Polyamino Acid Carriers In Drug Delivery And Their Production Under Good Manufacturing Practice Compliance
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Polyamino Acid Carriers In Drug Delivery And Their Production Under Good Manufacturing Practice Compliance

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Polyamino Acid Carriers In Drug Delivery And Their Production Under Good Manufacturing Practice Compliance

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dc.contributor.advisor Nebot Carda, Vicent Josep
dc.contributor.advisor Vicent Docón, María Jesús
dc.contributor.author Morelló Bolumar, Daniel
dc.contributor.other Facultat de Química es_ES
dc.date.accessioned 2021-06-21T08:53:39Z
dc.date.available 2022-06-22T04:45:05Z
dc.date.issued 2021 es_ES
dc.date.submitted 21-06-2021 es_ES
dc.identifier.uri https://hdl.handle.net/10550/79781
dc.description.abstract Poly(Amino Acids) (PAA)s are biocompatible, biodegradable and multifunctional polymers, which have been effectively used as building blocks in polymer-based delivery carriers for various medical applications. In addition, PAAs are envisaged to achieve a major impact on biomedical areas due to their structural versatility, biocompatibility, water-solubility and the important advances made on the synthetic strategies. Control on polymer chain length and stereochemistry have been one of the major challenges in PAA synthesis over the past years. Their physico-chemical properties can be modulated in terms of the manufacturing process, size, electrostatic charge, conformation, geometry, topology, monomer composition. Also, the structural elements such as the Active Pharmaceutical Ingredient (API) nature, the API-carrier interaction and the supramolecular architecture of the drug delivery system (micelle, vesicle, polymer-drug conjugate, polyplex, hydrogel, or nanoparticle) can be designed and controlled. Within the current state of the art of PAA-based materials, the vast majority of compounds are in the early stages of R&D or Proof of Concept (POC) with few examples of PAA-based therapeutics in clinical trials or marketed. The process to move a candidate from R&D to the market is a long travel that must be performed under the Good Manufacturing Practice (GMP) regulation. And inside of this GMP regulation, the Chemistry Manufacturing and Control (CMC) activities must be applied to support, control, and secure the travel. The CMC activities encompass the development, optimization, and performance of the manufacturing process and the analytical methodologies, as well as quality management systems, quality grade definition, facilities, equipment, laboratory controls, materials, packaging, labeling, and even shipment. Moreover, the quality management systems of CMC activities also contain the deviation identification, investigation, and risk management of the manufacturing process, and also the analytical methodologies qualification and validation. es_ES
dc.format.extent 244 es_ES
dc.language.iso en_US es_ES
dc.subject polyamino acid es_ES
dc.subject good manufacturing practice es_ES
dc.title Polyamino Acid Carriers In Drug Delivery And Their Production Under Good Manufacturing Practice Compliance es_ES
dc.type info:eu-repo/semantics/doctoralThesis es_ES
dc.subject.unesco UNESCO::QUÍMICA es_ES
dc.embargo.terms 1 year es_ES

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