지속형 인슐린 개발 및 상용화 대한민국

• 지속형 인슐린을 글로벌 시장에 출시

  혈당 수치를 조절하는 것 외에도, 오래 지속되는 인슐린은 당뇨병으로 인한 다른 심각한 건강 문제(예: 심장병, 실명, 신부전)의 위험을 줄일 수 있습니다. 공복 혈당 수치: FBS 빠른 개시 전류의 변화를 확인하는 방법은 일반적으로 잠자기 전에 이루어지며, 10~12시간 후에는 술을 마시거나 식사를 한 후 사용할 수 있습니다(일반적으로 밤 XNUMX시). 건강만 걱정하는 것이 아니라 삶을 더 많이 경험하게 해주기 때문에 매우 중요합니다.

• 지속성 인슐린의 조절 경로 탐색

  그곳에서는 세계보건기구(WHO) 및 국제당뇨병연맹(IDF)과 같은 단체들이 전 세계적으로 당뇨병을 앓고 있거나 발병 위험이 높은 사람들이 지속형 인슐린에 더 쉽게 접근할 수 있도록 노력하고 있습니다. 그들은 우리 모두가 건강을 유지하는 데 필요한 약을 얻을 수 있도록 부지런히 노력하고 있습니다.

• 오랫동안 지속되는 인슐린 혁신

  그러나 또 하나의 잠재적인 게임 체인저(game-changer)는 "스마트" 인슐린의 개발입니다. 스마트 인슐린은 혈당 수치의 변화에 ​​따라 자동으로 이노반드를 제공하므로 이에 따라 약물의 크기가 조정됩니다. 이는 당뇨병 환자가 더 이상 하루 종일 설탕 수치를 모니터링할 필요가 없음을 의미할 수도 있습니다. 그 자체로 큰 불편함을 안겨줍니다.

Yaohai 지속형 인슐린 개발 및 상용화를 선택하는 이유는 무엇입니까?

• 품질 시스템 및 글로벌 규정 준수

  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.

• 강력한 공급망 및 제조 역량

  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.

• 전문적 전문성과 폭넓은 경험

  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.

• 맞춤화, 효율성 및 비용 효율성

  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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