We have various cell culture processes, such as adherent cell culture based on flasks (T25/T75/T175/T225), cell factories (1 layer /5 layers /10 layers), fixed bed bioreactors, and microcarriers, etc. suspension cell culture based on shake flasks (125ml/250ml/500ml/1000ml/2000ml/5000ml), wave bioreactor, stirring tank, etc., to meet the process development needs of the upstream cell production of gene therapy products. The largest culture volume up to 200L .
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Experience in research and development and large-scale preparation of various viral vectors, such as adenovirus(Adv), vaccinia virus (VV), lentivirus(LV), herpes virus(HSV), adeno-associated virus(AAV), newcastle disease virus(NDV), etc.. The preparation of viral vectors can be by serum-containing or serum-free processes. The culture scale of the fixed bed bioreactor process is 1.5L~10L; the culture scale of the wave bioreactor process is 1L~25L; the culture scale of the stirring tank process is 1L~200L. Customers can choose different preparation processes and culture scales according to their needs.
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The pilot-scale process is used to complete the production of pilot-scale samples for clinical application of new drugs such as adenovirus, poxvirus, lentivirus, herpes virus, adeno-associated virus, and Newcastle disease virus in the GMP workshop, including: research on raw materials for production, research on drug stock solution or APIs(Active pharmaceutical ingredient) production process, research on formulation and process, research on product quality, manufacture and verification of samples for clinical research application, preliminary stability research, etc.
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According to customer requirements, small-volume liquid injection preparations of different volumes (0.2ml~3ml) that meet GMP production requirements are packaged. Other volumes can be customized and modified. The filling speed can reach nearly 10,000 per hour.
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Our GMP production platform conducts the production and quality control of gene therapy clinical samples according to GMP specifications, and the production process complies with the regulatory supervision of GMP production and new drug application requirements. The platform is equipped with multi-brand international mainstream equipments to complete the production of clinical-grade plasmid and virus products which meet the needs of phase I, II, III, and IV clinical trials.
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Based on the company's research and development platform, and according to the requirements of the project and the quality attributes of the product. The detail and scientific quality research protocol is formulated. Timely track and follow up on domestic and foreign regulatory requirements and new technical quality criteria to meet the quality research content of various application requirements.
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Yuanxing Gene has rich experience in research and development and production of viral vector drugs and mRNA drugs. It is a CDMO/CMO company that develops the most varieties of viral vector and obtains the most clinical approvals in the field of outsourcing services for viral vector drugs in China at present, and some viral vector products have entered the late stage of clinical trials or even listed.
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mRNA , also known as messenger ribonucleic acid, the most important role is to directly guide the synthesis of proteins through the process of replication, transcription and translation, that is, to replicate the genetic information carried by DNA in the nucleus , and then transcribe into the cytoplasm and translate into protein. Since more than 90% of human diseases are related to proteins and based on the characteristics of mRNA, mRNA medicine is of great significance and value.
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