Figure 1. Alternative routes for manufacturing, distribution and delivery of small scale more-than-minimally manipulated autologous cell therapy products.

Figure 1

Alternative routes for manufacturing, distribution and delivery of small scale more-than-minimally manipulated autologous cell therapy products. Approaches may involve (i) a regulated central processing facility (B1 or A2) serving a number of clinical sites in which the patient travels to the clinical site/specialised centre for treatment. Cells are removed from the patient (C1) and transferred to the regulated manufacturing site (B1 or A2) before being returned back to the clinical site for administration to the patient either directly as fresh product (C2) or following further processing (cryo-recovery) (C1) or (ii) a distributed model that requires localised processing within a hospital unit (C1) or manufacturing in-theatre or at the bedside (C2), in which cells are removed from patients and processed locally by means of a closed, automated processing system(s) before being reintroduced into the patient on-site. The origin and scale of the potential routes for manufacturing scale/roll-out to multiple sites may involve transfer of a manufacturing process and product (iii) from an academic (A1) or hospital laboratory (C1) to a regulated manufacturing site (B1 or A2); (iv) to one or more additional production lines within the same facility or to a regulated manufacturing site(s) (D) within the same jurisdiction, either before or after Phase III clinical trials (i.e. pre- or post-Marketing Authorisation Application (MAA)) or to regulated manufacturing site(s) within different jurisdictions, or (v) to processing sites in International Clinical Centres of Excellence for major clinical specialisms (C2). Potential routes may also involve the roll-out of self-contained manufacturing platforms, standardised reagents and protocols (B2) close to the clinic (C2) or to local production hubs (D).

From: Regulatory challenges for the manufacture and scale-out of autologous cell therapies

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Cambridge (MA): Harvard Stem Cell Institute; 2008-.
Copyright: © 2014 Paul Hourd, Amit Chandra, Nick Medcalf and David J. Williams.

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