Desenvolvimento e comercialização de insulina de ação prolongada

• Trazendo insulina de ação prolongada para o mercado global

  Além de controlar os níveis de açúcar no sangue, a insulina de longa duração pode reduzir o risco de outros problemas graves de saúde decorrentes do diabetes (como doenças cardíacas, cegueira e insuficiência renal). Níveis de açúcar no sangue em jejum: FBS A prática de verificar a mudança na corrente de início rápido é normalmente feita antes de dormir, após 10-12 horas, você pode usar depois de beber ou jantar - normalmente oito horas da noite. É tão vital porque lhes permite vivenciar mais a vida, em vez de ficarem apenas preocupados com a saúde.

• Navegando no caminho regulatório da insulina de ação prolongada

  Lá, grupos como a Organização Mundial da Saúde (OMS) e a Federação Internacional de Diabetes (IDF), entre outros, estão trabalhando para tornar a insulina de ação prolongada mais acessível para pessoas com ou que vivem em alto risco de desenvolver diabetes em todo o mundo. Eles estão sendo diligentes para garantir que todos possam obter os medicamentos de que precisamos para nos mantermos saudáveis.

• Inovações em insulina de ação prolongada

  Mas uma outra potencial mudança de jogo é a criação da insulina “inteligente”. A insulina inteligente vem automaticamente junto com as alterações nos níveis de açúcar no sangue, o que faz com que o medicamento ajuste seu tamanho de acordo. Isto também poderia significar que as pessoas com diabetes não precisariam mais monitorar seus níveis de açúcar ao longo do dia; um grande inconveniente por si só.

Por que escolher o desenvolvimento e comercialização de insulina de ação prolongada Yaohai?

• Sistema de Qualidade e Conformidade Regulatória Global

  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.

• Cadeia de suprimentos robusta e capacidades de fabricação

  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.

• Conhecimento Profissional e Ampla Experiência

  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.

• Personalização, eficiência e relação custo-benefício

  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

Categorias de produtos relacionados

Não encontra o que procura?
Contate nossos consultores para mais produtos disponíveis.