How do I structure logistic processes in preparation for outsourcing of cellular therapy manufacturing?

Chen, Leonard N.; Collins‐Johnson, Naoza; Sapp, Nasheda; Pickett, Angela; West, Kamille A.; Stroncek, David F.; Panch, Sandhya R.

doi:10.1111/trf.15349

Cited by 14 publications

(8 citation statements)

References 58 publications

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“…Hematopoietic stem cell (HSC) transplantation is often a last resort for patients battling various inherited or acquired conditions [ 1 , 2 ]. With donors coming from international and intercontinental sources, safe and effective cell storage is an essential step in the transplant procedure to accommodate graft inventory, logistics, transportation, quality control testing, and major histocompatibility matching of the donors and recipients [ 3 – 5 ].…”

Section: Introductionmentioning

confidence: 99%

A bioinspired and chemically defined alternative to dimethyl sulfoxide for the cryopreservation of human hematopoietic stem cells

Gilfanova

Callegari

Childs

et al. 2021

Bone Marrow Transplant

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The cryopreservation of hematopoietic cells using dimethyl sulfoxide (DMSO) and serum is a common procedure used in transplantation. However, DMSO has clinical and biological side effects due to its toxicity, and serum introduces variation and safety risks. Inspired by natural antifreeze proteins, a novel class of ice-interactive cryoprotectants was developed. The corresponding DMSO-, protein-, and serum-free cryopreservation media candidates were screened through a series of biological assays using human cell lines, peripheral blood cells, and bone marrow cells. XT-Thrive-A and XT-Thrive-B were identified as lead candidates to rival cryopreservation with 10% DMSO in serum based on post-thaw cell survival and short-term proliferation assays. The effectiveness of the novel cryopreservation media in freezing hematopoietic stem cells from human whole bone marrow was assessed by extreme limiting dilution analysis in immunodeficient mice. Stem cell frequencies were measured 12 weeks after transplant based on bone marrow engraftment of erythroid, myeloid, B-lymphoid, and CD34+ progenitors measured by flow cytometry. The recovered numbers of cryopreserved stem cells were similar among XT-Thrive A, XT-Thrive B, and DMSO with serum groups. These findings show that cryoprotectants developed through biomimicry of natural antifreeze proteins offers a substitute for DMSO-based media for the cryopreservation of hematopoietic stem cells.

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Section: Introductionmentioning

confidence: 99%

A bioinspired and chemically defined alternative to dimethyl sulfoxide for the cryopreservation of human hematopoietic stem cells

Gilfanova

Callegari

Childs

et al. 2021

Bone Marrow Transplant

View full text Add to dashboard Cite

show abstract

“…This variability creates additional work for medical center-based cell processing laboratory staff. In addition, our and other medical center-based laboratories have dedicated staff who spend a significant amount of time managing logistics with each centralized manufacturing laboratory, including the coordination of product shipping and receipt [ 5 ].…”

Section: Commentarymentioning

confidence: 99%

The need for uniform and coordinated practices involving centrally manufactured cell therapies

et al. 2022

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Cellular therapies have become an important part of clinical care. The treatment of patients with cell therapies often involves the collection of autologous cells at the medical center treating the patient, the shipment of these cells to a centralized manufacturing site, and the return of the cryopreserved clinical cell therapy to the medical center treating the patient for storage until infusion. As this activity grows, cell processing laboratories at many academic medical centers are involved with many different autologous products manufactured by several different centralized laboratories. The handling of these products by medical center-based cell therapy laboratories is complicated and resource-intensive since each centralized manufacturing laboratory has unique methods for labeling, storing, shipping, receiving, thawing, and infusing the cells. The field would benefit from the development of more uniform practices. The development of a coordinating center similar to those established to facilitate the collection, shipping, and transplantation of hematopoietic stem cells from unrelated donors would also be beneficial. In summary, the wide range of practices involved with labeling, shipping, freezing, thawing, and infusing centrally manufactured autologous cellular therapies lack efficiency and consistency and puts patients at risk. More uniform practices are needed.

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“…Raw material suppliers are evolving to focus on chemically defined and animal‐component free products to improve consistency and ensure a sufficient standard of quality, [ 12,13 ] and supply chain solutions are supporting wide‐reaching distribution with appropriate traceability. [ 14,15 ] Industrial bioprocess strategies adapted from more mature biologics fields are starting to be implemented in CGT manufacturing. [ 16,17 ] The incorporation of these strategies with increased rigour are critical for the evolution of CGT to a more mature and robust field.…”

Section: Manufacturing Of Cell and Gene Therapy Products Requires A Framework To Support Continuing Innovationmentioning

confidence: 99%

Process evolution in cell and gene therapy from discovery to commercialization

Csaszar¹,

Mills²,

Zandstra

2021

Can J Chem Eng

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The field of cell and gene therapy (CGT) is maturing at a rapid rate. Manufacturing remains a major challenge and manufacturing failures and limitations are a notable source of CGT products not meeting specification or being held back from regulatory approvals. To ensure that products remain compliant and competitive throughout their lifecycle, CGT process development requires both ongoing advancement of fit‐for‐purpose technologies to allow for and support well‐designed development studies, and a methodology that enables these studies to occur effectively during focused product development campaigns. We describe a framework for ongoing innovation in CGT process development, manufacturing, and clinical testing, based on the quality by design (QbD) approach. We propose use of the concepts of process discovery, process characterization, and process development in an iterative way to refine the design space as a product matures. This strategy is enabled by the early implementation of broad and robust analytics, and a modular approach to accelerate optimization. With these strategies, CGT developers can prospectively plan for comparability studies and develop in a stage‐appropriate manner, to allow for ongoing innovation and improvements from discovery through to commercialization.

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How do I structure logistic processes in preparation for outsourcing of cellular therapy manufacturing?

Cited by 14 publications

References 58 publications

A bioinspired and chemically defined alternative to dimethyl sulfoxide for the cryopreservation of human hematopoietic stem cells

A bioinspired and chemically defined alternative to dimethyl sulfoxide for the cryopreservation of human hematopoietic stem cells

The need for uniform and coordinated practices involving centrally manufactured cell therapies

Process evolution in cell and gene therapy from discovery to commercialization

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