The Future of Pharmaceutical Manufacturing Sciences

Abstract

The entire pharmaceutical sector is in an urgent need of both innovative technological solutions and fundamental scientific work, enabling the production of highly engineered drug products. Commercial‐scale manufacturing of complex drug delivery systems (DDSs) using the existing technologies is challenging. This review covers important elements of manufacturing sciences, beginning with risk management strategies and design of experiments (DoE) techniques. Experimental techniques should, where possible, be supported by computational approaches. With that regard, state‐of‐art mechanistic process modeling techniques are described in detail. Implementation of materials science tools paves the way to molecular‐based processing of future DDSs. A snapshot of some of the existing tools is presented. Additionally, general engineering principles are discussed covering process measurement and process control solutions. Last part of the review addresses future manufacturing solutions, covering continuous processing and, specifically, hot‐melt processing and printing‐based technologies. Finally, challenges related to implementing these technologies as a part of future health care systems are discussed. © 2015 The Authors. Journal of Pharmaceutical Sciences published by Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:3612–3638, 2015

Reconfiguring global pharmaceutical value networks through targeted technology interventions

“…For many decades, the drug product manufacturing model has been controlled by a regulatory framework -safeguarding the quality of the final product, by stringent process monitoring, testing of raw material, in-process material and endproduct characteristics -using batch-based operations (Rantanen and Khinast 2015;. However, the sector needs to become more responsive to a changing environment, to devise new ways of providing patients with improved health 'outcomes', at a fraction of today's cost (Erhard et al 2013).…”

“…The sector has a reputation for being conservative, compared to other related industries that have successfully implemented sophisticated advanced manufacturing technologies (AMTs) that increase both process and product understanding (Saberi and Yusuff 2012;Rantanen and Khinast 2015). While identification, selection, acquisition and implementation issues have been dominant topics to-date in AMT literature (Chan et al 2001;Goyal and Grover 2012), currents trends across the pharmaceutical industry -in accelerating innovative technology delivery, and establishing new supply chains for medicines -can help address a key research gap of addressing the realities of modern manufacturing environments (Farooq and O'Brien 2012).…”

Digitalisation of Development and Supply Networks: Sequential and Platform-Driven Innovations

“…Moderating practices in the pharmaceutical sector are often seen as 'ultra-conservative' and 'old school' compared to other industries that routinely implement sophisticated technologies to increase both process and product understanding and implementation (Rantanen and Khinast, 2015). As shown in sections 5.1 and 5.2, this 'slow' route of 'incrementalism' associated with sequential pathways is driven by entities avoiding operational tasks burdened with risk in 'transitioning'.…”

Quality by design (QbD) and process analytical technology (PAT) applications in pharmaceutical industry

“…Guidelines such as ICH Q8, ICH Q9, ICH Q10, ICH Q11 and ICH Q12 published by the International Harmonization Commission (ICH) detail the scientific and innovative design and quality perception required to ensuring consistent product quality [3]. When the literature is examined, while there are a large number of studies [4][5][6][7][8][9][10][11][12] in which QbD and Process Analytical Technology (PAT) applications are analyzed, it is obvious that conducting more research in this area is necessary as the benefits of the field are taken into consideration. The approach of designing pharmaceutical products with quality rather than testing the final product during the pharmaceutical product development process, which is difficult and costly, is a topic that attracts growing interest.…”