IFN-Beta is a special kind of protein that our bodies already make to help protect us against viruses. This is a protein that is key to the human immune system, which essentially protects us from getting ill. IFN-Beta is a medication physicians commonly prescribe to decrease symptoms in particular, diseases such as one of the nervous system inflammation autoimmune illnesses: multiple sclerosis. But to make this useful protein into therapy, it has to be produced in a precise and unique way that is referred to as IFN-Beta manufacturing.
During IFN-Beta manufacture, scientists culture cells which can make this protein in a laboratory. To begin with, they extract certain cells that are then placed in an incubated environment to grow. The IFN-Beta protein is harvested from these cells once they have successfully multiplied and grown. The whole process therefore can last for several weeks, and there are special tools and techniques available to do everything meticulously which the more of effort should be put in to ensure no protein that is got out is contaminous or hazardous enough so that peoples could use as a medicine.
During the viremic phase of an infection, our bodies release IFN-Beta, which is a natural response to a virus. This is a way of our immune system to defend against the infection naturally. This process can be reproduced in the laboratory by scientists. They accomplish this by proliferating cells and inducing these cells to respond to an imitation viral agent. This is usually known as a " stimulant ". "
The manufacture of IFN-Beta is challenging in that the desired protein must sufficiently clean and remain free from all other contaminants. Even a trace of dirt or anything else can render the protein unfit for patients making it useless. Therefore it is essential to have a clean environment throughout the manufacturing process.
In order to tackle this issue, Yaohai has placed strict limitations on the quality control of both sourcing and manufacturing. These steps consist of the use of dedicated tools and techniques, in addition to continuous supervision and test on IFN-Beta protein so that it is pure as well as suitable for usage. This level of detail is crucial to ensure that nothing contaminates the medicine intended for patients.
In the IFN-Beta that Yaohai produces, it is always trying to apply the current tools and technology available in order to create the best product they can. This also includes the use of sophisticated approaches, as chromatography and ultrafilteration which are employed to clarify the protein while excluding impurities.
Moreover, a professional group of scientists and engineers at Yaohai is constantly working towards coming up with novel and creative manufacturing methods. They aim to develop better and more widely accessible IFN-Beta for everyone who needs it. They are always on the lookout for ways to make this vital protein easier to produce, which they believe would improve treatments.
Yaohai Bio-Pharma is a leading microbial biologics CDMO. Our main focus has been the production of Interferon-Beta (IFN-Beta) Manufacturing and therapeutics to treat pets, human and veterinary health. We have state-of-the-art RD platforms and manufacturing technology that cover the entire manufacturing process beginning with the development of microbial strains Cell banking, process and method development, through commercial and clinical manufacture that ensures the successful delivery of innovative solutions. Over time we've gained a vast knowledge of microbial-based bio processing. We have successfully completed more than 200 global projects, and help our clients with navigating the rules and regulations of the US FDA, EU EMA, Australia TGA, and China NMPA. We are able to react promptly to market demands and provide tailored CDMO services due to our experience and expertise.
Yaohai BioPharma is a Top 10 Microbial CDMO that integrates quality management and regulatory affairs. We have a quality management system that is in compliance with current Interferon-Beta (IFN-Beta) Manufacturing and regulations around the globe. Our regulatory team is knowledgeable in the global regulatory frameworks that help accelerate biological launches. We ensure traceable production procedures quality products, as well as in compliance with the guidelines of the US FDA and EU EMA. Australia TGA and China NMPA are also in compliance. Yaohai BioPharma has successfully passed the on-site audit by the European Union's qualified Person (QP) for our GMP quality system and production site. We also successfully cleared the first certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.
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. Interferon-Beta (IFN-Beta) Manufacturing 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.
Yaohai Bio-Pharma is experienced in the development of microbial-derived biologics We offer tailored RD solutions and manufacturing while keeping risks to a minimum We have used a variety of modalities including recombinant subunits vaccines (including peptides) growth factors hormones and Cytokines We've specialized in several microorganisms like yeast intracellular and extracellular secretion (yields up to 15g/L) and bacteria intracellular soluble and inclusion body (yields as high as 10g/L) We have also created a Interferon-Beta (IFN-Beta) Manufacturing fermentation system to develop bacteria-based vaccines We are experts in optimizing processes increasing yields as well as reducing production costs Utilizing a strong technology team we ensure timely and quality project delivery to bring your exclusive products to market faster