Cell Therapy - Digital Technologies

Part
01
of three
Part
01

Research and Development

Some reports on the use of digital technologies to address challenges in research and development of cell therapy include R&D developments on new biomolecular platforms and digital technologies. Additional details on several reports on developments and research related to the use of digital technologies in addressing challenges in cell therapy are below.

Name: Developments in Automation Software for Cell Therapy

  • The report elaborates on how GE Healthcare is utilizing automation software to develop solutions for cell therapy is available via this link.
  • The report is available to the public for free.

Brief Description:

  • Chronicle "automation software is a GMP compliant" program fit-for-purpose digital solution for the optimization of "complex cell therapy process" developments and manufacturing.
  • The "my.Cryochain" software now supports the complete workflow of cell therapy. The solution depends on real-time supply chain tracking, performance monitoring for hardware, SMS or email alarms, as well as comprehensive electronic batch records.
  • Researchers at Vanderbilt University Medical Center reveals that "automation software provides" their lab with a digital stem cell processing solution which is flexible.

Name: Advances in R&D- New Biomolecular Platforms and Digital Technologies

  • The report on advances in R&D, new biomolecular platforms, and digital technologies is accessible via this link.
  • The report is available to the public for free.

Brief Description:

  • The report elaborates on the potential and developments of a disruptive technology obtained through the "intersection of automation, biology and digital technology" for the creation of a bright future in an area known as the pillar of "cell and gene therapy."

Name: Effect of Biomolecular Platforms and Digital Technologies on R&D in Gene Therapy

  • The report on the effect of biomolecular platforms and digital technologies on R&D in gene therapy is accessible via this link.
  • The report is available to the public; it is free of monetary charges.

Brief Description:

  • The report states that by embracing "digital technology," biotech pioneers encounter promising biomolecular platforms that are improving drug discovery and development as well as changing the pharmaceutical industry.
  • These platforms/technologies are yielding new treatments ranging from various DNA-, RNA- and "cell-based therapies" that have broad spectra of applications. These new interventions provide a glimmer of hope for the eventual treatment of life-threatening diseases that have defied conventional treatment approaches.

Name: Barriers to Cell and Gene Therapy Development for Rare Diseases — How to Overcome Them

  • The report on overcoming barriers to cell and gene therapy development is accessible via this link.
  • The report is available to the public for free.

Brief Description:

  • The report elaborates on how pharma and CROs can leverage increased use of "digital technology" for the execution of remote or highly fragmented multisite trials. This process makes trial participation much easier for patients and is vital in helping pharma companies overcome the barriers to "cell and gene therapy development" for rare diseases.

Name: The Engineers Captivating Pharma Produce Cells Not Software

  • The report on engineers captivating pharma with the production of cells, not software, is accessible via this link.
  • The report is available to the public for free.

Brief Description:

  • The report discussed how R&D leaders are leveraging data science and "digital technology" and placing their most substantive bets on innovations in biological technologies like "cell therapy."

Name: Use of Digital Technology in Somatic and Gene Therapy Trials among Pediatric Patients with Ocular Diseases

  • The report on the use of digital technology in somatic and gene therapy trials among pediatric patients with ocular diseases is accessible via this link.
  • The report is available to the public for free.

Brief Description:

  • The report covers the use of "digital technology" in somatic and gene therapy trials among pediatric patients with ocular diseases
  • The report alleges that genomics reshapes health systems. It also states that advancements in technologies enable the personalization and customization of healthcare delivery. However, there is insufficient evidence on the utilization and impact of genomics in somatic and gene therapy trials among children.
  • The review section of the report intends to shed light on evidence on digital technology applied to "genetic and somatic cell therapy" clinical trials among children with ocular diseases.

Name: Building The World's Most Comprehensive Advanced Therapies Ecosystem

  • The report on building the world's most comprehensive and advanced therapy's ecosystem is accessible via this link.
  • The report is available to the public for free.

