GMP G-CSF Manufacturing

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  Meeting regulatory requirements and guidelines

  Yaohai is registered with GMP This means we adhere to rules from the government that are made to keep people safe. What these regulations do is make sure that the medications we create are risk-free for everybody. An example is that we always are following safety gear when working on real world. We, strike to work places clean and neat, in a place where we are making medicine this is very important. Furthermore, we ensure to dispose of waste generated by our processes in the right way. We self-audit are processes and bring in experts from outside the co-op to review our work. THis GMP Semaglutide-productie allows us to somewhat guarantee our high level of safety requirements.

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  Reliable and efficient manufacturing processes

  Our facility is customer focused and service oriented. GMP G-CSF is produced in a controlled and orderly manner due to we always want it to be of the highest quality. Our production process is robust and efficient. That enables us to make a lot of perfectly efficient and safe medicine. Efficiency means we get to more patients, and make sure that our product is there when it's needed most.

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  Meeting the needs of patients and healthcare providers

  GMP G-CSF is primarily used to assist patients suffering from low white blood cell counts, particularly those on chemotherapy. It is significant as low white blood cell counts can make FGFR inhibitors less effective and become especially challenging to patients who are attempting to fight off infections. We recognize the importance of administering treatment promptly to patients. The GMP Anti-CD8 VHH-productie medicine has to get to the people and we have designed our medicine such that it can be taken through any accepted route. We ensure the availability of our medicines for people who need it, working closely with doctors and healthcare providers. It helps in terms of A good customer service team who is ready to solve any query or issue on the product. We understand that proper communication is essential to serving our customers.

Why choose Yaohai GMP G-CSF Manufacturing?

• Kwaliteitssysteem en wereldwijde naleving van regelgeving

  Yaohai BioPharma is a Top 10 Microbial CDMO that integrates quality management and regulatory affairs. We have a quality management system that is in compliance with current GMP G-CSF Manufacturing and regulations around the globe. Our regulatory team is knowledgeable in the global regulatory frameworks that help accelerate biological launches. We ensure traceable production procedures quality products, as well as in compliance with the guidelines of the US FDA and EU EMA. Australia TGA and China NMPA are also in compliance. Yaohai BioPharma has successfully passed the on-site audit by the European Union's qualified Person (QP) for our GMP quality system and production site. We also successfully cleared the first certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.

• Professionele expertise en uitgebreide ervaring

  Yaohai Bio-Pharma, a leader in CDMOs for microbial biologics, is located in Jiangsu. We are focusing on microbially produced therapeutics and vaccines that are GMP G-CSF Manufacturing for human, veterinary as well as pet health management. We have the most cutting-edge RD platforms as well as manufacturing technology that cover the entire manufacturing process, from microbial strain development, cell banking, process and method development to clinical and commercial manufacture which ensures successful production of novel solutions. We have gained an extensive amount of experience in bio processing of microbial cells. More than 200 projects have been successfully completed, and we support our clients in get through regulations, such as those of US FDA as well as EU EMA. We also aid them with Australia TGA and China NMPA. Our experience and professional knowledge as well as our extensive knowledge allow us to quickly respond to market demands and provide customized CDMO services.

• Robuuste toeleveringsketen en productiecapaciteiten

  GMP G-CSF Manufacturing is a Top 10 biotech company specializing in microbiological fermentation. We have built a modern facility with strong RD capabilities and modern manufacturing facilities. Five production lines for pharmaceuticals in line with GMP standards for microbial purification and fermentation along with two automated fill and finish lines for vials and cartridges and pre-filled needles are available. The fermentation scales available are 100L, 500L, 1000L, to 2000L. Specifications for filling vials range from 1ml up to 25ml. the pre-filled syringes and cartridge filling specifications cover between 1-3ml. The workshop for production is cGMP compliant, and guarantees a stable supply of commercial products and clinical samples. Our factory produces large molecules that are shipped around the world.

• Maatwerk, efficiëntie en kosteneffectiviteit

  GMP G-CSF Manufacturing has experience in manufacturing biologics that are that are derived from microorganisms. We provide tailored RD as well as manufacturing solutions, while minimising the risk. We have experimented with a variety of techniques, such as recombinant cellular subunits of vaccines (including peptides), growth factors, hormones and the cytokines. We have specialized in multiple microorganisms like yeast extracellular and intracellular secretion (yields up to 15g/L) and bacteria intracellular soluble and inclusion bodies (yields up to 10g/L). We also have the BSL-2 fermentation platform to develop bacterial vaccines. We are experts in improving processes, increasing product yields, and decreasing production costs. With an effective technology team, we ensure timely and quality project delivery and bring your products to market faster.

Gerelateerde productcategorieën

• GMP GLP-1GIP Tirzepatide API
• GMP-plasmide-DNA-productie
• GMP Semaglutide-API
• GMP Semaglutide-productie
• GMP-productie van vaccins met virusachtige deeltjes (VLP)
• GMP Anti-CD8 VHH-productie
• GMP Anti-EGFR VHH-productie
• GMP Anti-HER3 VHH-productie
• GMP Anti-MMRCD206 VHH
• GMP Anti-PD-1PD-L1 VHH

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