Clinical development of therapeutic recombinant proteins
نویسندگان
چکیده
منابع مشابه
Clinical development of therapeutic recombinant proteins.
Only a small subset of the therapeutics that enter clinical studies will prove to be safe and effective in humans and gain approval for marketing. The success of the products and, by inference, the sponsoring companies can be measured by tracking advancement through the clinical phase and review transitions to marketing approval. To determine phase transition probabilities and approval success ...
متن کاملQuality Control of Widely Used Therapeutic Recombinant Proteins by a Novel Real-Time PCR Approac
Background: Existence of bacterial host cell DNA contamination in biopharmaceutical products is a potential risk factor for patients receiving these drugs. Hence, the quantity of contamination must be controlled under the regulatory standards. Although different methods such as hybridization assays have been employed to determine DNA impurities, these methods are labor, intensive and rather exp...
متن کاملAdvanced analytical strategies for recombinant therapeutic proteins.
Therapeutic proteins produced using recombinant DNA technologies are generally complex, heterogeneous, and subject to a variety of enzymatic or chemical modifications during expression, purification, and long-term storage. Hence the analytical strategies for characterization, quantitation, purity assay and evaluation of the biological activity of recombinant proteins still represent a big chall...
متن کاملRecombinant therapeutic proteins: production platforms and challenges.
Since the approval of insulin in 1982, more than 120 recombinant drug substances have been approved and become available as extremely valuable therapeutic options. Exact copying of the most common human form is no longer a value per se, as challenges, primarily related to the pharmacokinetics of artificial recombinant drugs, can be overcome by diverging from the original. However, relatively mi...
متن کاملUtility of P19 Gene-Silencing Suppressor for High Level Expression of Recombinant Human Therapeutic Proteins in Plant Cells
Background: The potential of plants, as a safe and eukaryotic system, is considered in the production of recombinant therapeutic human protein today; but the expression level of heterologous proteins is limited by the post-transcriptional gene silencing (PTGS) response in this new technology. The use of viral suppressors of gene silencing can prevent PTGS and improve transient expression level ...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: BioTechniques
سال: 2003
ISSN: 0736-6205,1940-9818
DOI: 10.2144/03351dd01