Abstract：
:DNA plasmid-based gene expression systems are being widely investigated for the potential treatment of genetic and acquired disease and for DNA-based vaccination. A number of human clinical trials are in progress using plasmid-based drugs. The regulatory framework that has been applied to biologicals such as recombinant DNA-derived proteins has proven to be generally applicable for regulating plasmid-based drugs as well. This was recently emphasized by the inclusion of therapeutic DNA plasmid products in the U.S. Food and Drug Administration's list of well-characterized biotechnology products. Present techniques for manufacturing and characterizing plasmids have been adapted from large-scale protein purification and from traditional molecular biology. Production of multi-gram quantities of plasmid, at purities of 95% or more, is currently possible, but further development of both manufacturing and analytical techniques is required. This review describes the approaches and methods currently used to manufacture and characterize DNA plasmids for pharmaceutical use, as well as recent changes in the regulatory environment that will impact future development and marketing of plasmids as human drugs.
journal_name
Adv Drug Deliv Revjournal_title
Advanced drug delivery reviewsauthors
Eastman EM,Durland RHdoi
10.1016/s0169-409x(97)00105-1subject
Has Abstractpub_date
1998-03-02 00:00:00pages
33-48issue
1-3eissn
0169-409Xissn
1872-8294pii
S0169-409X(97)00105-1journal_volume
30pub_type
杂志文章abstract：:Basic science advances in bone tissue engineering using osteoinductive protein therapy have already been translated to the use in patients with selected orthopedic problems. The story of the development of bone morphogenetic protein (BMP) osteoinductive therapy, from the discovery of this class of molecules in 1965 to...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2006.03.009
更新日期：2006-07-07 00:00:00
abstract：:Clinical development of orally active peptide drugs has been restricted by their unfavorable physicochemical properties, which limit their intestinal mucosal permeation and their lack of stability against enzymatic degradation. Successful oral delivery of peptides will depend, therefore, on strategies designed to alte...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章
doi：10.1016/s0169-409x(97)00045-8
更新日期：1997-09-15 00:00:00
abstract：:Ruminants have a specialised digestive system that contains anaerobic bacteria and protozoa capable of digesting the cellulosic materials that are so common in plant materials. In addition, their distinct digestive system can change the metabolism and mode of action of some nutrients, medicines or other bioactive mate...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2004.02.011
更新日期：2004-06-23 00:00:00
abstract：:Analogues of luteinizing hormone-releasing hormone (LH-RH) have made possible new approaches to the treatment of some hormone-dependent cancers and diseases and conditions which result from inappropriate sex hormone levels. In the fields of both gynaecology and oncology, the development of sustained delivery depot sys...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章
doi：10.1016/s0169-409x(97)00056-2
更新日期：1997-10-13 00:00:00
abstract：:Theranostic systems support diagnostic and therapeutic functions in a single integrated entity and enable precise spatiotemporal control of the generation of therapeutic molecules according to the individual patient's disease state, thereby maximizing the therapeutic outcome and minimizing side effects. These systems ...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2016.05.006
更新日期：2016-10-01 00:00:00
abstract：:Amphotericin B colloidal dispersion (ABCD) is a near 1:1 discoidal complex of amphotericin B (AMB) and sodium cholesteryl sulfate (SCS) arranged as a bilayer of SCS interspersed with AMB via noncovalent interactions. The complex is stable in blood and plasma with minimal dissociation. In vitro and in vivo studies show...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/s0169-409x(01)00104-1
更新日期：2001-04-25 00:00:00
abstract：:Whereas in vivo studies represent the most crucial test for any nasal drug application or formulation, mechanistic aspects of nasal absorption may be more clearly approached by well defined and controlled in vitro studies. In this review the progress of nasal in vitro models to investigate drug permeation and metaboli...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章
doi：10.1016/s0169-409x(97)00061-6
更新日期：1998-01-05 00:00:00
abstract：:Responsive hydrophobically associating polymers can in many ways be considered to be analogous to proteins in their ability to form compact molecules with a defined secondary structure, and hence, functionality. These molecules are characterized by the presence of alternating charged and hydrophobic groups. The balanc...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/s0169-409x(01)00223-x
