Viral Vectors are the tool which is commonly used to deliver genetic material into desired cells in both in-vivo and in-vitro conditions. These viral vectors are mainly of four types namely retroviruses, lentiviruses, adenoviruses and adeno-associated viruses. These viruses are largely being used in gene therapy, which is a technique that corrects defective genes responsible for the development of the certain genetic disease.
The gene therapy for such disease involves a process of gene transfer to the desired cell with the help of viral vector. Currently, gene therapy has emerged as the potential treatment options for genetic and non-curable disease such as cancer and some viral infections. In gene therapy, patient’s samples are extracted, transduced and modified with viral vectors and re-implanted in patients for the therapeutic applications.
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Owing to the immense potential of gene therapy, the use of viral vectors has increased significantly over the years. In order to fulfill the current need of viral vectors, the manufacturing of such vectors has increased in recent years. There are two approached for the manufacturing of viral vectors i.e. scale-out of adherent-cell systems based on 2D planar technologies and scale-up of 3D suspension cell cultures in stirred-tank bioreactors.
The viral vector development process involves generation of cell lines and cell transfection with plasmids to produce viral vectors. These viral vectors are then transduce with patients T cells and then re-introduce in the patient’s body. The manufacturing process of viral vectors involves three or more manufacturers for the development of cell lines, plasmids, lentiviral vector, and cell manipulations.
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With the evolution of gene therapy, new vectors and its application are expected to be explored and new agents to be discovered in coming years. Moreover, the involvement of new advanced technologies such as MP-Seq would emerge as boosted for the development of viral vectors. There are some factors that impede the market such as the stringent government regulations leading to the delayed approval of products.
The manufacturing of viral vectors needs to follow some regulatory requirements such as critical raw material control. The U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and the Japanese Pharmaceuticals & Medical Devices Agency (PMDA) have set few regulatory guidelines for the development if viral vectors.
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Similarly, the testing for the raw materials such as cell lines, plasmids, process intermediates, and other drug substances must be performed to good laboratory practice (GLP).
By region, viral vector development service market is segmented into five regions: North America, Latin America, Europe, Asia-Pacific and the Middle East & Africa. North America dominates the global viral vector development service market owing to the advanced healthcare infrastructure, high investment on research and development and early adoption of advanced therapies and solutions for critical diseases.
Few of the player in the viral vector development service market are FUJIFILM Diosynth Biotechnologies, Sanofi, Spark Therapeutics, uniQure, MassBiologics, FinVector, Brammer Bio, Cell and Gene Therapy Catapult and Cobra Biologic among others.
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