Therapy for the individual: Towards patient integration into the manufacturing and provision of pharmaceuticals

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Govender, Rydvikha,1989AstraZeneca AB,Chalmers tekniska högskola,Chalmers University of Technology (författare)

Therapy for the individual: Towards patient integration into the manufacturing and provision of pharmaceuticals

Artikel/kapitelEngelska2020

Förlag, utgivningsår, omfång ...

Elsevier BV,2020

Nummerbeteckningar

LIBRIS-ID:oai:research.chalmers.se:d3ff909a-270b-4fa7-b7ee-e239ac655679
https://research.chalmers.se/publication/515691URI
https://doi.org/10.1016/j.ejpb.2020.01.001DOI

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Språk:engelska
Sammanfattning på:engelska

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Anmärkningar

Individualized therapy with pharmaceutical products aims to elicit predictable and optimized treatment responses from specific patients. Doing so requires production platforms and technology capable of tailoring products to individual patient needs. However, despite recent manufacturing innovations and key technologies on the rise, e.g. continuous manufacturing and additive manufacturing (3D printing), the prevailing production paradigm employed in the pharmaceutical industry is mass production. Although mass production is efficient and cost-effective, it is typically based on a ‘one-size-fits-all’ product concept and lacks the flexibility and agility required to fully meet the needs of the individual patient. Indeed, we present data that confirm a suspected major imbalance between the recent medical evolution underpinning personalized/precision medicine and the recent advances in the associated manufacturing technologies. In this context we target the needs of the individual as a main driver for pharmaceutical products which support individualized therapy. We particularly address that a wider integration of critical patient dimensions into the manufacture and provision of pharmaceutical products is pivotal for enabling a patient-centric and efficient mass customization-based production paradigm. Here, we present a critical review of the area and its inherent challenges which aims to clarify key design requirements for establishing mass customization opportunities. Through primary sources of scientific information for individualized therapies, patient needs are captured, analysed, and conceptualized. This summarized set of key drivers provides the basis for a proposed patient-centric framework of requirements for use in design of product and production platforms for mass customization. The extent to which emerging pharmaceutical manufacturing technologies satisfy key individual patient needs is explored through a high-level assessment against the proposed patient-centric framework, with special attention paid to oral dosage forms. Altogether this holistic review and position paper, with its constituent steps, reveals major gaps in the evolution of Product-Process-Production approaches and solutions required for producing affordable individualized/personalized pharmaceuticals that respond to the needs and demands of the individual patient. Lastly, in a brief commentary and outlook, we suggest key research directions for closing gaps and addressing manufacturing technology challenges. We also articulate the importance of tackling them in a holistic, integrated way, together with challenges in product individualization and personalization.

Ämnesord och genrebeteckningar

TEKNIK OCH TEKNOLOGIER Maskinteknik Produktionsteknik, arbetsvetenskap och ergonomi hsv//swe
ENGINEERING AND TECHNOLOGY Mechanical Engineering Production Engineering, Human Work Science and Ergonomics hsv//eng
TEKNIK OCH TEKNOLOGIER Maskinteknik Annan maskinteknik hsv//swe
ENGINEERING AND TECHNOLOGY Mechanical Engineering Other Mechanical Engineering hsv//eng
TEKNIK OCH TEKNOLOGIER Annan teknik Övrig annan teknik hsv//swe
ENGINEERING AND TECHNOLOGY Other Engineering and Technologies Other Engineering and Technologies not elsewhere specified hsv//eng
Mass customization
Pharmaceutical manufacturing
Design requirements
Patient-centric drug product
Technology suitability
Personalized medicine

Biuppslag (personer, institutioner, konferenser, titlar ...)

Abrahmsén-Alami, SusannaAstraZeneca AB (författare)
Larsson, Anette,1966Chalmers tekniska högskola,Chalmers University of Technology(Swepub:cth)anettel (författare)
Folestad, StaffanAstraZeneca AB (författare)
AstraZeneca ABChalmers tekniska högskola (creator_code:org_t)

Sammanhörande titlar

Ingår i:European Journal of Pharmaceutics and Biopharmaceutics: Elsevier BV149, s. 58-761873-34410939-6411

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European Journal of Pharmaceutics and Biopharmaceutics (Sök värdpublikationen i LIBRIS)

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Av författaren/redakt...: Govender, Rydvik ...; Abrahmsén-Alami, ...; Larsson, Anette, ...; Folestad, Staffa ...

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TEKNIK OCH TEKNOLOGIER: TEKNIK OCH TEKNO ...; och Maskinteknik; och Produktionstekni ...

TEKNIK OCH TEKNOLOGIER: TEKNIK OCH TEKNO ...; och Maskinteknik; och Annan maskintekn ...

TEKNIK OCH TEKNOLOGIER: TEKNIK OCH TEKNO ...; och Annan teknik; och Övrig annan tekn ...

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Av lärosätet: Chalmers tekniska högskola

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