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On-demand manufacturing of clinical-quality biopharmaceuticals.

ABSTRACT: Conventional manufacturing of protein biopharmaceuticals in centralized, large-scale, single-product facilities is not well-suited to the agile production of drugs for small patient populations or individuals. Previous solutions for small-scale manufacturing are limited in both process reproducibility and product quality, owing to their complicated means of protein expression and purification. We describe an automated, benchtop, multiproduct manufacturing system, called Integrated Scalable Cyto-Technology (InSCyT), for the end-to-end production of hundreds to thousands of doses of clinical-quality protein biologics in about 3 d. Unlike previous systems, InSCyT includes fully integrated modules for sustained production, efficient purification without the use of affinity tags, and formulation to a final dosage form of recombinant biopharmaceuticals. We demonstrate that InSCyT can accelerate process development from sequence to purified drug in 12 weeks. We used integrated design to produce human growth hormone, interferon ?-2b and granulocyte colony-stimulating factor with highly similar processes on this system and show that their purity and potency are comparable to those of marketed reference products.

SUBMITTER: Crowell LE

PROVIDER: S-EPMC6443493 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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On-demand manufacturing of clinical-quality biopharmaceuticals.

Crowell Laura E LE Lu Amos E AE Love Kerry R KR Stockdale Alan A Timmick Steven M SM Wu Di D Wang Yu Annie YA Doherty William W Bonnyman Alexandra A Vecchiarello Nicholas N Goodwine Chaz C Bradbury Lisa L Brady Joseph R JR Clark John J JJ Colant Noelle A NA Cvetkovic Aleksandar A Dalvie Neil C NC Liu Diana D Liu Yanjun Y Mascarenhas Craig A CA Matthews Catherine B CB Mozdzierz Nicholas J NJ Shah Kartik A KA Wu Shiaw-Lin SL Hancock William S WS Braatz Richard D RD Cramer Steven M SM Love J Christopher JC

Nature biotechnology 20181001

Conventional manufacturing of protein biopharmaceuticals in centralized, large-scale, single-product facilities is not well-suited to the agile production of drugs for small patient populations or individuals. Previous solutions for small-scale manufacturing are limited in both process reproducibility and product quality, owing to their complicated means of protein expression and purification. We describe an automated, benchtop, multiproduct manufacturing system, called Integrated Scalable Cyto- ...[more]

PMID: 30272677

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On-demand manufacturing of clinical-quality biopharmaceuticals.

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On-demand manufacturing of clinical-quality biopharmaceuticals.

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