更新日期：2001-12-03 00:00:00
abstract：:The use of in silico tools within the drug development process to predict a wide range of properties including absorption, distribution, metabolism, elimination and toxicity has become increasingly important due to changes in legislation and both ethical and economic drivers to reduce animal testing. Whilst in silico ...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章
doi：10.1016/j.addr.2015.03.005
更新日期：2015-06-23 00:00:00
abstract：:Tendon injuries represent a significant clinical burden on healthcare systems worldwide. As the human population ages and the life expectancy increases, tendon injuries will become more prevalent, especially among young individuals with long life ahead of them. Advancements in engineering, chemistry and biology have m...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2014.11.022
更新日期：2015-04-01 00:00:00
abstract：:The mammalian immune system has evolved mechanisms to recognize and respond to 'danger' signals arising from pathogens. Among those danger signals are the unmethylated CpG dinucleotide motifs found in bacteria. At least some of the recognition of these sequences is through cellular components of the innate immune syst...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/s0169-409x(00)00090-9
更新日期：2000-11-15 00:00:00
abstract：:Bioprinted skin tissue has the potential for aiding drug screening, formulation development, clinical transplantation, chemical and cosmetic testing, as well as basic research. Limitations of conventional skin tissue engineering approaches have driven the development of biomimetic skin equivalent via 3D bioprinting. A...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2018.07.016
更新日期：2018-07-01 00:00:00
abstract：:The administration of radiolabeled compounds with gamma-emitting radionuclides allows real time pursuit of in vivo behavior of the compounds by external counting of the radioactivity. If the compounds possess a specific localization mechanism to target tissue, the image reflects the specific function of the target. Th...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章
doi：10.1016/s0169-409x(98)00102-1
更新日期：1999-04-05 00:00:00
abstract：:The description of irregular particle morphology and powder properties may offer unique insights into the performance of materials intended for use in dry powder inhalers. A number of mathematically similar approaches have been used to study these phenomena, all based on evaluating data in terms of irregular oscillati...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章
doi：10.1016/s0169-409x(97)00508-5
更新日期：1997-06-09 00:00:00
abstract：:The incorporation of polymer-lipid conjugates, initially using PEG and subsequently other selected flexible, hydrophilic polymers, into lipid bilayers gives rise to sterically stabilized liposomes that exhibit reduced blood clearance and concomitant changes in tissue distribution largely because of reduced, but not el...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章
doi：10.1016/s0169-409x(97)00136-1
更新日期：1998-06-08 00:00:00
abstract：:PEGylation is a clinically proven strategy for increasing the therapeutic efficacy of protein-based medicines. Our approach to site-specific PEGylation exploits the thiol selective chemistry of the two cysteine sulfur atoms from an accessible disulfide. It involves two key steps: (1) disulfide reduction to release the...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2007.06.014
更新日期：2008-01-03 00:00:00
abstract：:Novel materials are often commercialized without a complete assessment of the risks they pose to human health because such assessments are costly and time-consuming; additionally, sometimes the methodology needed for such an assessment does not exist. Carbon nanotubes have the potential for widespread application in e...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2013.05.011
更新日期：2013-12-01 00:00:00
abstract：:Drug-device combination products introduced a new dynamic on medical product development, regulatory approval, and corporate interaction that provide valuable lessons for the development of new generations of combination products. This paper examines the case studies of drug-eluting stents and transdermal patches to f...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2011.10.008
更新日期：2012-01-01 00:00:00
abstract：:The encapsulation of liquids and semi-solids provides solutions for convenient delivery through improved oral absorption of poorly water-soluble drugs. In addition, low dose (content uniformity), highly potent (containment), low melting point drugs, those with a critical stability profile and those for which a delayed...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2007.09.009
