Mikrobielle Masterzellbank Deutschland

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  Quality Assurance for Biologics

  Biologics are so distinctly altered or fragile that we must choose our comparisons wisely to make them as good as possible. During the building, things can also go wrong that can affect drug efficacy or how safe they are for patients. Quality assurance checks confirm, for patient safety and efficacy, that biologics are what they say they are. Yaohai Microbial MCB is confirmed their natural quality received very carefully These validations will prevent the runtime issues.

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  The Importance of a Reliable Master Cell Bank

  A master cell bank is very crucial in the world of Rekombinante Insulinmutations-Bioproduktion. It is a library containing cells; the same cells that we historically would reuse in developing biologics. Either one adapted into FR360 from their master cell banks, the best of which would be banked clean and viable cells. Therefore, Inadequately maintained, this could affect the integrity of cells and ultimately lead to safe and effective drug products. The fortress of the cells is Yaohai´s bank where we keep its purity and potency so we will be able to keep producing this great biologics that benefits so much our patients. These medications are relied upon by them because they help in reducing their symptoms.

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  Ensuring Consistency in Biopharmaceutical Production

  Bioproduktion von rekombinantem Schweineinsulin = Good Quality Biologics All biologics must be consistent so they can do an effective and dependable job of treating diseases. If each batch of the medication is a different composition, it could make it difficult for doctors and patients to know whether the medication will work at all. Yaohai knows this very well, and has made great efforts to create smock bank of good quality. It's critically important to have that bank in order to ensure the safety and efficacy of each batch of biologics made. Preserved cells can then be used to create the same cells for patients, a supply of biologics that never runs out.

Why choose Yaohai Microbial Master Cell Bank?

• 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 Microbial Master Cell Bank 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.

• Robuste Lieferkette und Fertigungskapazitäten

  Yaohai Bio-Pharma, a top 10 producer of biological products, is a specialist in microbial fermentation. We have established an advanced facility that is equipped with modern facilities and strong RD manufacturing capabilities. We have five drug substance manufacturing lines that are in compliance with GMP requirements for microbial fermentation and purification, as well as two fill-finish lines that are automated for cartridges, vials, as well as pre-filled syringes. The available fermentation scales vary from 100L to 500L, 1000L and 2000L. Microbial Master Cell Bank for vias are 1ml to 25ml, whereas the pre-filled syringes and cartridge filling specifications cover 1-3ml. Our production workshop is cGMP compliant and guarantees steady supply of clinical samples as well as commercial items. Our plant produces large molecules which are shipped to the globe.

• Fachkompetenz und langjährige Erfahrung

  Microbial Master Cell Bank 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.

• Anpassung, Effizienz und Kosteneffizienz

  Yaohai Bio-Pharma has experience in the manufacture of biologics derived from microorganisms. We offer tailored RD solutions and manufacturing while minimizing the risk. We have worked with diverse methods, such as Microbial Master Cell Bank of vaccines (including peptides), growth factors, hormones, and Cytokines. We specialized in multiple microbial hosts, including yeast extracellular and intracellular (yield up to 15 g/L) bacteria periplasmic secretion, soluble intracellular, and inclusion bodies (yield up to 10 grams/L). We also have a BSL-2 fermentation platform to create bacterial vaccines. We specialize in improving processes, increasing product yields, as well as reducing production costs. We have an efficient technology team that guarantees timely and quality project delivery. This allows us to deliver your exclusive products quicker to market.

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