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Get ahead of the evolving requirements of cell and gene therapy manufacturing, research, development.","_copy":"field_618a1b75ce04d","items_0_image":156635,"_items_0_image":"field_618a1b92ce04f","items_0_icon":159334,"_items_0_icon":"field_618a1b9bce050","items_0_title":"What Is Cell Therapy Manufacturing?","_items_0_title":"field_618a1bacce051","items_0_copy":"Cell therapy manufacturing is the process of turning cells into therapeutic agents through a number of bioprocessing steps that starts from collecting cells from a patient and ends with the administration or infusion of the final cell therapy product (CTP) to the patient.","_items_0_copy":"field_618a1bb0ce052","items_1_image":156638,"_items_1_image":"field_618a1b92ce04f","items_1_icon":159338,"_items_1_icon":"field_618a1b9bce050","items_1_title":"Cell Collection & Cryopreservation","_items_1_title":"field_618a1bacce051","items_1_copy":"Cell therapy manufacturing starts with the isolation of specific cells like stem cells, cancer-killing T-cells or natural killer (NK) cells. Cryopreservation at temperatures below \u2212130\u00b0C is a key enabling technology that provides stable and secure cell storage.","_items_1_copy":"field_618a1bb0ce052","items_2_image":156641,"_items_2_image":"field_618a1b92ce04f","items_2_icon":159342,"_items_2_icon":"field_618a1b9bce050","items_2_title":"Cell Reprogramming & Genetic Modification","_items_2_title":"field_618a1bacce051","items_2_copy":"At the heart of cell therapy manufacturing is cell reprogramming. Cells are genetically modified to increase their immune potency to kill disease-causing cells or to target a specific type of cancer by adding a certain receptor.","_items_2_copy":"field_618a1bb0ce052","items":3,"_items":"field_618a1b7dce04e"},"align":"wide","mode":"edit"},"attributesType":{"id":{"type":"string"},"name":{"type":"string"},"data":{"type":"object"},"align":{"type":"string"},"mode":{"type":"string"},"lock":{"type":"object"},"className":{"type":"string"}},"dynamicContent":""},{"innerBlocks":[],"name":"acf\/acf-repeating-image-copy-col-section","postId":155295,"blockType":{"name":"acf\/acf-repeating-image-copy-col-section","keywords":["repeating image copy col","unit","main","dd"],"attributes":{"id":{"type":"string"},"name":{"type":"string"},"data":{"type":"object"},"align":{"type":"string"},"mode":{"type":"string"},"lock":{"type":"object"},"className":{"type":"string"}},"providesContext":[],"usesContext":["postId","postType"],"selectors":[],"supports":{"align":"none","html":false,"mode":false,"anchor":false},"styles":[],"variations":[],"apiVersion":2,"title":"ACF Repeating Image Copy Col Section","description":"A block to display a repeating image copy col section.","category":"text","mode":"edit","align":"wide","post_types":[],"render_template":false,"render_callback":"","enqueue_style":false,"enqueue_script":false,"enqueue_assets":""},"originalContent":"","saveContent":"","order":2,"get_parent":{},"attributes":{"id":"block_6338575fc783a","name":"acf\/acf-repeating-image-copy-col-section","data":{"heading":"What are the steps in cell therapy manufacturing?","_heading":"field_618a1b66ce04c","copy":"","_copy":"field_618a1b75ce04d","items_0_image":156644,"_items_0_image":"field_618a1b92ce04f","items_0_icon":159345,"_items_0_icon":"field_618a1b9bce050","items_0_title":"Cell Selection & Modification","_items_0_title":"field_618a1bacce051","items_0_copy":"Cell therapy manufacturing begins with the collection of cells from the patient which often takes place in a clinical or apheresis facility. Specific cells are isolated to collect the needed components and then modified in order to target a specific type of cancer or other disease.","_items_0_copy":"field_618a1bb0ce052","items_1_image":156647,"_items_1_image":"field_618a1b92ce04f","items_1_icon":159348,"_items_1_icon":"field_618a1b9bce050","items_1_title":"Cell Culture","_items_1_title":"field_618a1bacce051","items_1_copy":"Cells are then cultured and transferred into a growth medium in order to generate enough cells for a single dose in an autologous therapy or hundreds of doses in an allogeneic therapy.