Vývoj a komercializace dlouhodobě působícího inzulínu Česká republika

• Bringing Long-Acting Insulin to the Global Marke

  In addition to controlling your blood sugar levels, long-lasting insulin can reduce the risk of other serious health problems from diabetes (like heart disease, blindness and kidney failure). Fasting blood sugar levels: FBS The practice of ascertaining the change in fast onset current is normally made before sleeping, after 10-12 hours you can use from drinking or dining - typically eight o'clock overnight. It is so vital because it allows them to experience life more instead of only being anxious about their health.

• Navigating the Regulatory Pathway of Long-Acting Insulin

  There, groups such as the World Health Organization (WHO) and International Diabetes Federation (IDF), among others are working to make long-acting insulin more accessible for people with or living at high risk of developing diabetes around the world. They are being diligent to make sure that everybody is able to get the medications that we need in order for us stay healthy.

• Long-Acting Insulin Innovations

  But one other??potential game-changer is the creation of "smart" insulin. Smart insulin automatically comes inobande withn changes in blood sugar levels, which causes the medication to adjust its size accordingly. This could also mean that people with diabetes would no longer need to monitor their sugar levels throughout the day; a major inconvenience in and of itself.

Why choose Yaohai Long-acting Insulin Development and Commercialization?

• Systém kvality a dodržování globálních předpisů

  Yaohai BioPharma is a Top 10 Microbial CDMO that incorporates quality control and regulatory matters. We have a quality system which is in line with current GMP standards and international regulations. Our regulatory team is knowledgeable in global regulatory frameworks to accelerate biological launches. We ensure traceable manufacturing processes and top-quality products that are compliant with the requirements of the US FDA, EU EMA, Australia TGA, and Long-acting Insulin Development and Commercialization. Yaohai BioPharma has successfully passed the audit on site of the European Union's qualified Person (QP) for our GMP quality system and production site. In addition, we've cleared the first certification audits of the ISO9001 Quality Management System, ISO14001 Environmental Management System, and ISO45001 Occupational Health and Safety Management System.

• Robustní dodavatelský řetězec a výrobní kapacity

  Yaohai Bio-Pharma is a Top 10 biological company that specializes in Long-acting Insulin Development and Commercialization. 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.

• Profesionální odbornost a rozsáhlé zkušenosti

  Yaohai Bio-Pharma is a leading microbial biologics CDMO. Our main focus has been the production of Long-acting Insulin Development and Commercialization 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.

• Přizpůsobení, efektivita a hospodárnost

  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 Long-acting Insulin 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

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