Single Domain Antibody (sdAb) Process Development

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  Novel sdAb selection methods for improved specificity

  Yaohai and his team have created some highly precise methods to screen the sdAbs. Not only are they highly specific, but more importantly they help them ensure the safety of sdAbs by understanding what will and will not be targeted in the body of a person. This GMP Anti-EGFR VHH Production will ensure that the medicine is safe and effective for all those who require it.  

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  Facilitating sdAb expression in diverse host systems

  They are even looking for types of cells that can produce sdAbs better than their original screen. This helps them to develop even more sdAbs that can efficiently function in targeted fields. This will add to the variety of cells they can screen for sdAbs production and improve on their fusion generation to produce more effective sdAbs. 

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  Advancements in sdAb formulation for enhanced stability and shelf-life

  How long do they last for? And then, what can this guy that you worked with make them very stable so they have a ready time of shelf life as well. Most importantly they keep the medicine in such a place where it remains effective for a longer period. And keeping GMP Anti-HER3 VHH Production stored so carefully means that more people can get the drug without fearing it will no longer work.  

Why choose Yaohai Single Domain Antibody (sdAb) Process Development?

• Professional Expertise & Extensive Experience

  Single Domain Antibody (sdAb) Process 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.

• Quality System & Global Regulatory Compliance

  Yaohai BioPharma is a Top 10 Microbial CDMO that incorporates quality management and regulatory issues. We have developed a solid quality management system that conforms to the current GMP standards and regulations globally. Our regulatory team has an in-depth understanding of the world-wide regulatory frameworks. This allows us to accelerate biological launches. We ensure traceable production processes as well as high-quality products and in compliance with the guidelines of the US FDA and EU EMA. Single Domain Antibody (sdAb) Process Development and China NMPA are also satisfied. Yaohai BioPharma successfully passed an on-site audit conducted by an accredited Qualified Person of the European Union (QP) to review our GMP system and production facility. We have also been through the first certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.

• Customization, Efficiency & Cost-Effectiveness

  Yaohai Bio-Pharma is Single Domain Antibody (sdAb) Process 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.

• Robust Supply Chain & Manufacturing Capabilities

  Yaohai Bio-Pharma, a Single Domain Antibody (sdAb) Process Development manufacturer of biological products, is a specialist in microbial fermentations. We have built a modern factory equipped with modern facilities and strong RD and manufacturing capabilities. Five drug substance production lines that are compliant with GMP standards for microbial purification and ferment, as well as two fill and finish lines for vials as well as cartridges, as well as needles that are pre-filled, are readily available. The available fermentation scales vary from 100L to 500L, 1000L, to 2000L. Filling volumes vary from 1ml to 25ml. Syringes or cartridges pre-filled are filled with the equivalent of 1-3ml. Our cGMP-compliant production facility ensures the availability of stable clinical samples and commercial products. The big molecules that are produced at our plant are readily available for international delivery.

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