\r\n\r\nThe cells are placed in an incubator where they continue to divide and grow in number which can take multiple weeks.","_items_1_copy":"field_618a1bb0ce052","items_2_image":156650,"_items_2_image":"field_618a1b92ce04f","items_2_icon":159351,"_items_2_icon":"field_618a1b9bce050","items_2_title":"Cell Harvest, Formulation, Fill & Finish","_items_2_title":"field_618a1bacce051","items_2_copy":"The cultured cells are washed, harvested, concentrated, and then formulated into the final therapeutic dose.","_items_2_copy":"field_618a1bb0ce052","items_3_image":156653,"_items_3_image":"field_618a1b92ce04f","items_3_icon":159354,"_items_3_icon":"field_618a1b9bce050","items_3_title":"Packaging, Shipping & Cryopreservation","_items_3_title":"field_618a1bacce051","items_3_copy":"The cell therapy products are transferred into vials and bags to begin preparation for delivery to the clinical setting.\r\n\r\nThe cell therapy products are then placed in a controlled-rate freezer (CRF) or cryobank for preservation without damaging the cells or placed in a cryo-shipper for delivery to the clinical setting.","_items_3_copy":"field_618a1bb0ce052","items":4,"_items":"field_618a1b7dce04e"},"align":"wide","mode":"edit"},"attributesType":{"id":{"type":"string"},"name":{"type":"string"},"data":{"type":"object"},"align":{"type":"string"},"mode":{"type":"string"},"lock":{"type":"object"},"className":{"type":"string"}},"dynamicContent":""},{"innerBlocks":[],"name":"acf\/acf-support-accordion-list","postId":155295,"blockType":{"name":"acf\/acf-support-accordion-list","keywords":["media","text","button","wds"],"attributes":{"id":{"type":"string"},"name":{"type":"string"},"data":{"type":"object"},"align":{"type":"string"},"mode":{"type":"string"},"lock":{"type":"object"},"className":{"type":"string"}},"providesContext":[],"usesContext":["postId","postType"],"selectors":[],"supports":{"align":"none","html":false,"mode":false,"anchor":false},"styles":[],"variations":[],"apiVersion":2,"title":"ACF Support Accordion List","description":"A block to display the support accordion list","category":"text","mode":"edit","align":"wide","post_types":[],"render_template":false,"render_callback":"","enqueue_style":false,"enqueue_script":false,"enqueue_assets":""},"originalContent":"","saveContent":"","order":3,"get_parent":{},"attributes":{"id":"block_633857d1c783f","name":"acf\/acf-support-accordion-list","data":{"section_0_category":"Other","_section_0_category":"field_619f29f386775","section_0_heading":"","_section_0_heading":"field_619f2a7586776","section_0_subsection_0_subject":"","_section_0_subsection_0_subject":"field_619f2aab86778","section_0_subsection_0_toggle_0_tags":"","_section_0_subsection_0_toggle_0_tags":"field_619f2b808677a","section_0_subsection_0_toggle_0_category":"","_section_0_subsection_0_toggle_0_category":"field_619f2b998677b","section_0_subsection_0_toggle_0_text":"How are gene therapies manufactured?","_section_0_subsection_0_toggle_0_text":"field_619f2bc98677c","section_0_subsection_0_toggle_0_copy":"Gene therapy is the use of genetic material in the treatment or prevention of disease. This may involve replacing or turning off genes that are causing medical problems, or adding genes to help the body to fight a certain disease.\r\n\r\nFrom discovery to development and manufacturing, gene therapy manufacturing involves very complex processes to produce highly engineered products.\r\n\r\nHere are four basic steps involved in gene therapy manufacturing:\r\n\r\n\u2022 Raw material preparation<\/strong>\r\n\r\nThis involves gathering all the elements needed to create a shell called a capsid, which houses or carries the functioning gene that will be delivered into the cells. The three elements needed are the vector genome, AAV (adeno-associated virus) protein, and helper proteins.\r\n\r\n\u2022 Upstream process<\/strong>\r\n\r\nIn the upstream process, the capsids are assembled and integrated with an inert virus, creating the viral vector that will ultimately be infused into patients.\r\n\r\nIn order to reproduce and reach the required concentration for harvesting, special cells are used as \u201chosts\u201d for the viral vector. This process involves scaling to a series of larger and larger batches until a final number of viral-containing host cells is achieved.