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Toxicology and Biodistribution: The Clinical Value of Animal Biodistribution Studies
Beatriz Silva Lima, Mafalda Ascensão Videira Molecular Therapy - Methods & Clinical Development Volume 8, Pages (March 2018) DOI: /j.omtm Copyright © 2018 The Authors Terms and Conditions
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Figure 1 Risk Profiling for ATMPs following the Risk-Based Approach
Molecular Therapy - Methods & Clinical Development 2018 8, DOI: ( /j.omtm ) Copyright © 2018 The Authors Terms and Conditions
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Figure 2 AAV1 Capsid Diagram Structure of Alipogene Tiparvovec
Extracted from European Public Assessment Report: Glybera (alipogene tiparvovec). EMEA/H/C/ (2012).14 Molecular Therapy - Methods & Clinical Development 2018 8, DOI: ( /j.omtm ) Copyright © 2018 The Authors Terms and Conditions
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Figure 3 Talimogene Laherparepvec Has Been Modified to Replicate within Tumors and to Produce the Immune Stimulatory Protein Human GM-CSF The schematic diagram illustrates the mechanism from which T-VEC was developed. Basically, herpes simplex 1 virus render the modified vector known as talimogene laherparepvec (T-VEC) by deletion of ICP34.5 and ICP47 and posterior insertion of the coding sequence GM-CSF. The genome is composed of a unique long (UL region) flanked by long repeats (RL) and a unique short region (US) flanked by short repeats (RS). The site of the human GM-CSF cassette insertion is expanded to show the composition; the CMV (cytomegalovirus) promoter, human GM-CSF cDNA, and a (polyadenylation) pA signal. Adapted from lmlygic EPAR, EMA/734400/2015 ( Molecular Therapy - Methods & Clinical Development 2018 8, DOI: ( /j.omtm ) Copyright © 2018 The Authors Terms and Conditions
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Figure 4 Proposed Mechanism of Action for Talimogene Laherparepvec
Extracted from lmlygic EPAR, EMA/734400/2015. Molecular Therapy - Methods & Clinical Development 2018 8, DOI: ( /j.omtm ) Copyright © 2018 The Authors Terms and Conditions
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