LIVIVO - Search results -

Search results

Result 1 - 10 of total 274

Search options

Article ; Online: Healthcare center-based cell therapy laboratories supporting off-site manufactured cell therapies: The experiences of a single academic cell therapy laboratory.

Dinh, Anh / Stroncek, David F

2024 Volume 64, Issue 2, Page(s) 357–366

Abstract: Background: Healthcare center-based cell therapy laboratories (HC CTLs) evolved from solely processing hematopoietic stem cells for transplantation to manufacturing various advanced cellular therapies. With increasing interest in cellular therapy ... ...

Abstract	Background: Healthcare center-based cell therapy laboratories (HC CTLs) evolved from solely processing hematopoietic stem cells for transplantation to manufacturing various advanced cellular therapies. With increasing interest in cellular therapy applications, off-site manufactured products are becoming more common. HC CTLs play a critical role in supporting these products by shipping out cellular starting material (CSM) for further manufacturing and/or receiving, storing, and distributing final products. The experiences and challenges encountered by a single academic HC CTL in supporting these products are presented. Methods: All off-site manufacturing protocols supported before 2023 were reviewed. Collected data included protocol characteristics (treatment indication, product type), process logistics (shipping, receiving, storage, thawing, distribution, documentation), and product handling volumes (CSM shipping and final product infusions). Results: Between 2012 and 2022, 15 off-site manufactured cellular therapy early-phase, single- and multicenter clinical trials were supported. Trials were sponsored by academic/research and commercial entities. The number of protocols supported annually increased each year, with few ending. Products included cancer immunotherapies and gene therapies. Autologous CSM was collected and shipped, while autologous and allogeneic final products were received, stored, thawed, and distributed. Process differences among protocols included CSM shipping conditions, laboratory analyses, final product thaw conditions and procedures, number of treatments, and documentation. Discussion: HC CTLs must contend with several challenges in supporting off-site manufacturing protocols. As demand for cellular therapies increases, stakeholders should collaborate from the early phases of clinical trials to streamline processes and standardize procedures to increase value, improve safety, and reduce the burden on HC CTLs.
MeSH term(s)	Humans ; Laboratories ; Hematopoietic Stem Cells ; Cell- and Tissue-Based Therapy ; Immunotherapy ; Delivery of Health Care
Language	English
Publishing date	2024-01-03
Publishing country	United States
Document type	Multicenter Study ; Journal Article
ZDB-ID	208417-x
ISSN	1537-2995 ; 0041-1132
ISSN (online)	1537-2995
ISSN	0041-1132
DOI	10.1111/trf.17703
Database	MEDical Literature Analysis and Retrieval System OnLINE

In stock of ZB MED Cologne/Königswinter

Zs.A 284: Show issues

Location:
Je nach Verfügbarkeit (siehe Angabe bei Bestand)
bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
Jg. 1995 - 2021: Lesesall (1.OG)
ab Jg. 2022: Lesesaal (EG)

Order via subito

This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

Details ▾
- See ZB MED holdings
- Order with fees

Article ; Online: Expanding the reach of commercial cell therapies requires changes at medical centers.

Stroncek, David F / Zhang, Nan / Ren, Jiaqiang / Somerville, Rob / Dinh, Anh

Journal of translational medicine

2024 Volume 22, Issue 1, Page(s) 181

Abstract: The clinical application of cell therapies is becoming increasingly important for the treatment of cancer, congenital immune deficiencies, and hemoglobinopathies. These therapies have been primarily manufactured and used at academic medical centers. ... ...

Abstract	The clinical application of cell therapies is becoming increasingly important for the treatment of cancer, congenital immune deficiencies, and hemoglobinopathies. These therapies have been primarily manufactured and used at academic medical centers. However, cell therapies are now increasingly being produced in centralized manufacturing facilities and shipped to medical centers for administration. Typically, these cell therapies are produced from a patient's own cells, which are the critical starting material. For these therapies to achieve their full potential, more medical centers must develop the infrastructure to collect, label, cryopreserve, test, and ship these cells to the centralized laboratories where these cell therapies are manufactured. Medical centers must also develop systems to receive, store, and infuse the finished cell therapy products. Since most cell therapies are cryopreserved for shipment and storage, medical centers using these therapies will require access to liquid nitrogen product storage tanks and develop procedures to thaw cell therapies. These services could be provided by the hospital pharmacy or transfusion service, but the latter is likely most appropriate. Another barrier to implementing these services is the variability among providers of these cell therapies in the processes related to handling cell therapies. The provision of these services by medical centers would be facilitated by establishing a national coordinating center and a network of apheresis centers to collect and cryopreserve the cells needed to begin the manufacturing process and cell therapy laboratories to store and issue the cells. In addition to organizing cell collections, the coordinating center could establish uniform practices for collecting, labeling, shipping, receiving, thawing, and infusing the cell therapy.
MeSH term(s)	Humans ; Academic Medical Centers ; Cell- and Tissue-Based Therapy
Language	English
Publishing date	2024-02-19
Publishing country	England
Document type	Journal Article
ZDB-ID	2118570-0
ISSN	1479-5876 ; 1479-5876
ISSN (online)	1479-5876
ISSN	1479-5876
DOI	10.1186/s12967-024-04966-6
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

Article ; Online: Point-of-care cell therapy manufacturing; it's not for everyone.