\r\n\r\n\u2022 Downstream process<\/strong>\r\n\r\nIn the downstream process, the viral vector is purified, and all non-essential cellular material is removed.\r\n\r\nThis process involves harvesting the host cells, breaking them open to release their viruses, clarifying the preparation and removing impurities, and separating and purifying the viruses. The viral vector will also be reviewed and tested to ensure it\u2019s functioning properly.\r\n\r\n\u2022 Completion & packaging<\/strong>\r\n\r\nThe final stage of gene therapy manufacturing involves processing and packaging the viral vector to be sent away for clinical use. This consists of a series of precise steps largely carried out by automated robots in sterile lab facilities.","_section_0_subsection_0_toggle_0_copy":"field_619f2bdc8677d","section_0_subsection_0_toggle_1_tags":"","_section_0_subsection_0_toggle_1_tags":"field_619f2b808677a","section_0_subsection_0_toggle_1_category":"","_section_0_subsection_0_toggle_1_category":"field_619f2b998677b","section_0_subsection_0_toggle_1_text":"What are good manufacturing practices in cell therapy manufacturing?","_section_0_subsection_0_toggle_1_text":"field_619f2bc98677c","section_0_subsection_0_toggle_1_copy":"Good manufacturing practices (GMP) are processes or procedures that ensure products are consistently produced and controlled according to quality standards.\r\n\r\nThese procedures are designed to minimize the risks involved in any production that cannot be eliminated through testing the final product. Implementing GMP can help reduce or prevent product losses, avoid recalls, and costly lawsuits. \r\n\r\nGood manufacturing practices cover every aspect of the manufacturing process to guard against any risks that can be catastrophic for products, such as cross-contamination, adulteration, and mislabeling. \r\n\r\nTo ensure that treatments are safe and meet quality standards in cell therapy manufacturing, manufacturers must comply with good manufacturing practices (GMP) and address the following elements:\r\n
\r\n\r\n\t
Facilities (design, access and maintenance)<\/li>\r\n\r\n\t
Equipment (purchase, use and maintenance<\/li>\r\n\r\n\t
Materials (specifications, purchase, storage and use)<\/li>\r\n\r\n\t
Quality assurance (quality control, validation, qualification and document control)<\/li>\r\n<\/ul>","_section_0_subsection_0_toggle_1_copy":"field_619f2bdc8677d","section_0_subsection_0_toggle_2_tags":"","_section_0_subsection_0_toggle_2_tags":"field_619f2b808677a","section_0_subsection_0_toggle_2_category":"","_section_0_subsection_0_toggle_2_category":"field_619f2b998677b","section_0_subsection_0_toggle_2_text":"Where does the genetic material come from in gene therapy?","_section_0_subsection_0_toggle_2_text":"field_619f2bc98677c","section_0_subsection_0_toggle_2_copy":"The cells of a human being have parts called genes\u201d that control the chemical reactions in the cell that make it grow and function. \r\n\r\nGenetic material typically means DNA and RNA which are strings of molecules that help instruct cells to create proteins. \r\n\r\nDNA helps store the genetic information while RNA converts the genetic instructions contained within DNA into a format that helps cells build the correct proteins.\r\n\r\nGene therapy replaces a faulty gene or adds a new gene in an attempt to cure or improve the body\u2019s ability to fight disease. This may involve adding a wild type copy of the gene (gene addition) or altering a gene with mutation to the wild type gene (gene editing).\r\n\r\nThe transferred genetic material changes how a single protein or group of proteins is produced by the cell.","_section_0_subsection_0_toggle_2_copy":"field_619f2bdc8677d","section_0_subsection_0_toggle_3_tags":"","_section_0_subsection_0_toggle_3_tags":"field_619f2b808677a","section_0_subsection_0_toggle_3_category":"","_section_0_subsection_0_toggle_3_category":"field_619f2b998677b","section_0_subsection_0_toggle_3_text":"What is the difference between gene therapy and cell therapy?","_section_0_subsection_0_toggle_3_text":"field_619f2bc98677c","section_0_subsection_0_toggle_3_copy":"Both cell and gene therapies aim to treat, prevent, or potentially cure diseases but they work differently.