Brief Description:

  • The report reveals that the CGT Catapult manufacturing center is helping Cell Medica to establish a cell therapy manufacturing system. Through this support, Cell Medica will have greater control over its manufacturing activities. This support involves setting up a purpose-built, cost-effective, and collaborative facility.
  • The report further reveals that next-generation manufacturing would require artificial intelligence (a digital technology). Artificial Intelligence (AI) will "produce cost-effective therapies at the scale necessary to meet clinical demand," and a revolutionary new approach is required. The use of AI could also ensure that gene-therapy products are accessible as well as affordable.

Name: Clinical Innovations for Combination Immunotherapy

  • The report on clinical innovations for combination immunotherapy is accessible via this link.
  • The report is available to the public for free.

Brief Description:

  • The Pharma Week report includes a speech given on the significance of leveraging "digital technology in a clinical trial" environments to differentiate therapy, provide quick insights, and provide patient-centric solutions. This referenced talk-show aims to discuss the steps necessary to move beyond current digital health "pilot-itis." It seeks to describe the ecosystem of functions as well as capabilities needed to scale the utilization of digital technologies for clinical operations.
  • The speech on "Digitalization of Clinical Trials in Immuno-Oncology" was made by Jill Loftiss, the head of Clinical Operations & Oncology, MedImmune, on Wednesday, June 19. Other speeches in the report relate to cell therapy but are not available to the public.

Name: Novartis Launches An App For Ophthalmology Research

  • The report on Novartis launching an app for research in ophthalmology is accessible via this link.
  • The complete report is available to the public for free.

Brief Description:

  • The report states that Novartis is the latest company that has moved to "embrace all things digital." It has launched an app to boost participation in ophthalmology clinical trials. The app promotes the implementation of CRISPR-based "cell therapy 2.0." The research project has a funding of $85 million.
  • The project is offering a 10-15% savings in terms of patient enrollment times for pilot trials

Name: Digital Technologies Can Aid Productivity and Growth

  • The report on how digital technologies can aid productivity and growth is accessible via this link.
  • The report is available to the public for free.

Brief Description:

  • The report credited to Bioprocess Development Forum reveals that "digital technologies" can improve productivity and drive growth in cell therapy manufacturing and bioprocessing. Through the application of remote monitoring solutions, advanced modeling, as well as the optimization of manufacturing processes, digitalization can improve process reliability and boost product quality by relying on the unlimited possibilities of connected machines and data. This process proves to be especially useful "in cell therapy manufacturing and distribution."

Name: Digital Technology in Somatic and Gene Therapy Trials

  • The report on the use of digital technology in somatic and gene therapy trials is accessible via this link.
  • The report is available to the public for free.

Brief Description:

  • The report outlines how healthcare information technology, as well as information and communication technology resources, can help promote somatics and gene therapy clinical trials among children with ocular diseases. The review enabled authors in the identification of challenges and provided some recommendations to facilitate the uptake of genetic therapies as "therapeutic tools in pediatric ophthalmology." The article elaborates on the strategic uses of gene and somatic cell therapies, respectively.

Name: Advances in Digital Technologies by Oslo Cancer Cluster

  • The report on advances made in digital technology in cancer treatment by Oslo Cancer Cluster is accessible via this link.
  • The report is available to the public for free.

Brief Description:

  • The report by Oslo Cancer Center discusses developments in the use of software (a digital technology solution) to identify neoantigen targets, and manufacture personalized cancer vaccines, implement cell therapies.
  • The report also discusses events surrounding the optimization of patient selection for cancer immunotherapy clinical trials. It also discusses the use of a digital platform, known as the Health Analytics Platform (HAP).
  • HAP is utilized in implementing biobanks to preserve biological samples for research. This process gives rise to a single point of easy access to data.
  • The report covers how AI keeps revolutionizing cancer research.

Name: ZhongAn Life Sciences Builds Laboratory with its Global Partner

  • The report on ZhongAn Life Sciences' Laboratory with its Global Partner is accessible via this link.
  • The report is available to the public for free.

Brief Description:

  • The report elaborates on the rapid development of life sciences through digital technology, along with technological breakthroughs such as gene sequencing and cell therapy.
  • It reports on the use of digital technologies, including cloud computing, big data, and artificial intelligence in the implementation of life sciences such as genetic testing, stem cells, and other technologies.

