Cell Therapy Value Chain

Part
01
of three
Part
01

Cell Therapy Value Chain - Research and Development

There are several reports published by BioInsights, BioProcess International, Cell & Gene, and Onco'zine, among others that provide insights into the research and development in cell therapy value chain. A list of 15 reports covering research and development in cell therapy value chain can be found below:

1) BUILDING NEW BUSINESS MODELS TO SUPPORT CELL AND GENE THERAPY R&D

  • This report is available for free.
  • Publisher: Cell & Gene
  • The report suggests that new business models must be developed to support cell therapy R&D. The report further states that new models will be dependent on the curative efficacy of therapies and the development of new delivery techniques for cell therapies.

2) BENCHLING FOR CELL THERAPY R&D

  • This white paper is available for free.
  • Publisher: Benchling
  • The white paper discusses the challenges and complexities associated with the development of cell therapies. It also highlights the role of Benchling in cell therapy R&D, i.e., managing DNA constructs, editing genetic codes, categorizing cell products, and scaling up therapies, among others.

3) GENE AND CELL THERAPY: THE R&D AND MARKET INSIGHTS YOU NEED TO GET A COMPETITIVE EDGE

  • This report is available for free.
  • Publisher: CAS
  • The report states that a notable increase in cell therapy research has been observed lately, with more than 113,229 patent applications been filed until 2017. The report further highlights recent developments such as stem cell therapies, CAR T-cell therapies, and gene-editing technology.

4) MEDICINES IN DEVELOPMENT FOR CELL THERAPY AND GENE THERAPY

  • This report is available for free.
  • The 2018 Medicines in Development report states that 289 cell and gene therapies (CGTs) are in the development phase for a broad range of diseases.

5) PERSONALIZED GENE-EDITED IMMUNE CELL THERAPY MAY HELP PATIENTS WITH SOLID CANCERS

  • This report is available for free.
  • Publisher: Onco'Zine
  • This report states that researchers have identified the 'private' signatures for tumor mutations in cancer patients. The signatures can be used to research and develop target-specific cell therapies for cancer patients.

6) FDA SEEKS TO ENHANCE MANUFACTURING OF CELL AND GENE THERAPIES

7) THE FUTURE OF CELL AND GENE THERAPY

  • This report is available for free.
  • Publisher: Pharmaceutical Executive
  • The report discusses the future of gene and cell therapies. It highlights the therapeutic potential, research maturity, and competitive landscape of research and development efforts for CGTs.

8) THE REGENERATIVE MEDICINE STANDARDS LANDSCAPE

9) BIOLOGICS IN THERAPIES RESEARCH AND DEVELOPMENT

10) GENE AND CELL THERAPY RESEARCH & DEVELOPMENT

  • This report is available for free.
  • Publisher: CAS
  • This report discusses the global research and development technology trends for gene and cell therapies.

11) DESIGNING THE FUTURE OF CELL THERAPIES

12) GETTING THE MOST OUT OF YOUR CAR-T BIOPROCESSING WITH THE CLINIMACS PRODIGY & ISOCODE SINGLE-CELL CHIP

  • This report is available for free.
  • This technical note published by Isoplexis highlights the recent development of automated CAR-T cell production and cell analysis. The company has published about the optimization of cell therapy using the CliniMACS Prodigy and IsoPlexis’ IsoLight system.

13) LATEST ADVANCES IN BIOPROCESSING: OVERCOMING BOTTLENECKS

  • This report is available for free.
  • Publisher: BioInsights
  • This report discusses the latest advancements in cell therapy bioprocessing along with the steps being taken to address the bottlenecks for scaling up to commercialization.

14) PHACILITATE AUTOMATION SIG: 2018 REPORT

  • This report is available for free.
  • The Phacilitate Automation SIG Report 2018 provides insights into the development of automation for cell therapies. The report also discusses the tools, platforms, and processes for the genetic manipulation of cell therapies.

