Cell Therapies vaccine

CeUular Therapies. Since 1984 CBER has reviewed close to 300 somatic cell therapy protocols. Examples of the specific categories include manipulation, selection, mobilization, tumor vaccines and other. 

Another cell therapy method includes the excision of cells from the body. These cells are then modified and returned to the host body. Provenge, a cancer vaccine using cell therapy, has completed Phase III trial and is being reviewed by the FDA. The technique for this therapy is given in Exhibit 4.17. 

Provenge is a cancer vaccine using cell therapy technique. Dendritic cells are removed from patients. These cells are treated with the prostate-specific antigen prostatic acid phosphatase (PAP), which is present in 95% of prostate cancer cases. The activated dendritic cells are returned to the patients and they stimulate the T cells to destroy cancer cells expressing the PAP, thus treating the tumor. 

Walsh (2003) defined biopharmaceuticals as therapeutic protein or nucleic acid preparations made by techniques involving recombinant deoxyribonucleic acid (DNA) technology. Therapeutic proteins include blood clotting factors and plasminogen activators, hemopoietic factors, hormones, interferons and interleukins, and monoclonal antibodies (LeVine, 2006). Over time, the term biopharmaceutical has broadened, and, in addition to proteins and nucleic acids, now includes bacteriophages, viral and bacterial vaccines, vectors for gene therapy, and cells for cell therapy (Primrose and Twyman, 2004). Attention here focuses on proteins, since the majority of approved biopharmaceuticals are proteins. 

Cell-based vaccines EMEA points to consider on the manufacture and quality control of human somatic cell therapy medicinal products 2001... 

Viral vector and cell-based vaccines FDA guidance for industry guidance for human somatic cell therapy and gene therapy 1998... 

Here, an overview of biopharmaceutical products thus far approved (within the EU and US at least) is presented. The products have been grouped into nine categories recombinant blood factors, recombinant thrombolytics, recombinant insulins, additional recombinant hormones, recombinant hematopoietic growth factors, recombinant IFNs and ILs, recombinant vaccines, monoclonal and engineered antibodies, and additional biopharmaceuticals (e.g., cell therapy, gene therapy, siRNA). 

Vaccination would be a welcome option to manage H. pylori infection and could overcome drawbacks of the current antibiotic therapy and prevent reinfection. The feasibility of vaccination has originally been demonstrated in mice immunized with a whole cell derived vaccine which were protected from a challenge with H. felis (Chen et al,... 

Reinhard G, Marten A, Kiske SM, Feil F, Bieber T, Schmidt-Wolf IG. Generation of dendritic cell-based vaccines for cancer therapy. Br J Cancer 2002 86 1529-1533. 

The development of effective models of animal disease of HCV to evaluate potential therapeutic agents is very complex due to the extremely narrow species trophism. While the reasons behind the species trophism are not completely understood, nearly all the HBV- or HCV-permissive rodent models require xenografting of human hepatocytes and a permanent lack of rejection of these engrafted cells. A detailed discussion of the various types of rodent models utilized in understanding the pathogenesis of HBV/HCV and potential for therapy/vaccine development is beyond the scope of this chapter and can be found in recent reviews (Liu etal., 2013). 

Biological medicines cannot be adequately characterized by physical or chemical means alone. They include bacterial and viral vaccines, blood and serum products, and other immunological, endocrinological, and cell-based medicines. Biologicals play a significant role in medicine and public health, as well as featuring in transplantation and cell therapy programs. 

Future cultivation methods will resemble existing methods of microbial and virus culture. Ill-defined medium components and cells will be replaced to enhance reproducibflity in production. For bacterial and ex vivo cultivated virus, analytical advances will make monitoring the environment and nutritional status of the culture more ubiquitous. However, the major changes will be in novel product types — single-molecule subunit antigens, viras-hke particles, monoclonal antibodies, and gene-therapy vaccines, each of which will incorporate novel processes. 

Shatma S, Miller P, Stolina M, et al. Multi-component gene therapy vaccines for lung cancer effective eradication of established murine tumors in vivo with interleukin 7/herpes simplex thymidine kinase-transduced autologous tumor and ex vivo-activated dendritic cells. Gene Ther 1997 4 1361-1370. 

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