Projects selected for the Process Innovation Award have applied novel process manufacturing techniques on existing or new facilities including fundamental scientific processing approaches and related applied science-based solutions to existing and new challenges.
Project: Mirror 1: A Continuous Manufacturing Platform
Janssen’s Mirror 1 Continuous Manufacturing Platform project represents a significant step in process innovation that allows Janssen to effectively execute a continuous manufacturing control strategy.
FOYA Judges
Janssen Pharmaceutical Companies of Johnson & Johnson focuses on areas of medicine where they can make the biggest difference including oncology, infectious diseases and vaccines, cardiovascular and metabolism, immunology, neuroscience, and pulmonary hypertension. Janssen’s more than 40,000 employees worldwide are working to create a future where disease is a thing of the past by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart.
Until recently Janssen developed and manufactured all tablet formulations in a multi-purpose batch facility. However, as the company formulated a mission that focused on making the patient the center of all decisions, improving quality, reliability, and control, and reducing development and scale up cycle times, they found that the batch platform did not support their vision. Janssen decided they had to completely change strategy in order to support their new mission and embarked upon an end-to-end (E2E) strategy that included investing in continuous manufacturing (CM) as their preferred technology platform for all future oral solid dosage formulations. To support their new E2E strategy and commitment to CM, Janssen designed, installed, and qualified a new CM line, Mirror 1, at their Drug Product Pilot plant in Beerse, Belgium.
The Mirror line incorporates wet granulation, dry granulation, and tablet compression. Additionally, the pioneering Mirror concept:
Reduces API-needs, which will reduce costs
Produces consistent product quality throughout development and scale-out/transfer, which can minimize unexpected issues
Reduces the number of clinical bioavailability and bioequivalence trials, again reducing cost
Improves tailoring of supply versus demand
Enables further scientific strengthening of new drug product submissions
” The unique advantages of introducing an E2E platform also used in the R&D stages gives an additional potential to support the development of more products which would otherwise not be possible, thereby supporting the introduction of new and improved drugs on the market,” said Luca Russo, Global Head, Clinical Supply Chain, Janssen.
ISPE congratulates Janssen on the success of the Mirror 1 Line at their plant in Beerse, Belgium, for their achievements in advancing research and development and for their FOYA award winning entry for Process Innovation. Learn more about the 2020 FOYA Process Innovation winner.
Has your company recently designed, built or renovated a state-of-the-art pharmaceutical or biotechnology facility that is best in its class?
ISPE is now accepting entries into the 2021 ISPE Facility of the Year Awards (FOYA) Program, and your facility may be eligible to apply. Learn more about the Facility of the Year Awards submission process and your company could be the next Facility of the Year Awards Category winner. Nominate your facility in 2021
Want to learn more about the 2020 FOYA winning projects? Get inspiration for future innovations at these complimentary digital events.
Get a free Facility of the Year Awards Day Pass to take an in-depth look at each of the 2020 FOYA winning projects during the 2020 ISPE Annual Meeting & Expo. Claim your complimentary pass today to benefit from 3 hours of compelling and insightful sessions.
Join ISPE and prominent industry leaders on Tuesday, 3 November, as we come together to recognize the outstanding achievements of all the FOYA winners during the 2020 Facility of the Year Awards Virtual Banquet.
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