更新日期：2008-03-17 00:00:00
abstract：:Mesenchymal stem cells (MSCs) have been developed for a number of indications due to their regenerative and anti-inflammatory phenotypes and their utility is enhanced by the fact that allogeneic transplant is feasible with this cell type. Animal studies and early human cases indicate that this has the potential to be ...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2017.10.003
更新日期：2018-01-01 00:00:00
abstract：:Human genome sequencing revealed that only ~1.5% of the DNA sequence coded for proteins. More and more evidence has uncovered that a substantial part of the 98.5% so-called "junk" DNAs actually code for noncoding RNAs. Two milestones, chemical drugs and protein drugs, have already appeared in the history of drug devel...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2013.11.006
更新日期：2014-02-01 00:00:00
abstract：:Safe and effective hemoglobin-based blood substitutes may be advantageous over conventional therapies for certain clinical settings requiring short term blood replacement such as emergency resuscitation and hemodilution in surgery. Many advances have been made in developing these oxygen therapeutics, however safety co...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/s0169-409x(99)00050-2
更新日期：2000-02-28 00:00:00
abstract：:Cell surface receptors play a central role in the regulation of both cellular and systemic physiology by mediating intercellular communication, facilitating protein trafficking, and regulating virtually all intracellular processes. Receptor expression is often cell specific and is determined by cellular lineage, genet...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章
doi：10.1016/s0169-409x(97)00079-3
更新日期：1998-02-02 00:00:00
abstract：:The coiled-coil is a ubiquitous protein folding and assembly motif made of alpha-helices wrapping around each other forming a supercoil. The sequences of coiled-coils are made of seven-residue repeats, called heptads, and thus are polymer-like. Due to its simplicity and regularity, the coiled-coil is the most extensiv...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/s0169-409x(02)00058-3
更新日期：2002-10-18 00:00:00
abstract：:A polymer stereocomplex is defined as a stereoselective interaction between two complementing stereoregular polymers, that interlock and form a new composite, demonstrating altered physical properties in comparison to the parent polymers. The main interactions, resulting in the complexation, are suggested to rely on s...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/s0169-409x(03)00042-5
更新日期：2003-04-25 00:00:00
abstract：:Peptide nucleic acid (PNA) is a DNA mimic having a pseudopeptide backbone that makes it extremely stable in biological fluids. PNA binds complementary RNA and DNA with high affinity and specificity. These qualities make PNA a leading agent among "third generation" antisense and antigene agents. Unfortunately, fast pro...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/s0169-409x(02)00182-5
更新日期：2003-02-10 00:00:00
abstract：:Numerous drugs are known to deplete mitochondrial DNA (mtDNA) from mammalian cells. These include DNA polymerase gamma and type II topoisomerase inhibitors, lipophilic cationic compounds, and DNA intercalating and non intercalating agents. The effects of these drugs on mtDNA metabolism will be discussed and potential ...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/s0169-409x(01)00133-8
更新日期：2001-07-02 00:00:00
abstract：:Silicon is one of the most abundant chemical elements found on the Earth. Due to its unique chemical and physical properties, silicon based materials and their oxides (e.g. silica) have been used in several industries such as building and construction, electronics, food industry, consumer products and biomedical engin...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2012.05.008
更新日期：2012-12-01 00:00:00
abstract：:In the past 15years, despite that regenerative medicine has shown great potential for cardiovascular diseases, the outcome and safety of stem cell transplantation has shown controversial results in the published literature. Medical imaging might be useful for monitoring and quantifying transplanted cells within the he...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章,评审
doi：10.1016/j.addr.2017.07.012
更新日期：2017-10-01 00:00:00
abstract：:To guard against disease, mucosal surfaces of the intestinal, respiratory and urogenital tracts are protected by a carefully regulated system of defenses known as the mucosal immune system. The hallmark of mucosal immunity is secretory IgA which can prevent infection and remove antigen crossing the mucosal barrier. Ig...
journal_title：Advanced drug delivery reviews
pub_type： 杂志文章
doi：10.1016/s0169-409x(98)00042-8
更新日期：1998-12-01 00:00:00
