GMP Adenovirus Vectors Production

GMP Adenovirus Vectors Production

Recombinant adenovirus (Ad) vectors provide a highly versatile system for mammalian gene transfer and are extensively used in vaccine development and a variety of gene therapy applications, particularly for gene-based therapy of cancer, including immunotherapy. These applications are facilitated by several important advantages of Ad over other vectors, including (1) convenient and simple methods of vector construction, (2) efficient production to high yields in well-defined cell systems, (3) efficient transduction of proliferating and quiescent cells, and (4) high stability, allowing purification and long-term storage.

Adenoviral vector-based vaccines are intensively studied because of their potential to prevent infectious diseases for which current vaccines are suboptimal (such as anthrax and influenza vaccines) or for which licensed vaccines are not available (such as malaria and human immunodeficiency virus [HIV]). Once adenovirus vector-based vaccines will be licensed for the prevention of infectious diseases, manufacturing methods capable of reliably delivering large numbers of vaccine doses will be required. The expanding potential commercial product pipeline and the continuously advancing development of recombinant adenoviral vectors for gene therapy require that products are well characterized and consistently manufactured to rigorous tolerances of purity, potency and safety. With the recent increase in biopharmaceutical funding in gene therapy, industry partners are requiring their academic counterparts to meet higher levels of GMP compliance at earlier stages of clinical development.

For over a decade, QVirus™ Platform at Creative Biogene has considerable expertise in all aspects of adenoviral vector technology, from the design of vector constructs, through current Good Manufacturing Practices (cGMP), to pre-clinical applications, and associated quality assurance/control and regulatory issues. QVirus™ Platform has developed 293T and HEK293 producer cell lines for both adherent and suspension culture GMP adenoviral vector production methods. Besides, we will guide your selection of cell line and culture condition based on the size of your transgene and the quantity of GMP adenovirus required.

Service Highlights

➢ Considerable experience in the construction and production of various generations of adenoviral vectors
➢ Elements include raw materials, plasmids, cell line, MCB/WCB, upstream/downstream process, analytics, batch records, SOP's, trained staff
➢ Up to 250 L yields (gene of interest vector dependent)
➢ Integrated in-process and release testing performed onsite

QVirus™ Platform has the expertise to assist you with the GMP manufacture of adenovirus vectors. If you have any special requirements, please feel free to contact us.

References
1. Vellinga J, et al. Challenges in Manufacturing Adenoviral Vectors for Global Vaccine Product Deployment. Human Gene Therapy, 2014, 25(4):318-327.
2. Van d L J C M, Wright J F. Progress and Challenges in Viral Vector Manufacturing. Human Molecular Genetics, 2015:ddv451.

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