Entwicklung analytischer Methoden für Biologika Deutschland

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  Optimizing Analytical Methods for Effective Biologics Developmen

  We also learn at Yaohai to improve our ways of learning. In this process, we are assisted by the latest tools and technology available today. We are also sure to provide our scientists with the proper training in using these tools properly. That way, when our biologics are analyzed by our scientists they are doing the best with what current technology allows for. Doing all of these things helps us be sure the biologics we make are as effective and safe as they can be.

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  Challenges and Solutions in Biologics Analytical Method Developmen

  Here at Yaohai, we pledge to rise above those challenges. In other words, we work hand in hand with our clients to figure out what exactly they need. We know how to use it in biologics construction by hearing what our clients have to say. We Herstellung des Bakteriophagen AP205 VLP also implement the most advanced technologies and pioneering methods touchstone in order to guarantee safety and efficacy for our biologics.

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  The Role of Analytical Method Developmen

  We all know that studying is important — Herstellung von Bakteriophage Q VLP yet not all of us know how to do this right, or at least to do it better. At Yaohai we take your ways of studying seriously. We recognize that we can make biologics that work only if they are also safe when we make use of state-of-the-art methodologies and modern technology. Our team is passionately focused on lending their expertise to help our clients achieve the greatest biologics for patients everywhere.

Why choose Yaohai Biologics Analytical Method Development?

• Robuste Lieferkette und Fertigungskapazitäten

  Yaohai Bio-Pharma is a Top 10 biological company that specializes in Biologics Analytical Method Development. We have built a modern manufacturing facility with robust RD capabilities and modern manufacturing facilities. Five drug substance production lines complying with GMP standards for microbial fermentation and purification along with two fill and final lines for vials and cartridges as well as pre-filled needles are readily available. The available fermentation scales vary between 100L and 2000L. The filling volume ranges from 1ml up to 25ml. Syringes or cartridges that are pre-filled are filled with 3 to 3.5ml. Our production workshop that is cGMP-compliant ensures constant supply of clinical sample and commercial products. Our facility produces large molecules that are exported to all over the world.

• Qualitätssystem und Einhaltung globaler Vorschriften

  Yaohai BioPharma is a Top 10 Microbial CDMO that incorporates quality control and Biologics Analytical Method Development. We have developed a solid quality system that adheres to current GMP standards and regulatory requirements worldwide. Our regulatory team is knowledgeable on global regulatory frameworks to expedite biological launches. We make sure that production processes are traceable with high-quality products as well as complying with the rules of the US FDA and EU EMA. Australia TGA and China NMPA are also in compliance. Yaohai BioPharma successfully passed an on-site audit conducted by a Qualified Person from the European Union (QP) to examine our GMP process and manufacturing facility. We also successfully been through the initial certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.

• Anpassung, Effizienz und Kosteneffizienz

  Biologics Analytical Method Development 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.

• Fachkompetenz und langjährige Erfahrung

  Biologics Analytical Method Development is a leading in microbial biologics CDMO. Our focus has been on microbial-produced vaccines and therapeutics that are suited for human, veterinary, as well as pet health management. We have the most cutting-edge RD platforms and manufacturing technology which cover the entire procedure beginning with the development of microbial strains and cell banking, to process and method development, to commercial and clinical production which ensures successful delivery of innovative solutions. Over time, we have accumulated vast knowledge of microbial-based bio processing. Over 200 projects have been successfully completed, and we assist our clients to comply with regulations like those of US FDA and EU EMA. We also help them to navigate Australia TGA and China NMPA. Our professional expertise and extensive experience allows us to quickly respond to market demands and provide bespoke CDMO services.

Verwandte Produktkategorien

• Analytische Methoden für Plasmid-DNA
• Herstellung des Bakteriophagen AP205 VLP
• Herstellung von Bakteriophage Q VLP
• Herstellung chimärer VLP-Impfstoffe
• Herstellung konjugierter VLP-Impfstoffe
• Herstellung von DNA-Impfstoffen
• E. coli-Fermentation zur VLP-Produktion
• Herstellung von GLP-1-Agonisten
• GLP-1 Analoge Fertigung

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