15) SOURCING CLINICAL-GRADE HUMAN TISSUE: CONSIDERATIONS FOR SUPPORTING CELL THERAPY DEVELOPMENT AND PRODUCTION

  • This report is available for free.
  • Publisher: BioProcess International
  • This report highlights the growing need for sourcing “Clinical-Grade” human tissues for the development and production of cell therapies.
Part
02
of three
Part
02

Cell Therapy Value Chain - Supply Chain Management

The reports highlight the supply chain management of cell therapies by detailing future outlook, challenges, key considerations, process automation, among others. We came across reports from notable publishers like BioInsights, BioPharma Reporter, Clinical Trials Arena, and Medicine Maker. The list of 15 reports detailing the supply chain management for cell therapies is compiled in this research.

SUPPLY CHAIN MANAGEMENT OF CELL THERAPIES

1) Free access report link: "The Impact of Gene and Cell Therapy on the Supply Chain" (2018)
  • The report by Clinical Trails Arena describes the impact of cell therapies on the supply chain. Further, it details the market place perspective, industry perspective, sourcing considerations, and last-mile delivery aspects of the cell therapies.

2) Free access report link: "Novel supply chain and process modeling for cell therapy manufacturing and distribution" (2019)

3) Free access report link: "The Unique Demands of Cell and Gene Therapy Supply Chains" (2019)
  • The report by Life Science Leader details the unique requirements for supplying gene and cell therapies. It discusses how CMOs can manage cell therapy supply chains successfully.

4) Free access report link: "21 Critical Supply Chain Tips for Cell Therapies" (2019)
  • Healthcare Packaging recently published a report featuring 21 tips for successfully managing supply chain requirements for cell therapies. Some critical factors include mapping out schedules, consideration of seasonal conditions, accurate patient identification, among others.

5) Free access report link: "World Courier Weighs In On Logistics Of Cell & Gene Therapy Supply Chain" (2018)
  • This report details an interview with Simon Ellison, the service director at World Courier. Simon discusses the current supply chain landscape for cell therapy, the future of personalized supply chains, industry challenges, and the impact on pharmaceutical manufacturers.

6) Free access report link: "Entire cell therapy sector realizes importance of supply chain management" (2019)
  • A recent report by BioPharma Reporter reveals that the supply chain can impact the entire cell therapy industry. Further, it describes features of the TrackCel platform for tracking personalized therapy deliveries.

7) Free access report link: "Cell and Gene Therapies 2018: State of the Industry Report" (2018)

8) Free access report link: "Cryoport’s CEO on cell therapies’ market robust demand" (2019)
  • Another report by BioPharma Reporter discusses the new logistical requirements, logistics competition, regulatory considerations, and specialized needs for supplying cellular therapies.

9) Free access report link: "Designing a Robust and Cost-Effective 'Off-the-shelf' Supply Chain for Osteoblastic Cell Therapy" (2018)
  • A report by Bone Therapeutics details the concept of a cost-effective and robust 'off-the-shelf' supply chain designed for delivering osteoblastic cell therapies.

10) Free access report link: "Cell Therapy Logistics" (2018)
  • The report by Fisher Clinical Services highlights the standardization, validation, and monitoring of supply chain procedures for cell therapy.

11) Free access report link: "Commercially Successful Cell Therapies: Navigating the Ultra Cold Chain Distribution Minefield" (2018)

12) Free access report link: "Personalized supply chains for cell therapies" (2017)

13) Free access report link: "White Paper: 13 Ways Logistics Specialists are Transforming Cell and Gene Therapy Supply Chains" (2018)
  • The white paper by World Courier details the transformation efforts of logistics specialists to offer cell therapy supply chain solutions. Some notable ones include data integration, developing scalable processes, testing innovations, among others.

14) Free access report link: "In the Land of the Living Logistics" (2019)
  • A report by Medicine Maker details the importance of supply chain automation while handling cell therapies.

15) Free access report link: "Logistical considerations of the cell therapy supply chain at the point of care" (2018)
  • The report by BioInsights presents an interview discussion with Karen Coopman about the logistical and supply chain considerations for handling cell therapies at the point of care.

Part
03
of three
Part
03

Cell Therapy Value Chain - Commercialization

The reports highlight the commercialization of cell therapies by detailing future outlook, challenges, successful examples, key considerations, opportunities, among others. We came across reports from notable publishers like BioInsights, BioProcess International, Deloitte, Cell Culture Dish, Amerisource Bergen, HOPA. The list of 15 reports detailing the value chain commercialization for cell therapies is compiled in the report.

