Enzymes are special molecules which help chemical reactions happen in our bodies — an understanding that scientists have only come to appreciate since the early 20th century. Not only are these enzymes critical for everyday functioning, but they can also be harnessed for the treatment of a variety of diseases — which is pretty cool! The biotech company Yaohai is focusing its efforts on engineering new enzyme therapies aimed at an array of health problems.
Some of the enzymes are already used as therapeutics. For example, they help dissolve clots in the blood during a heart attack, which is potentially life-threatening. The research team is currently investigating the potential for enzymes to be used to treat different forms of cancer or inherited diseases. At one end of the spectrum, these diseases are very challenging to treat and this is an important thing. Enzymes can be custom-designed to attack virtually any cell or protein within the body, which makes them efficient for treating most of the illnesses. The ability to address particular regions makes enzyme treatments also safer and associated with fewer side effects than traditional drugs.
This journey starts with research and development. For more specific diseases, at Yaohai, scientists work to design and test new enzymes. When they identify a promising candidate enzyme by those standards, then they begin to test it first in the lab, and then on animals. This is to ensure that the enzyme is safe and functions properly before testing it on humans.
If the enzyme performs well in those initial tests, they will advance to clinical trials. Why are clinical trials necessary when testing the enzyme in humans to see if it is safe and effective? This process often takes years and requires the participation of many workers — sometimes hundreds or even thousands of patients. This is one of the key things to remember in order for this new treatment to reach those who need it.
Enzyme therapies can also help treat historically treatment-resistant diseases like genetic disorders. Through the mechanism of action being more heavily focused on certain genes, enzymes are able to correct genetic abnormalities and overall buffering against disease progression and further complications affecting patient healthspan and quality of life. This is an awesome potential for numerous who have been battling with these conditions for a very long time.
Further, better understanding of the applications of enzyme therapies for different diseases needs more research. Although there are a lot of nice studies suggesting that it might be very helpful, we still have a long way to go before understanding how we can systematically use enzymes in therapy for various diseases. What scientists are doing is finding other ways of putting cancer-vaccine therapies to their ultimate test.
Nevertheless, Yaohai is determined to bring his enzyme therapies to as many patients in need as possible. They have an indomitable spirit and they plan to keep plugging away in R&D because they feel that enzyme therapies offer true promise for millions of people. This ability is not infallible, but with the use of appropriate dedication and innovation, enzyme therapies literally have no limit.
Yaohai Bio-Pharma is experienced in biologicals derived from microbial sources We offer bespoke RD solutions as well as manufacturing services while minimising potential risks We have been involved in numerous modalities like subunit vaccines recombinant peptides hormones cytokines growth factors single domain antibodies enzymes plasmid DNA the mRNA and other We've specialized in several microorganisms like yeast extracellular and intracellular Therapeutic Enzyme Development and Commercialization (yields up to 15g/L) and intracellular soluble bacteria and inclusion body (yields as high as 10g/L) We also have the BSL-2 fermentation platform to create bacterial vaccines We focus on optimizing processes increasing product yields and reducing costs We have an efficient technology team that guarantees timely and high-quality delivery of projects This helps us bring your unique products faster to market
Yaohai Bio-Pharma, a top 10 producer of biological products, is a specialist in microbial fermentation. We have built an advanced facility that is equipped with advanced facilities as well as robust RD and manufacturing capabilities. Five drug substance production lines that are compliant with GMP standards for microbial purification and fermentation along with two automated fill and finishing lines for vials, cartridges and needles pre-filled are available. The scales for fermentation available are 100L, 500L, 1000L and 2000L. The filling volume ranges from 1ml to Therapeutic Enzyme Development and Commercialization. Syringes or cartridges pre-filled are filled with the equivalent of 1-3ml. Our cGMP-compliant production workshop ensures steady supply of clinical samples and commercial products. The bulk molecules produced in our factory can be shipped worldwide.
Yaohai Bio-Pharma, a leader in CDMOs for microbial biologics, is located in Jiangsu. We are focusing on microbially produced therapeutics and vaccines that are Therapeutic Enzyme Development and Commercialization for human, veterinary as well as pet health management. We have the most cutting-edge RD platforms as well as manufacturing technology that cover the entire manufacturing process, from microbial strain development, cell banking, process and method development to clinical and commercial manufacture which ensures successful production of novel solutions. We have gained an extensive amount of experience in bio processing of microbial cells. More than 200 projects have been successfully completed, and we support our clients in get through regulations, such as those of US FDA as well as EU EMA. We also aid them with Australia TGA and China NMPA. Our experience and professional knowledge as well as our extensive knowledge allow us to quickly respond to market demands and provide customized CDMO services.
Yaohai BioPharma is a Top 10 Microbial CDMO that incorporates Therapeutic Enzyme Development and Commercialization as well as regulatory affairs. We have a quality management system which is in line with current GMP standards as well as global regulations. Our team of regulatory experts is proficient in global regulatory frameworks to accelerate biological launches. We ensure traceable production processes quality products, as well as complying with the rules of the US FDA and EU EMA. Australia TGA and China NMPA are also satisfied. Yaohai BioPharma has successfully passed the audit on site of the European Union's Qualified Person (QP) for our GMP quality system as well as our production facility. Furthermore, we have cleared the first certification audits of the ISO9001 Quality Management System, ISO14001 Environmental Management System, and ISO45001 Occupational Health and Safety Management System.