\r\n\r\nThe essential difference between cell therapy and gene therapy is that cell therapy uses actual cells as the therapy, whereas gene therapy alters the genetic material of a patient in order for the patient to begin producing healthy cells themselves.\r\n\r\nA variety of different types of cells can be used in cell therapy manufacturing, including stem cells, lymphocytes, dendritic cells and pancreatic islet cells.\r\n\r\nCell therapy involves the transfer of cells with the relevant function into the patient, while gene therapy involves the transfer of genetic material, usually in a carrier or vector, and the uptake of the gene into the appropriate cells of the body.\r\n\r\nIn cell therapy, cells are modified outside the body before being infused back to the patient. . In gene therapy, genes are either replaced, inactivated or introduced into cells in order to treat a disease.\r\n\r\nIt is also possible to utilize both gene therapy and cell therapy. In this case, stem cells are isolated from the patient, genetically modified in tissue culture to express a new gene, expanded to sufficient numbers, and then returned to the patient.\r\n\r\nOne example is CAR (chimeric antigen receptor) T-cell therapy because it involves altering the genes inside T cells to help them attack the cancer before being reintroduced into the patient.\r\n\r\nCell and gene therapy can also be differentiated according to their products. Gene therapy products include plasmid DNA, viral vectors, bacterial vectors, and human gene editing technology.\r\n\r\nWhereas, cellular therapy products include cellular immunotherapies, cancer vaccines, and other types of both autologous and allogeneic cells for certain therapeutic indications.","_section_0_subsection_0_toggle_3_copy":"field_619f2bdc8677d","section_0_subsection_0_toggle_4_tags":"","_section_0_subsection_0_toggle_4_tags":"field_619f2b808677a","section_0_subsection_0_toggle_4_category":"","_section_0_subsection_0_toggle_4_category":"field_619f2b998677b","section_0_subsection_0_toggle_4_text":"How does cell and gene therapy work?","_section_0_subsection_0_toggle_4_text":"field_619f2bc98677c","section_0_subsection_0_toggle_4_copy":"To potentially cure even the most difficult diseases, gene and cell therapy manufacturing works by focusing on the building blocks of our bodies, our genes and cells.\r\n\r\nCell and gene therapy look at illnesses at a molecular level, seeking to replace damaged or dysfunctional molecules. The goal of gene and cell therapy is to develop a treatment that lasts the lifetime of the patient.\r\n\r\nCell therapy works by transferring intact, live cells into a patient to help lessen or cure a disease.\r\n\r\nWith cell therapy, cells are cultivated or modified outside the body before being injected into the patient. The cells may originate from the patient (autologous cells) or a donor (allogeneic cells).\r\n\r\nGene therapies focus on the use of genetic material to correct, replace, or stop dysfunctional genes or mutations. In some cases, gene therapy introduces new genes into the body to treat a specific disease.\r\n\r\nGene therapies can be done either inside the body (in vivo) or outside of the body (ex vivo).\r\n\r\nIn ex vivo gene therapy, cells with a genetic defect are isolated from a patient, grown in a culture, and then introduced with a therapeutic gene before being transferred back into the body.\r\n\r\nOn the other hand, in vivo gene therapy works by inserting a functioning gene into a carrier or vector (such as a non-pathogenic, non-replicating virus) which is then injected directly into the patient\u2019s bloodstream to help fight a disease.","_section_0_subsection_0_toggle_4_copy":"field_619f2bdc8677d","section_0_subsection_0_toggle":5,"_section_0_subsection_0_toggle":"field_619f2aba86779","section_0_subsection":1,"_section_0_subsection":"field_619f2a9786777","section":1,"_section":"field_619f29b986774"},"align":"wide","mode":"edit"},"attributesType":{"id":{"type":"string"},"name":{"type":"string"},"data":{"type":"object"},"align":{"type":"string"},"mode":{"type":"string"},"lock":{"type":"object"},"className":{"type":"string"}},"dynamicContent":""}]