Signing Ceremony of Strategic Cooperation between PackGene and Pall for China Gene Therapy CDMO
With the vision of “Helping Gene Therapy “, PackGene focuses on the development and large-scale production of AAV viral vectors, and provides industry-leading CDMO services for gene therapy research and clinical uses. Since its establishment, PackGene has continued to innovate, accelerate and promote the construction of a large-scale production platform for AAV vector to meet the industrial demand for high-efficiency AAV vectors that meet GMP requirements.
With the mission of “making gene therapy affordable”, PackGene is committed to meeting the booming innovative gene therapies’ demand for AAV vectors to reduce production costs worldwide. The 1500 m2 GMP production base of PackGene which is located at Huangpu District, Science City, Guangzhou Development Zone was officially put into use on October 1, 2020, serving AAV’s IIT and IND projects. In addition, PackGene is building a gene therapy GMP production base with an area of 8,000 m2 (the project is named “Kun Base”). The base adopts internationally leading design concepts and architecture to meet the requirements of the US FDA, EU EMA, and Japan FDA. The clean workshop of “Kun Base” adopts C+A and B+A environment, so that the virus and plasmid workshop building areas are completely separated to avoid cross-contamination or influence. It is said that the “Kun Base” of PackGene will be officially put into production in the first half of 2021, and it can achieve an annual AAVoutput of >1×10^19vg/year.
The PackGene’s AAV virus production plant “Kun Base” covers an area of 4000 m2, including 4 large-scale AAV production lines, to meets the needs of customers for adherent culture and suspension culture process routes simultaneously; the area of the plasmid production plant is 4000 m2, including 2 GMP plasmid production lines, process development (PD), vector research and development, etc. After the “Kun Base” is put into production, PackGene’s AAV vectors production process with core advantages will be applied in a wider range. The reason why PackGene is leading in AAV production technology is that in addition to innovation in basic research & development (R&D) and process R&D, it also benefits from the continuous development of AAV quality research and analysis as well as assay technology. The mastered skills of advanced analytical methods that have been used in multiple clinical projects.
At present, gene therapy R&D and clinical projects have sprung up like mushrooms. At present, 13 gene therapy drugs have been approved and used to treat different diseases worldwide. Pall upholds the mission of “the promoter of China’s biotechnology” and has been committed to empowering biopharmaceutical R&D and production processes, aiming to help customers with high-quality products and services to greatly reduce the R&D and manufacturing cost of biopharmaceuticals, shorten the time to market, while meet increasingly stringent laws and regulations, and realize the vision of saving patients’ lives and improving patients’ quality of life. Pall provided PackGene with a dual-line production platform technology including attachment and suspension. Currently PackGene has Pall iCellis 500 series, XPANSION 200 series, and STR200 series bioreactors. Through strategic cooperation, Pall will also provide PackGene with more comprehensive upstream manufacturing solutions to meet more needs of gene therapy companies.
PackGene is a national high-tech enterprise featuring “High Quality Fast Delivery Responsive Service ” and focuses on AAV virus packaging and AAV-based gene therapy CDMO services. It is headquartered in Guangzhou Economic and Technological Development Zone, The U.S. branch is located in Worcester, Massachusetts. The company provides AAV gene therapy-based process development and GMP production services, as well as AAV packaging and vector cloning services for researchers. PackGene’s CDMO service supports multiple directions of gene therapy, such as gene editing, gene activation, RNAi, gene overexpression, non-coding RNA, etc., as well as in vivo or in vitro treatment strategies, providing various technology services ranging from plasmid construction , bacterial banking, and cell banking , process development to large-scale AAV production, process transfer, methodological transfer, IND application pharmaceutical research data writing and other technical services, to meet the unsatisfied needs of AAV-based gene therapy from IND application to clinical trial stage, from rare diseases to common diseases treatment development.
About Pall Corporation
Pall Corporation is a subsidiary company of the Danaher (NYSE: DHR). Pall global employees are united and committed to solving customers’ challenges in filtration, separation and purification, and to promote the advancement of health, safety and environmental technology. Pall provides a wealth of technologies and solutions to safeguard health, protect critical operating assets, improve product quality, and minimize emissions and waste. Pall’s life sciences and industrial teams specialize in serving many customers in a variety of industries, including biotechnology, pharmaceuticals, medical, food and beverage, laboratory, microelectronics, aerospace, fuels, petrochemical, chemical, automotive, and power generation.
Pall (China) Co., Ltd. is a wholly-owned enterprise of Pall Group in China. After more than 20 years of development in China, it has grown from a company focusing on filtration products to an expert in filtration, separation and purification solutions. From upstream R&D to mass production, from pre-sales technical support to after-sales service, from product sales to providing overall solutions, Pall not only provides customers with high-tech products and applications, but also plays a pioneering role in authoritative technology and innovative quality.