Stroncek, David F / Somerville, Robert P T / Highfill, Steven L

Journal of translational medicine

2022 Volume 20, Issue 1, Page(s) 34

Abstract: The use of cellular therapies to treat cancer, inherited immune deficiencies, hemoglobinopathies and viral infections is growing rapidly. The increased interest in cellular therapies has led to the development of reagents and closed-system automated ... ...

Abstract	The use of cellular therapies to treat cancer, inherited immune deficiencies, hemoglobinopathies and viral infections is growing rapidly. The increased interest in cellular therapies has led to the development of reagents and closed-system automated instruments for the production of these therapies. For cellular therapy clinical trials involving multiple sites some people are advocating a decentralized model of manufacturing where patients are treated with cells produced using automated instruments at each participating center using a single, centrally held Investigational New Drug Application (IND). Many academic centers are purchasing these automated instruments for point-of-care manufacturing and participation in decentralized multiple center clinical trials. However, multiple site manufacturing requires harmonization of product testing and manufacturing in order to interpret the clinical trial results. Decentralized manufacturing is quite challenging since all centers should use the same manufacturing protocol, the same or comparable in-process and lot release assays and the quality programs from each center must work closely together. Consequently, manufacturing cellular therapies using a decentralized model is in many ways more difficult than manufacturing cells in a single centralized facility. Before an academic center decides to establish a point-of-care cell processing laboratory, they should consider all costs associated with such a program. For many academic cell processing centers, point-of-care manufacturing may not be a good investment.
MeSH term(s)	Cell- and Tissue-Based Therapy ; Humans ; Neoplasms ; Point-of-Care Systems
Language	English
Publishing date	2022-01-15
Publishing country	England
Document type	Letter ; Research Support, N.I.H., Intramural
ZDB-ID	2118570-0
ISSN	1479-5876 ; 1479-5876
ISSN (online)	1479-5876
ISSN	1479-5876
DOI	10.1186/s12967-022-03238-5
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

Article ; Online: Scaling up and scaling out: Advances and challenges in manufacturing engineered T cell therapies.

Song, Hannah W / Somerville, Robert P / Stroncek, David F / Highfill, Steven L

International reviews of immunology

2022 Volume 41, Issue 6, Page(s) 638–648

Abstract: Engineered T cell therapies such as CAR-T cells and TCR-T cells have generated impressive patient responses in previously incurable diseases. In the past few years there have been a number of technical innovations that enable robust clinical ... ...

Abstract	Engineered T cell therapies such as CAR-T cells and TCR-T cells have generated impressive patient responses in previously incurable diseases. In the past few years there have been a number of technical innovations that enable robust clinical manufacturing in functionally closed and often automated systems. Here we describe the latest technology used to manufacture CAR- and TCR-engineered T cells in the clinic, including cell purification, transduction/transfection, expansion and harvest. To help compare the different systems available, we present three case studies of engineered T cells manufactured for phase I clinical trials at the NIH Clinical Center (CD30 CAR-T cells for lymphoma, CD19/CD22 bispecific CAR-T cells for B cell malignancies, and E7 TCR T cells for human papilloma virus-associated cancers). Continued improvement in cell manufacturing technology will help enable world-wide implementation of engineered T cell therapies.
MeSH term(s)	Humans ; Receptors, Antigen, T-Cell/genetics ; Immunotherapy, Adoptive ; T-Lymphocytes ; Neoplasms/therapy ; B-Lymphocytes
Chemical Substances	Receptors, Antigen, T-Cell
Language	English
Publishing date	2022-04-29
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Intramural
ZDB-ID	632825-8
ISSN	1563-5244 ; 1545-5858 ; 0883-0185
ISSN (online)	1563-5244 ; 1545-5858
ISSN	0883-0185
DOI	10.1080/08830185.2022.2067154
Database	MEDical Literature Analysis and Retrieval System OnLINE

In stock of ZB MED Cologne/Königswinter

Zs.A 2156: Show issues

Location:
Je nach Verfügbarkeit (siehe Angabe bei Bestand)
bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
Jg. 1995 - 2021: Lesesall (1.OG)
ab Jg. 2022: Lesesaal (EG)

Order via subito

Details ▾
- See ZB MED holdings
- Order with fees

Article ; Online: Overcoming Challenges in Process Development of Cellular Therapies.

