• The growth of cell and gene therapies signals disruption for the entire healthcare ecosystem, requiring new thinking around development, administration, value, and We are uniquely positioned to help you. Develop a strategic GMP manufacturing plan that reduces complexity, time and risk.
  • Experience with cell-based potency assays for AAV and other viral vectors. With years of experience in biosafety assessment, Our QVirus™ Platform can design a customized testing program to assess the purity, potency, and safety of your viral vaccine or gene therapy product at phase-appropriate levels to support your regulatory filing.
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  • Cellular respiration is a metabolic pathway that breaks down glucose and produces ATP. The stages of cellular respiration include glycolysis, pyruvate oxidation, the citric acid or Krebs cycle, and oxidative phosphorylation.
  • Gene therapy is effective in patients with X-linked SCID, 12 but its use has been hampered by the development of T-cell leukemia due to insertional mutagenesis caused by the retroviral vector. 13 ...
  • This randomized phase II trial studies how well giving vaccine therapy with or without bevacizumab works in treating patients with recurrent glioblastoma multiforme that can be removed by surgery. Vaccines consisting of heat shock protein-peptide complexes made from a person's own tumor tissue may help the body build an effective immune ...
Since 1992, MDS has been providing comprehensive services for Release Package [GMP Support], evaluating cell banks, raw materials and cell derivatives such as monoclonal antibodies, recombinant proteins, vaccines and gene therapy products for our national and international clients.
The goal of the Program in Human Gene Therapy is to develop gene transfer technologies and use them for hepatic gene therapy for the treatment of genetic and acquired diseases. The general approach is to develop new vector systems and delivery methods, test them in the appropriate animal models, uncover the mechanisms involved in vector ...
For years, the foundations of cancer treatment were surgery, chemotherapy, and radiation therapy. Over the last two decades, targeted therapies like imatinib (Gleevec®) and trastuzumab (Herceptin®) —drugs that target cancer cells by homing in on specific molecular changes seen primarily in those cells—have also cemented themselves as standard treatments for many cancers. GMP Cell-based Assays or Potency Assay Applications We apply phase-appropriate potency testing to wide array of biologic products including biosimilars , peptides, monoclonal antibodies , growth factors and cytokines and applications, such as biopharmaceutical stability testing and biologic drug product release testing .
The French biotech GenSight Biologics has received regulatory authorization in the UK to launch the PIONEER Phase 1 \ 2 clinical trial for its GS030 system — a light-sensing gene therapy (optogenetics) coupled with eyewear, which enhances visual stimulation.
Gene and cell therapy have significant potential in treating a variety of diseases - from cancer to genetic disorders. In vitro, T cells can be reprogrammed to identify specific antigenic targets on cancerous B cells in vivo. Gene therapy efficacy also depends on successful binding of transfer...Sep 15, 2020 · A high level of regulatory support, and appropriate documentation packets facilitates the progress of a new therapy towards commercial use. Cell and gene therapies are inherently patient-centric, and therefore might require some adjustment of suppliers to ensure they are fully supported. Regional manufacturing enhances the continuous supply of ...
Aug 29, 2012 · Development of meaningful and relevant potency assays for cell therapy products necessitates extensive product characterization. Measures of potency may be demonstrated using in vitro and/or in vivo tests, as appropriate. This topic is discussed in detail in FDA’s guidance on potency tests for cell and gene therapy products . Our platform plasmid manufacturing process yields up to multi-gram quantities of clinical grade plasmid DNA that can be used for direct injection as DNA vaccines, gene therapy, or ex-vivo applications such as cell and gene therapies. Waisman has delivered plasmid DNA vaccines for Phase 1/2 clinical trials and can support Phase 3/commercial for plasmid DNA used as an ancillary material.

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