Name: French Health Tech Prepares for Global Competition

  • The report on the French health tech Preparing for global competition is accessible via this link.
  • The report is available to the public; it is free of monetary charges.

Brief Description:

  • The report is about a French Health Tech bringing together over 600 companies (most of them are startups) to explore the healthcare sector of the future. They are seeking to make advancements in the fields of biology (immunotherapy, cell therapy, DNA sequencing, and editing, and so on).
  • They are also making advances in equipment (surgical robots, medical imaging, diagnostic tools, nanotechnologies) and digital technology (big data, IoT, 3D printing).
  • The French company seeks to use digital technology (big data, IoT, and 3D printing), to prepare future problems in healthcare.

Name: Advances and Successes in R&D via Digital Technology

  • The report on advances and successes in R&D via digital technology is accessible via this link.
  • The report is available to the public for free.

Brief Description:

  • The study reveals that advances in science and technology continue to transform the healthcare sector and increase the probability of success in R&D.
  • A better knowledge of human biology and genetics has enabled scientists to identify as well as develop "novel, targeted treatments" and vaccines.
  • Digital technology, data, and analytics are improving therapeutic medicines and vaccines and enabling better measurement of their effectiveness. GSK's pipeline focuses on immuno-oncology, "cell therapy," and cancer epigenetics. Large-scale genetic resources, as well as "unique data science skills," have improved the probability of R&D success.

Name: Digital Therapeutics — The Need To Do Further Research for Your Patients

  • The report on digital therapeutics and further research for patients support are accessible via this link.
  • The report is available to the public; it is free of monetary charges.

Brief Description:

  • The study states that cell therapy is a miraculous technology. Digital therapeutics, as well as supply chains in life sciences, need to "be reimagined." By implication, there is a need for further research and development. Additional work on digital technologies will "enhance supply chain capabilities" to serve patients better.
  • Organizations need to take advantage of the disruption in life sciences by leveraging "digital technologies to architect an intelligent" supply chain, which is smart.

Name: Managing Biotechnology — From Science to Market in the Digital Age

  • The report on managing biotechnology — from its science to its market in the digital age is accessible on Google books via this link.
  • A copy of the book is available on Amazon behind a paywall. It is available on Amazon for $49.44.

Brief Description:

  • The article elaborates on managing biotechnology — from the science phase to the market in the digital age. It reveals that "digital evolutions in biotechnology" (digital R&D in biotech) affect several sectors positively. Some industries positively affected include gene and stem cell therapy, tissue engineering, as well as regenerative medicine.

18. Name: How Artificial Intelligence Effectively Assesses the Functionality of Cell Therapy

  • The report on how artificial intelligence effectively assesses the functionality of cell therapy is accessible via this link.
  • The report is available to the public; it is free of monetary charges.

Brief Description:

  • Artificial intelligence (a digital technology) can effectively assess the functionality of cell therapy.
  • According to the lead investigator (lead researcher) Nathan Hotaling, it is possible to classify cells with high accuracy utilizing "nothing but absorbance images." Nathan Hotaling has been working on absorbance images with colleagues at the National Institutes of Health.
  • Using multi-spectral absorbance images, they conducted a non-invasive, automated fast and robust procedure to assess "induced PSC maturity, function, and identity."

19. Name: Machine Learning for Cell Therapy

  • The report on machine learning for cell therapy is accessible via this link.
  • The report is available to the public; it is free of monetary charges.

Brief Description:

  • Gritstone Oncology, Inc recently announced a strategic collaboration to "develop cell therapies for cancer." This partnership was the first of its kind for bluebird bio and demonstrates faith in machine learning in product development.
  • The research and development partnership is seeking solutions for severe "genetic diseases like cerebral adrenoleukodystrophy and transfusion-dependent β-thalassemia," as well as also cancer.

20. Name: Proteona and AI Singapore — Partnership to Improve Cell Therapy and IO Treatments

  • The report on Proteona and AI Singapore's partnership to improve cell therapy is accessible via this link.
  • The report is available to the public; it is free of monetary charges.