Highfill, Steven L / Stroncek, David F

Current hematologic malignancy reports

2019 Volume 14, Issue 4, Page(s) 269–277

Abstract: Purpose of the review: Cellular therapy using chimeric antigen receptor (CAR) T cells as a treatment option for patients with lymphoma and leukemia has proven to be remarkably efficacious. This success has sparked the development of new cellular therapy ...

Abstract	Purpose of the review: Cellular therapy using chimeric antigen receptor (CAR) T cells as a treatment option for patients with lymphoma and leukemia has proven to be remarkably efficacious. This success has sparked the development of new cellular therapy products for numerous indications. Similar to pharmaceutical products, challenges exist at nearly every stage of process development; however, the unique nature of a cellular therapy product can present exceptional challenges that are just beginning to emerge. The purpose of this review is to explore some of the most common challenges experienced during the early phases of development of CAR T cell products and to provide suggestions for navigating these challenges. Recent findings: Recent articles focused on CAR T cells are highlighted with special attention on aspects that relate to CAR T cell process development and clinical manufacturing. We examine the various stages of process development for CAR T cells and outline some of the obstacles that must be overcome in order to move from pre-clinical development into clinical manufacturing. As the field of CAR T cell therapy continues to grow, it is important to quickly move new CAR T cell products into and through early phase clinical trials and to ensure that the result of these trials can be adequately compared. Having laboratory and clinical investigators and GMP manufacturing facilities aligned on the numerous aspects of new product development will facilitate this process.
MeSH term(s)	Animals ; Antibodies/immunology ; Antigen-Presenting Cells/immunology ; Antigen-Presenting Cells/metabolism ; Batch Cell Culture Techniques ; Bioreactors ; Cell Culture Techniques ; Cell Engineering/methods ; Cell Separation/methods ; Cell- and Tissue-Based Therapy/adverse effects ; Cell- and Tissue-Based Therapy/methods ; Cell- and Tissue-Based Therapy/standards ; Cytokines/metabolism ; Gene Transfer Techniques ; Genetic Engineering/methods ; Humans ; Immunotherapy, Adoptive ; Receptors, Antigen, T-Cell/genetics ; Receptors, Antigen, T-Cell/metabolism ; Receptors, Chimeric Antigen/genetics ; Receptors, Chimeric Antigen/metabolism ; T-Lymphocytes/immunology ; T-Lymphocytes/metabolism
Chemical Substances	Antibodies ; Cytokines ; Receptors, Antigen, T-Cell ; Receptors, Chimeric Antigen
Language	English
Publishing date	2019-07-07
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2229765-0
ISSN	1558-822X ; 1558-8211
ISSN (online)	1558-822X
ISSN	1558-8211
DOI	10.1007/s11899-019-00529-5
Database	MEDical Literature Analysis and Retrieval System OnLINE

Full text online

Accessible to users with ZB MED library card

In stock of ZB MED Cologne/Königswinter

Zs.A 6332: Show issues

Location:
Je nach Verfügbarkeit (siehe Angabe bei Bestand)
bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
ab Jg. 2022: Lesesaal (EG)

Order via subito

Details ▾

Article: Blood Research: hematology and beyond.

Stroncek, David F

Blood research

2013 Volume 48, Issue 1, Page(s) 1–2

Language	English
Publishing date	2013-03-26
Publishing country	Korea (South)
Document type	Journal Article
ZDB-ID	2711910-5
ISSN	2288-0011 ; 2287-979X
ISSN (online)	2288-0011
ISSN	2287-979X
DOI	10.5045/br.2013.48.1.1
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

Article ; Online: Improving CAR T cell therapy by optimizing critical quality attributes.

Reddy, Opal L / Stroncek, David F / Panch, Sandhya R

Seminars in hematology

2020 Volume 57, Issue 2, Page(s) 33–38

Abstract: Whether as a cure or bridge to transplant, chimeric antigen receptor (CAR)-T cell therapies have shown dramatic outcomes for the treatment of hematologic malignancies, and particularly relapsed/refractory B cell leukemia and lymphoma. However, these ... ...

