An automated modular assembly line for drugs in a miniaturized plant

Chuntian Hu; Christopher J. Testa; Wei Wu; Khrystyna Shvedova; Dongying Erin Shen; Ridade Sayin; Bhakti S. Halkude; Federica Casati; Paul Hermant; Anjana Ramnath; Stephen C. Born; Bayan Takizawa; Thomas F. O’Connor; Xiaochuan Yang; Sukumar Ramanujam; Salvatore Mascia

doi:10.1039/C9CC06945C

An automated modular assembly line for drugs in a miniaturized plant†‡

Chuntian Hu,

§*^a Christopher J. Testa,

§^a Wei Wu,^a Khrystyna Shvedova,^a Dongying Erin Shen,^a Ridade Sayin,^a Bhakti S. Halkude,^a Federica Casati,^ab Paul Hermant,^a Anjana Ramnath,^a Stephen C. Born,^a Bayan Takizawa,^a Thomas F. O’Connor,^c Xiaochuan Yang,

^c Sukumar Ramanujam^d and Salvatore Mascia

*^a

Author affiliations

* Corresponding authors

^a CONTINUUS Pharmaceuticals, 25R Olympia Ave, Woburn, MA, USA
E-mail: chu@continuuspharma.com, smascia@continuuspharma.com

^b IMA S.p.a., Via I Maggio 14-16, Ozzana dell’Emilia, Bologna, Italy

^c Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, USA

^d USV Private Limited, Arvind Vithal Gandhi Chowk, BSD Marg, Station Road, Govandi East, Mumbai, India

Abstract

We report here a fully automated, end-to-end, integrated continuous manufacturing process for a small-molecule generic medication with built-in quality assurance. The entire process fits into a box of 30.7 m² modular footprint and a total residence time of less than 30 h, with a throughput up to 40.3 × 10⁶ tablets per year.

Chemical Communications

An automated modular assembly line for drugs in a miniaturized plant†‡

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