Brief Description:

  • The report is on an "innovative AI-driven genomic" and proteomic analysis platform to improve cell therapy and immuno-oncology.
  • The innovation involves about 100 experiments on programs to develop AI tools on single-cell multi-omics data analysis. The project team includes Prof Wong Limsoon, Kwan Im Thong Hood Cho Temple Chair Professor from the National University of Singapore (NUS) School of Computing, a leading expert in bioinformatics and computational biology.

RESEARCH STRATEGY

The research reviewed reports on research and development efforts that have solved challenges related to cell therapy in the past. It also included ongoing efforts that rely on the use of digital technologies to address problems in research and development of cell therapy. Reports on the view of experts, their theories that are under implementation, and seminar presentations on solutions in cell therapy based on research and development are also in the study. The study includes several reports on digital technology, digital biotechnology, and artificial intelligence. It is assumed that artificial intelligence, machine learning, and digital biotechnologies are all various forms of digital technology.
Part
02
of three
Part
02

Manufacturing And Supply Chain

Fifteen reports on the use of digital technologies to address challenges in manufacturing and supply chain of cell therapy include academic reports such as "Enabling Technology For Scalable Manufacturing Of Cell Therapy Products" and "Streamlining cell therapy manufacturing: Automated production and integrated data management" as well as industry reports such as "Cell Therapy Market Research Report- Global Forecast till 2023".

1. Enabling Technology For Scalable Manufacturing Of Cell Therapy Products

  • The report titled "Enabling Technology For Scalable Manufacturing Of Cell Therapy Products" was published in January 2019, and addresses the challenges regarding PBS Vertical-WheelTM single-use bioreactors and ENABLE contract process development and scale up services for cell therapy customers.
  • It is a scientific free report that can be acquired by contacting the online library here.

2. Streamlining cell therapy manufacturing: Automated production and integrated data management

  • "Streamlining cell therapy manufacturing: Automated production and integrated data management" is an academic report published in January 2019 that addresses the 'Industry 4.0' framework when it comes to cell therapy manufacturing.
  • It is a scientific free report that can be acquired by contacting the online library here.

3. Commercial Scale Manufacturing of Allogeneic Cell Therapy

  • "Commercial Scale Manufacturing of Allogeneic Cell Therapy" is an academic report published in August 2018 that addresses the need for the use of technology in the commercial manufacturing of allogeneic cell therapy products.
  • It is a scientific free report that can be downloaded here.

4. Technologies for Cell and Gene Therapy Manufacturing

  • "Technologies for Cell and Gene Therapy Manufacturing" is an academic article produced as a summary of Cell and Gene Therapy Week, and was published in August 2019.
  • In the report, CAR-T cell-based gene therapy technology is discussed at length. The article can be found for free here.

5. Acoustic cell processing — An innovation in cell therapy manufacturing

  • "Acoustic cell processing — An innovation in cell therapy manufacturing" is an academic report published in January 2019 that addresses the new technology called Acoustic Cell Processing (ACP) which is "being applied to key steps in the cell therapy manufacturing process as discrete unit operations such as cell selection, transduction, and concentrate/wash."
  • It is a scientific free report that can be acquired by contacting the online library here.

6. Phacilitate Automation SIG: 2018 Report

  • "Phacilitate Automation SIG: 2018 Report" is a free industry report published by Phacilitate, an organization whose mission is to "unite the global advanced therapies community with investors in the capital."
  • The report tackles the latest innovations in cell therapy manufacturing, and can be accessed for free here.

7. An Integrated Digital Vision for Biomanufacturing’s Future

  • "An Integrated Digital Vision for Biomanufacturing’s Future" is a report published by Vivienne Raper, PhD, on the innovations in cell therapy when it comes to manufacturing practices, specifically for the last two years.
  • The report is free and can be found here.

8. Cell Therapy Manufacturing Market (2nd Edition), 2018 – 2030

  • "Cell Therapy Manufacturing Market (2nd Edition), 2018 – 2030" is a market report published by Roots Analysis that tackles multiple cell therapies, such as RECELL (Avita Medical) and YESCARTA (Gilead Sciences).
  • The report is behind a paywall ($3,499).