Abstract	Whether as a cure or bridge to transplant, chimeric antigen receptor (CAR)-T cell therapies have shown dramatic outcomes for the treatment of hematologic malignancies, and particularly relapsed/refractory B cell leukemia and lymphoma. However, these therapies are not effective for all patients, and are not without toxicities. The challenge now is to optimize these products and their manufacture. The manufacturing process is complex and subject to numerous variabilities at each step. These variabilities can affect the critical quality attributes of the final product, and this can ultimately impact clinical outcomes. This review will focus on optimizing the manufacturing variables that can impact the safety, purity, potency, consistency and durability of CAR-T cells.
MeSH term(s)	Hematologic Neoplasms/immunology ; Hematologic Neoplasms/therapy ; Humans ; Immunotherapy, Adoptive/methods ; Receptors, Antigen, T-Cell/therapeutic use
Chemical Substances	Receptors, Antigen, T-Cell
Language	English
Publishing date	2020-07-27
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	206923-4
ISSN	1532-8686 ; 0037-1963
ISSN (online)	1532-8686
ISSN	0037-1963
DOI	10.1053/j.seminhematol.2020.07.005
Database	MEDical Literature Analysis and Retrieval System OnLINE

In stock of ZB MED Cologne/Königswinter

Zs.A 328: Show issues

Location:
Je nach Verfügbarkeit (siehe Angabe bei Bestand)
bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
Jg. 1995 - 2021: Lesesall (1.OG)
ab Jg. 2022: Lesesaal (EG)

Order via subito

Details ▾
- See ZB MED holdings
- Order with fees

Article ; Online: Transfusion Support in Patients with Hematologic Disease: New and Novel Transfusion Modalities.

Panch, Sandhya R / Savani, Bipin N / Stroncek, David F

Seminars in hematology

2019 Volume 56, Issue 4, Page(s) 227–228

Language	English
Publishing date	2019-12-11
Publishing country	United States
Document type	Editorial
ZDB-ID	206923-4
ISSN	1532-8686 ; 0037-1963
ISSN (online)	1532-8686
ISSN	0037-1963
DOI	10.1053/j.seminhematol.2019.11.007
Database	MEDical Literature Analysis and Retrieval System OnLINE

In stock of ZB MED Cologne/Königswinter

Zs.A 328: Show issues

Location:
Je nach Verfügbarkeit (siehe Angabe bei Bestand)
bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
Jg. 1995 - 2021: Lesesall (1.OG)
ab Jg. 2022: Lesesaal (EG)

Order via subito

Details ▾
- See ZB MED holdings
- Order with fees

Article ; Online: Point-of-care cell therapy manufacturing; it’s not for everyone

David F. Stroncek / Robert P. T. Somerville / Steven L. Highfill

Journal of Translational Medicine, Vol 20, Iss 1, Pp 1-

2022 Volume 3

Abstract: Abstract The use of cellular therapies to treat cancer, inherited immune deficiencies, hemoglobinopathies and viral infections is growing rapidly. The increased interest in cellular therapies has led to the development of reagents and closed-system ... ...

Abstract	Abstract The use of cellular therapies to treat cancer, inherited immune deficiencies, hemoglobinopathies and viral infections is growing rapidly. The increased interest in cellular therapies has led to the development of reagents and closed-system automated instruments for the production of these therapies. For cellular therapy clinical trials involving multiple sites some people are advocating a decentralized model of manufacturing where patients are treated with cells produced using automated instruments at each participating center using a single, centrally held Investigational New Drug Application (IND). Many academic centers are purchasing these automated instruments for point-of-care manufacturing and participation in decentralized multiple center clinical trials. However, multiple site manufacturing requires harmonization of product testing and manufacturing in order to interpret the clinical trial results. Decentralized manufacturing is quite challenging since all centers should use the same manufacturing protocol, the same or comparable in-process and lot release assays and the quality programs from each center must work closely together. Consequently, manufacturing cellular therapies using a decentralized model is in many ways more difficult than manufacturing cells in a single centralized facility. Before an academic center decides to establish a point-of-care cell processing laboratory, they should consider all costs associated with such a program. For many academic cell processing centers, point-of-care manufacturing may not be a good investment.
Keywords	Cell therapy ; Gene therapy ; Cancer immunotherapy ; Point-of-care manufacturing ; Decentralized manufacturing ; Medicine ; R
Subject code	629
Language	English
Publishing date	2022-01-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

Full text online

Full text

Inter-library loan at ZB MED

Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

Article ; Online: Gene therapy simplified.

Ren, Jiaqiang / Stroncek, David F

Blood

2016 Volume 128, Issue 18, Page(s) 2194–2195

MeSH term(s)	Genetic Therapy ; Humans
Language	English
Publishing date	2016-11-03
Publishing country	United States
Document type	Journal Article ; Comment
ZDB-ID	80069-7
ISSN	1528-0020 ; 0006-4971
ISSN (online)	1528-0020
ISSN	0006-4971
DOI	10.1182/blood-2016-09-736983
Database	MEDical Literature Analysis and Retrieval System OnLINE

In stock of ZB MED Cologne/Königswinter

Uh III Zs.140: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG)
Zs.MO 364: Show issues

Order via subito

Details ▾
- See ZB MED holdings
- Order with fees

To top

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

More links

Kategorien

Order via subito

More links

Kategorien

Order via subito

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

Full text online

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

More links

Kategorien

Order via subito

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

Full text online

More links

Kategorien

Inter-library loan at ZB MED

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito