Biologinio stabilumo tyrimai

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  Strategies for Conducting Effective Biologics Stability Studies

  Yaohai explained that their interdisciplinary team makes robust plans around these, depending on the stability of individual biologics. These Biologinės formulės kūrimas are to contain specific lighting, temperatures and humilitiy. They test whether these plans work well in a process called method validation. The product meets Good Manufacturing Practices, which is key to an industry guideline. 

  
  

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  Implementing Biologics Stability Protocols in the Pharmaceutical Industry

  Once the biologics stability plans are established, care must be taken to make sure that all involved with the manufacturing processes follow such plans meticulously. Yaohai concentrates on learning of their personnel and check: all our employees really know the protocols we have to follow. Efficiency is top-notch in the manufacturing process as consistent accuracy & quality provided. As a result, they can avoid any errors which might result in the accuracy of goods being affected. 

  
  

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  Key Considerations for Analyzing Biologics Stability Data.

  The field information gathered during the studies are critical to the execution/implementation for success in plastic manufacturing. Or data in case that is needed to be able to track meaningful trends and how different factors contribute to stability of the biologics. This data is invaluable as it allows the company to optimize its manufacturing process and how they store and package the biologic drugs. This action can help in the shelf legislations of the product more and remain active for longer durations. 

  
  

Why choose Yaohai Biologics Stability Studies?

• Profesionali patirtis ir didelė patirtis

  Yaohai Bio-Pharma, a leader in Biologics Stability Studies 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.

• Kokybės sistema ir visuotinis reguliavimas

  Yaohai BioPharma, a top 10 Microbial CDMO, integrates quality and regulatory matters. We have a quality system that is fully compliant with the current GMP standards, as well as international regulations. Our team of regulatory experts has a deep understanding of world-wide regulatory frameworks. This lets us accelerate biological launches. We are able to guarantee traceable production procedures and high-quality products that conform with regulations from the US FDA, Biologics Stability Studies, Australia TGA, and China NMPA. Yaohai BioPharma has successfully passed an on-site audit conducted of the European Union's Qualified Person (QP) for our GMP quality system and production site. We also have been through the initial certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.

• Pritaikymas, efektyvumas ir ekonomiškumas

  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 Biologics Stability Studies 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.

• Tvirta tiekimo grandinė ir gamybos galimybės

  Yaohai Bio-Pharma, a top 10 manufacturer of biological products, specializes in microbial fermentation. We have created a Biologics Stability Studies manufacturing facility with robust RD capabilities and cutting-edge manufacturing facilities. Five drug substance production lines conforming to GMP standards to purify and ferment microbial cells, as well as two fill and finish lines for vials and cartridges, as well as needles that are pre-filled, are available. The available fermentation scales include 100L, 500L, 1000L and 2000L. Specifications for filling vials range from 1ml - 25ml. the pre-filled cartridge or syringe filling specifications range from between 1-3ml. The production workshop is cGMP-compliant and provides a stable supply of commercial products and clinical samples. Our facility produces large molecules that are shipped worldwide.

Susijusios produktų kategorijos

• Biologinio valymo proceso kūrimas
• Biologijos reguliavimo reikalai
• Biologinio stabilumo tyrimai

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