9. Cell and gene therapy GMP manufacturing in the UK

  • "Cell and gene therapy GMP manufacturing in the UK" is a market report published by CATAPULT that outlines the new advances in the UK regarding technological practices i cell therapy GMP manufacturing.
  • The report is free and can be found here.

10. Cell Therapy Market Size, Share, & Trends Analysis Report By Use (Clinical, Research), By Type (Stem & Non-stem Cells) By Therapy Type (Autologous, Allogenic), By Region, And Segment Forecasts, 2018 – 2025

  • "Cell Therapy Market Size, Share, & Trends Analysis Report By Use (Clinical, Research), By Type (Stem & Non-stem Cells) By Therapy Type (Autologous, Allogenic), By Region, And Segment Forecasts, 2018 – 2025" is an industry report published by Grand View Research.
  • The report is behind a paywall ($5,950) and gives detail into how technology is the driving force behind the manufacturing of cell therapy becoming a large and expansive market.

11. "Cell Therapy Market Research Report- Global Forecast till 2023"

  • The report titled "Cell Therapy Market Research Report- Global Forecast till 2023" was published in 2018 by Market Scenario, and explores technologies such as hematopoietic stem cells (HSC), mesenchymal stem cells, skeletal muscle stem cells, lymphocytes, pancreatic islet cells, and dendritic cells therapy which are being used for more successful manufacturing practices.
  • The report is behind a paywall ($4,450).

12. The Future of Tissue Engineering & Cell Therapy Markets to 2028

  • "The Future of Tissue Engineering & Cell Therapy Markets to 2028" is an industry report published in 2018 by Smithers which gives details about current technologies and innovations within the tissue engineering and cell therapy markets to 2028.
  • The report is behind a paywall ($4,500).

13. Advanced Therapies Investment Report

  • "Advanced Therapies Investment Report" by Biotech and Money is an industry report published in 2017, and it gives an overview of the technological advances made in the biotech industry, including the manufacturing challenges in cell therapy.
  • The report is free and can be found here.

14. Cell Therapy Technology Market

  • Cell Therapy Technology Market report is an industry report by Markets and Markets published in 2018.
  • In the report, it is stated that rising government investments for "cell-based research, the increasing number of GMP-certified production facilities, and the large number of oncology-oriented cell-based therapy clinical trials are the key factors driving the growth of this market."
  • The report is behind a paywall ($5,650).

15. Global Regenerative Medicine (RM) Market Report 2019

  • "Global Regenerative Medicine (RM) Market Report 2019" is an industry report published by Research and Markets in 2019.
  • In the report, the focus is on the manufacturing process for immunotherapy treatments, such as CAR-T cell therapies, most notably, Kymriah and Yescarta.
  • The report is behind a paywall ($4,000).
Part
03
of three
Part
03

Commercialization

The aim of this research was to find reports on the use of digital technologies to address challenges in the commercialization of cell therapy. Following are the details of the reports that were obtained from a search in relevant expert websites, websites of institutions and agencies in the field of medical technology and industry news websites.

"The Link Between Manufacturing and Commercialization in Gene and Cell Therapy"

"Manufacturing Cell Therapies: The Paradigm Shift in Health Care of This Century"

"Evolving Industry Partnerships and Investments in Cell and Gene Therapies"

"Achieving Efficient Manufacturing and Quality Assurance through Synthetic Cell Therapy Design"

"Advancing Medicine: Can cell and gene therapies paint a picture of perfect future health?"

"4 Emerging Commercialization Strategies For Gene And Cell Therapies"

"GE Healthcare unveils Chronicle to automate cell therapy manufacturing"

"CBMG Accelerates Cell Therapy Manufacturing with GE Healthcare's New Start-to-Finish Solution"

"What advances in manufacturing technology are most enabling the scale-up and commercialization of next-generation therapies?"

"Digital Technology in Somatic and Gene Therapy Trials of Pediatric Patients With Ocular Diseases: Protocol for a Scoping Review"

  • This is a report published by NCBI on February 7, 2019.
  • The report "identifies and examines digital technologies used to facilitate data analysis in somatic and gene therapy trials in pediatric patients with ocular diseases".