COMMERCIALIZATION OF CELL THERAPIES

1) Free access report link: "A Perspective on GMPs for Cellular Therapy Commercialization"
  • A recent report by BioProcess International details about the standardization of cell therapy for commercialization, using Good Manufacturing Practices (GMPs). Further, the report discusses regulatory requirements for cell therapies followed by cell sourcing, processing, and distribution for therapies.

2) Free access report link: "The Link Between Manufacturing and Commercialization in Gene and Cell Therapy"

3) Free access report link: "Commercial Lessons for Clinical Success"
  • The report by BioInsights maps out the key processes to be considered at every clinical phase for successful the commercialization of cell therapies.

4) Free access report link: "Commercializing Cell Therapy with Argos Therapeutics"
  • The case study by Clarkson Consulting details about a personalized commercialization process delivered to Argos Therapeutics for their phase-3 autologous immunotherapy product.

5) Free access report link: "Cell and Gene Therapies: Paving the Commercial Pathways of Tomorrow"
  • The thought leadership report by CB Partners discusses the commercial challenges, future outlook, financial gains, and profitability of ventures that should be considered for commercialization of cell and gene therapies by biopharma companies.

6) Free access report link: "Cell Therapy Manufacturing: All Signs Point to Commercialization"
  • The recent report featured by Genetic Engineering & Biotechnology News details about new manufacturing technologies that enable the commercialization of cell therapies. Some new technologies detailed in the report include manufacturing automation, better enrichment techniques, GMP systems, and academic institution collaboration.

7) Free access report link: "Key Considerations Gen Therapy Manufacturing Commercialization"
  • A detailed report by Cell Culture Dish discusses the key factors to be considered by companies for the manufacturing and commercialization of cell therapies. The 38-pager report provides insights into the latest manufacturing techniques, regulatory framework, upstream-downstream manufacturing, operations scalability, manufacturing outsourcing, analytical technique selection, among others.

8) Free access report link: "Commercializing Cell and Gene Therapies"

9) Free access report link: "Cellular and genetic therapies push into the commercial arena"
  • This report by Pharmaceutical Commerce offers insights about the recent success of gene and cell therapies (GCT) launched by Novartis and Kite Pharma. Additionally, it points out that approvals for GCTs usually are given for drugs treating rare diseases. The high costs for GCTs make it challenging for working with insurance and logistics companies for the commercialization of therapy.

10) Free access report link: "CAR-T Cell Program Development: A Tale of Two Institutions"
  • A review article recently published by HOPA, details about the eight-steps for successfully commercializing Chimeric Antigen Receptor T-Cell therapy (CAR-T). The steps include patient selection, consultation services, cell collection, treatment scheduling, CAR-T cell infusion, post-infusion care, and regulatory reporting.

11) Free access report link: "Commercializing Gene Therapies"
  • The recent report featured by Genetic Engineering & Biotechnology News provides details about the commercialization strategy of a newly approved chimeric antigen receptor (CAR) T-cell therapy by Novartis. It talks about the care coordination, treatment monitoring, outcome measurement, and other high-touch services for the patients.

12) Free access report link: "Scaling up gene therapy to address global commercialization challenges"
  • The report by AvroBio highlights the challenges associated with scaling manufacturing and commercializing operations for cell and gene therapies.

13) Free access report link: "Forging a new path to commercialization for cell and gene therapies"
  • A report by Deloitte points out the necessary changes to be incorporated for manufacturing, commercializing, pricing, and reimbursement model for personalized therapies like GCTs.

14) Free access report link: "ISCT 2019 Commercialization Signature Series"

15) Free access report link: "Optimizing the Cell Collection Network to Support the Commercialization of Cell and Gene Therapies"
  • Another report by BioInsights details about the optimization of cell collection (raw materials) from patients for commercialization of GCTs. It presents an interview report of Amy Hines and Kimberly Kasow, discussing the challenges and capabilities of apheresis centers for handling patient samples.
Sources
Sources

From Part 01
From Part 02
From Part 03