifications are between 1-3ml. The production workshop is cGMP certified and offers the availability of commercial and clinical samples. Our plant produces big molecules that are exported to all over the world.

• Qualitätssystem und Einhaltung globaler Vorschriften

  Yaohai BioPharma, a top 10 Microbial CDMO that integrates quality management and regulatory affairs. Our quality system that is compliant with current GMP standards as well as international regulations. Our team of regulatory experts is proficient in global regulatory frameworks to accelerate biological launches. We ensure traceable production procedures quality products, as well as conformity with the requirements of the Biologics Regulatory Affairs and EU EMA. Australia TGA and China NMPA are also met. Yaohai BioPharma successfully passed an in-person audit conducted by a Qualified Person of the European Union (QP) to examine our GMP system and production facility. We also completed the initial certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.

• Fachkompetenz und langjährige Erfahrung

  Yaohai Bio-Pharma, a leader in Biologics Regulatory Affairs of microbial biologics, is located in Jiangsu. We are focusing on microbially produced therapeutics and vaccines that are suited for human, veterinary, and pet health management. We have modern RD as well as manufacturing technology platforms that cover the entire process, from engineering microbial strains, cell banking, process and method development, through to commercial and clinical manufacturing, making sure that we can ensure the successful supply of the most cutting-edge solutions. We have acquired a large amount of experience in the microbial bio processing field. More than 200 projects have been completed successfully and we support our clients in overcome regulations such as those of the US FDA and EU EMA. We also aid them with Australia TGA and China NMPA. We are able to respond rapidly to market requirements and offer customized CDMO services thanks to our experience and expertise.

Verwandte Produktkategorien

• Entwicklung von Biologika-Formulierungen
• Zulassungsfragen für Biologika
• Stabilitätsstudien für Biologika

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