[HTML][HTML] Centralised versus decentralised manufacturing and the delivery of healthcare products: A United Kingdom exemplar

RP Harrison, QA Rafiq, N Medcalf - Cytotherapy, 2018 - Elsevier
Background The cell and gene therapy (CGT) field is at a critical juncture. Clinical successes
have underpinned the requirement for developing manufacturing capacity suited to patient …

[HTML][HTML] Decentralised manufacturing of cell and gene therapy products: Learning from other healthcare sectors

RP Harrison, S Ruck, QA Rafiq, N Medcalf - Biotechnology advances, 2018 - Elsevier
Decentralised or 'redistributed'manufacturing represents an attractive choice for production
of some cell and gene therapies (CGTs), in particular personalised therapies. Decentralised …

[HTML][HTML] Decentralized manufacturing of cell and gene therapies: Overcoming challenges and identifying opportunities

RP Harrison, S Ruck, N Medcalf, QA Rafiq - Cytotherapy, 2017 - Elsevier
Decentralized or “redistributed” manufacturing has the potential to revolutionize the
manufacturing approach for cell and gene therapies (CGTs), moving away from the “Fordist” …

[HTML][HTML] Estimation of manufacturing development costs of cell-based therapies: a feasibility study

RMT Ten Ham, JC Nievaart, J Hoekman, RS Cooper… - Cytotherapy, 2021 - Elsevier
Background aims Cell-based therapies (CBTs) provide opportunities to treat rare and high-
burden diseases. Manufacturing development of these innovative products is said to be …

Cell therapy-processing economics: small-scale microfactories as a stepping stone toward large-scale macrofactories

RP Harrison, N Medcalf, QA Rafiq - Regenerative medicine, 2018 - Taylor & Francis
Aim: Manufacturing methods for cell-based therapies differ markedly from those established
for noncellular pharmaceuticals and biologics. Attempts to 'shoehorn'these into existing …

[HTML][HTML] Cell and gene therapy manufacturing capabilities in Australia and New Zealand

GM O'SULLIVAN, ZM Velickovic, MW Keir… - Cytotherapy, 2019 - Elsevier
Cell and gene therapy products are rapidly being integrated into mainstream medicine.
Developing global capability will facilitate broad access to these novel therapeutics. An …

[HTML][HTML] What does cell therapy manufacturing cost? A framework and methodology to facilitate academic and other small-scale cell therapy manufacturing costings

RMT Ten Ham, AM Hövels, J Hoekman, GWJ Frederix… - Cytotherapy, 2020 - Elsevier
Background aims Recent technical and clinical advances with cell-based therapies (CBTs)
hold great promise in the treatment of patients with rare diseases and those with high unmet …

[HTML][HTML] Manufacturing models permitting roll out/scale out of clinically led autologous cell therapies: regulatory and scientific challenges for comparability

P Hourd, P Ginty, A Chandra, DJ Williams - Cytotherapy, 2014 - Elsevier
Manufacturing of more-than-minimally manipulated autologous cell therapies presents a
number of unique challenges driven by complex supply logistics and the need to scale out …

[HTML][HTML] Centralized or decentralized manufacturing? Key business model considerations for cell therapies

N Medcalf - Cell and Gene Therapy Insights, 2016 - insights.bio
The choice of manufacturing strategy for cell-based therapeutics is one that is best made
early in product development. Expense and delay may result from any additional bridging …

Addressing the manufacturing challenges of cell-based therapies

M de Almeida Fuzeta, AD de Matos Branco… - Current applications of …, 2020 - Springer
Exciting developments in the cell therapy field over the last decades have led to an
increasing number of clinical trials and the first cell products receiving marketing …