Desenvolvimento e fabricação de DNA de minicírculo

• Avanços no desenvolvimento de DNA de minicírculos para aplicações biomédicas

  A substituição de peças danificadas é outro aspecto crucial. Estes são chamados de medicamentos regenerativos. A recuperação/cura da(s) parte(s) ferida(s) ou doente(s) do corpo está vinculada a eles, e a medicina regenerativa inibe tal recuperação. Os pesquisadores estão usando o DNA do minicírculo como parte de novas terapias destinadas a doenças como doenças cardíacas, distúrbios hepáticos e vários outros problemas de saúde.

• Produção simplificada de DNA de minicírculos para ensaios clínicos

  As pessoas devem primeiro testar novos tratamentos através de ensaios clínicos antes de estarem disponíveis. Os ensaios clínicos são estudos de pesquisa que investigam se os tratamentos em uso experimental são seguros e quão bem funcionam. Esses ensaios clínicos geralmente utilizam centenas de pacientes e podem durar anos. Este é um passo importante para garantir que os tratamentos sejam seguros para todos.

• Fabricação eficiente de DNA de minicírculo para terapêutica acessível

  A produção de quantidades adequadas de DNA de minicírculos para cada teste em ensaios clínicos é uma das razões pelas quais a abordagem apresenta um desafio. Felizmente, os cientistas estão descobrindo maneiras inovadoras de agilizar o processo. Na verdade, eles estão tentando encontrar novas maneiras de produzir DNA de minicírculos de maneira mais rápida e melhor. Permitir que isto aconteça deverá reduzir os custos e os prazos para os testes, mas, mais importante ainda, disponibilizará novos tratamentos aos pacientes mais rapidamente, o que deve ser uma coisa boa quando algumas pessoas estão desesperadas.

Por que escolher o desenvolvimento e fabricação de DNA do Yaohai Minicircle?

• Sistema de Qualidade e Conformidade Regulatória Global

  Yaohai BioPharma is a Top 10 Microbial CDMO that incorporates Minicircle DNA Development and Manufacturing as well as regulatory affairs. We have a quality management system which is in line with current GMP standards as well as global regulations. Our team of regulatory experts is proficient in global regulatory frameworks to accelerate biological launches. We ensure traceable production processes quality products, as well as complying with the rules of the US FDA and EU EMA. Australia TGA and China NMPA are also satisfied. Yaohai BioPharma has successfully passed the audit on site of the European Union's Qualified Person (QP) for our GMP quality system as well as our production facility. Furthermore, we have cleared the first certification audits of the ISO9001 Quality Management System, ISO14001 Environmental Management System, and ISO45001 Occupational Health and Safety Management System.

• Conhecimento Profissional e Ampla Experiência

  Yaohai Bio-Pharma is a leading Microbial biologics CDMO. We have been focused on microbial-produced therapeutics and vaccines for human, veterinary, and the management of pet health. We are equipped with Minicircle DNA Development and Manufacturing RD platforms as well as manufacturing technology that encompass the entire process beginning with the development of microbial strains cells, methods and processes, to commercial and clinical manufacturing which ensures successful implementation of cutting-edge solutions. We have acquired a large amount of experience in bio processing of microbial cells. We have delivered over 200 global projects, and help our clients with navigating the laws from the US FDA, EU EMA, Australia TGA, and China NMPA. Our professional expertise and extensive experience allows us to quickly respond to market demands and provide tailored CDMO services.

• Cadeia de suprimentos robusta e capacidades de fabricação

  Yaohai Bio-Pharma, a top 10 Minicircle DNA Development and Manufacturing of biological products, is a specialist in microbial fermentation. We have set up a modern facility that has robust RD capabilities and advanced infrastructure. Five lines of production for drugs conforming to GMP standards to purify and ferment microbial cells along with two fill and finish lines for vials as well as cartridges and needles pre-filled are readily available. The fermentation scales available for use range from 100L to 2000L. Filling specifications for vias are 1ml to 25ml, whereas pre-filled syringe or cartridge filling requirements are between 1-3ml. The production workshop is cGMP certified and offers the availability of commercial and clinical samples. The large molecules manufactured in our facility are available for delivery worldwide.

• Personalização, eficiência e relação custo-benefício

  Yaohai Bio-Pharma has experience in the production of biologics created from Minicircle DNA Development and Manufacturing. We offer customized RD and manufacturing solutions while making sure that there are no risks. We have been involved in diverse modalities such as subunit vaccines recombinant, peptides hormones, cytokines, growth factors, single-domain antibodies enzymes, plasmid DNA MRNA, and many more. We are a specialist in many microorganisms, including yeast extracellular and intracellular secretion (yields up to 15g/L) as well as bacteria intracellular soluble and inclusion body (yields as high as 10g/L). We have also created a BSL-2 fermentation platform to create bacterial vaccines. We focus on improving processes, increasing product yields, and reducing production costs. Utilizing a strong technology team, we can ensure prompt and reliable project delivery that will bring your product to market faster.

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