Entwicklung und Vermarktung von langwirksamem Insulin Deutschland

• Lang wirkendes Insulin auf den Weltmarkt bringen

  Neben der Kontrolle Ihres Blutzuckerspiegels kann Langzeitinsulin das Risiko anderer schwerwiegender gesundheitlicher Probleme durch Diabetes (wie Herzkrankheiten, Blindheit und Nierenversagen) senken. Nüchternblutzuckerspiegel: FBS Die Messung der Veränderung des Fast-Onset-Stroms erfolgt normalerweise vor dem Schlafengehen, 10-12 Stunden nach dem Trinken oder Essen – normalerweise XNUMX Uhr nachts. Dies ist so wichtig, weil Sie dadurch das Leben mehr genießen können, anstatt sich nur um Ihre Gesundheit zu sorgen.

• Navigieren im regulatorischen Pfad von langwirkendem Insulin

  Dort arbeiten Organisationen wie die Weltgesundheitsorganisation (WHO) und die Internationale Diabetes-Föderation (IDF) daran, langwirkendes Insulin für Menschen mit Diabetes oder mit hohem Diabetesrisiko weltweit zugänglicher zu machen. Sie tun ihr Möglichstes, um sicherzustellen, dass jeder die Medikamente bekommt, die wir brauchen, um gesund zu bleiben.

• Innovationen bei langwirkendem Insulin

  Ein weiterer potenzieller Wendepunkt ist die Entwicklung von „intelligentem“ Insulin. Intelligentes Insulin wird automatisch bei Veränderungen des Blutzuckerspiegels freigesetzt, was dazu führt, dass das Medikament seine Größe entsprechend anpasst. Dies könnte auch bedeuten, dass Diabetiker ihren Blutzuckerspiegel nicht mehr den ganzen Tag über überwachen müssen, was an und für sich schon eine große Unannehmlichkeit wäre.

Warum sollten Sie sich für die Entwicklung und Vermarktung von Langzeitinsulin von Yaohai entscheiden?

• Qualitätssystem und Einhaltung globaler Vorschriften

  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.

• Robuste Lieferkette und Fertigungskapazitäten

  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.

• Fachkompetenz und langjährige Erfahrung

  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.

• Anpassung, Effizienz und Kosteneffizienz

  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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