Interferon-alpha (IFN-alpha) Manufacturing

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  Developing innovative manufacturing techniques for IFN-alpha

  The first in our series begins with cells that have been engineered to overproduce IFN-alpha. These cells are grown in a bioreactor. After the cells have been grown, much needed effort goes into cleaning and carefully purifying our IFN-alpha through a series of dedicated steps. This it to make sure that the end solution is hygienic, durable, and can be used in medical applications.

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  Navigating regulatory requirements for IFN-alpha production

  Yaohai is committed to make high quality IFN-alpha available to all patients in the world and continue with our efforts on expanding production capacity. With state-of-the-art facilities and a team of professionals that is experienced in the field, we are ready to meet the increasing demand. Our goal is to ensure that IFN-alpha treatment can be delivered as soon and as effectively as possible and save the lives of infected patients.

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  Scaling up Interferon-alpha production for global distribution

  In summary, Interferon-alpha (IFN-alpha) is a critical protein the body possesses that helps us to combat with virus and many other threats. Due to advances in manufacturing practices and regulations concerning safety, IFN-alpha can be a significant therapeutic agent for many diseases including (chronic viral infections such as hepatitis C and cancer.

Why choose Yaohai Interferon-alpha (IFN-alpha) Manufacturing?

• Robust försörjningskedja och tillverkningskapacitet

  Yaohai Bio-Pharma is a Top 10 biological company that specializes in Interferon-alpha (IFN-alpha) Manufacturing. We have built a modern manufacturing facility with robust RD capabilities and modern manufacturing facilities. Five drug substance production lines complying with GMP standards for microbial fermentation and purification along with two fill and final lines for vials and cartridges as well as pre-filled needles are readily available. The available fermentation scales vary between 100L and 2000L. The filling volume ranges from 1ml up to 25ml. Syringes or cartridges that are pre-filled are filled with 3 to 3.5ml. Our production workshop that is cGMP-compliant ensures constant supply of clinical sample and commercial products. Our facility produces large molecules that are exported to all over the world.

• Kvalitetssystem och global regelefterlevnad

  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-alpha (IFN-alpha) 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.

• Anpassning, effektivitet och kostnadseffektivitet

  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 Interferon-alpha (IFN-alpha) Manufacturing (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

• Professionell expertis & lång erfarenhet

  Yaohai Bio-Pharma is a leading in microbial biologics CDMO. Our main focus has been the production of microbial vaccinations and therapeutics to manage the health of pets, humans and animals. health. We have modern RD and manufacturing technology platforms that cover the entire process, from microbial strain engineering, cell banking, process and method design to commercial and clinical manufacturing, which ensures the success supply of the most cutting-edge solutions. Through the years we have gained vast expertise in using microbial sources. Over 200 projects were successfully completed. In addition, we support our clients in get through regulations, such as those of the US FDA as well as EU EMA. We also help them to navigate Australia TGA and China NMPA. Our expert knowledge and vast experience allow us to quickly respond to market demands and provide Interferon-alpha (IFN-alpha) Manufacturing CDMO services.

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