"Machine Learning for Cell Therapy"

"Advancing Cell and Gene Therapies"

"The future is digital: In silico tissue engineering"

  • This is a report published by ScienceDirect in June 2018
  • The report discusses Digital Twins, an aspect of the concept of Industry 4.0 which "refers to automation and data exchange in manufacturing technologies, and includes technologies for cell therapy product manufacturing".
  • The report is paywalled and can be purchased for $31.50.

"United States: View From The Horizon: Digital Health And Cell, Tissue, And Gene Therapies In Boston"

"The Dawn of Cell Therapies, Blockchain, and M&A: Industry Trends in the CMO Landscape"


Sources
Sources

From Part 01
From Part 02
From Part 03
Quotes
  • "The application of technology is a critical consideration in planning related to production time, scalability, and product purity and safety, as well as in expansion of target indications."
Quotes
  • "Recent advances in cell biology and genetic engineering have changed the way we think about medicine. Indeed, we are witnessing a potential shift from the traditional paradigm of health care to one with greater focus on the possibility of regenerative and curative treatments."
Quotes
  • "Cell and gene therapies hold the promise of bringing significant clinical benefits to patients by directly targeting the underlying cause of disease."
Quotes
  • "New methods to manipulate gene and cell state can be used to engineer cell functionality, simplify quality assessment, and enhance manufacturability."
Quotes
  • "The technology platforms of many of these drugs also offer the potential for curative efficacy and expansion for use in multiple indications."
Quotes
  • "“Chronicle automation software was designed to meet the digital needs of academic researchers and large biotechnology companies and will help ensure increased patient access to life-saving therapies,” Catarina Flyborg, general manager of cell and gene therapy for GE Healthcare, said in a statement."
  • "Flyborg explained the full potential of cell and gene therapies could not be realized without comprehensive digital solutions designed to optimize manufacturing processes, and which can also scale from process development to commercialization."
Quotes
  • "Through its collaboration with the Centre for Commercialization of Regenerative Medicine (CCRM), a leader in developing and commercializing regenerative medicine technologies and cell and gene therapies, GE Healthcare is providing CBMG with process development services."
  • "“CCRM and GE Healthcare established the Centre for Advanced Therapeutic Cell Technologies, or CATCT, to industrialize cell manufacturing and accelerate the efforts of companies working with cell and gene therapies."
Quotes
  • "Unlike what was once exclusively a batch process, with a multitude of limitations (inefficiencies, higher costs, higher risks of failed batches), drugs may now be produced in continuous manufacturing lines, coupled with precise monitoring through technologies like PAT (process analytical technology). It is important to note that a paradigm shift in manufacturing technology such as this will require manufacturers and suppliers to work side-by-side to design safe and effective processes."
Quotes
  • "we propose to conduct a review that will examine and identify the digital technologies used to facilitate data analysis in somatic and gene therapy trials in pediatric patients with ocular diseases"
Quotes
  • "To this end, Gritstone Oncology claims to have developed EDGE, an artificial intelligence platform trained on tumor data to better predict targets"
Quotes
  • "Digital, cloud-based solutions can greatly improve the safety — and speed — of the personalized medicine process. Systems such as Vineti allow for private and secure capture of critical patient data at each step in the value chain, such that each participant in the product journey can provide the right data at the right time to ensure product accuracy, safety and predictable product administration."
Quotes
  • "Digital health promises to bring digital technology into the health care arena, improving health and reducing costs. A key area of digital health innovation is the integration of digital health technology with pharmaceutical products."
Quotes
  • "At present, waiting times for CMOs to commence cell therapy manufacturing projects can be over one year (GlobalData, 2018a). The manufacture of viral vectors, which are commonly used for both cell and gene therapy products, has been a significant obstacle for cell therapy production speed due to its lack of scalability and cost-effectiveness, as well as quality issues and problems with process consistency. The growing cell therapy pipeline means that the process of viral vector manufacturing is in desperate need of improvement."