When a third line refractory patient is waiting for an autologous therapy to be developed, the stakes are literally life or death. Most cell therapy manufacturers use equipment developed for research, which introduces inefficiencies into larger-scale cellular bioprocessing. As a result, patients must wait several days or longer for their therapies to be prepared. In some 70% of cases, thats time patients dont have.
Draper, a not-for-profit research and development organization, is speeding the process with new tools designed specifically to produce cell therapies at scale. This equipment helps developers increase throughput and decrease costs, which not only makes therapies more available and more affordable, but also helps scientists push their research to its limits. Both autologous and allogeneic cell therapy products are in Drapers sights.
Weve talked with more than 60 therapeutic companies to identify their pain points and have developed modules to address them, Jenna Balestrini, head of strategy and business development for precision medicine and cell bioprocessing at Draper, told BioSpace.
A major concern we are hearing is the pain of single manufacturing sources, along with difficulty scaling, and dependence upon particular reagents. We want to create devices where the cell therapy developer chooses everything that goes into the process.
Were coming up with better solutions including hardware and automation to revolutionize how cell therapies are made, she continued. That means using precision engineering to make better cell therapies at scale. Specifically, Draper is reducing the handling steps, and removing magnetic bead separation, and eliminating the need for cell activation.
Physics, rather than biochemistry, plays a large role in the advancements. Balestrini said physics gives the power of flexibility.
Drapers recently-announced strategic technology collaboration with Kite, a Gilead Company, offers a good example of how reliance upon physics supports innovation. To improve Kites production of next-generation cell therapy products, beginning with its CAR T program, Draper is customizing four different modules:
This is a 22-month program, Balestrini said, so we expect to have clinical systems near the end of that period.
These advances help solve a significant challenge within the entire cell therapy industry.
Cell therapies today are expensive and hard to make, and they have long manufacturing times, Balestrini said. Thats largely because manufacturers are using equipment designed in the 1980s for an entirely different purpose general blood processing.
Magnetic bead separation is a good example, she said.
We often hear folks in the industry say they are losing between 40% and 60% of the product in the cell retrieval step, so theyre starting from a loss, Balestrini said. That can be a serious problem when they have a patient with few T-cells to start with. There are a lot of manual steps too, and labor in these processes is very expensive. Magnetic bead separation and downstream processing is often more of an art than a scalable manufacturing process.
Art, almost by definition, is inefficient.
Then, she continued, after all that processing you still need to insert a gene or series of genes, typically using either a viral vector or electroporation (which was initially a microbacterial research tool). Each process calls for precision engineering and control of the microenvironment, which may be unachievable using systems designed for other purposes. As each step increases losses, expansion times to get the patient the dose also increase.
The problem, aside from the expense and the delay in delivering a therapy, is that scientists have to keep the cells in culture longer typically in petri dishes that are not giving appropriate physiological cues. These long preparation times could reduce the therapeutic potential of the cell therapy.
As cell therapies mature, there will be a large, growing need for greater efficiency. But, because these therapies often are patient specific, the unmet need for better manufacturing solutions is large.
The technologies Draper is customizing for Kite are platform technologies that can be deployed in multiple applications.
We are talking with groups that are looking to leverage cell therapy for new or different indications, such as stem cell differentiation, sickle cell treatment and to treat autoimmune diseases, she said.
Draper has a history of developing manufacturing advances that allow scientific breakthrough to be translated to the clinic and broad commercialization. It is well-known for its work in precision microfluidics, gene delivery, integrated sensing, customization and automation.
For the cell therapy industry, Drapers innovations are a big step towards meeting the production improvements desired by the FDA, even after some therapies have been approved. By increasing production efficiency, therapeutics could become more affordable for payers and patients, and thus more widely prescribed.
Go here to read the rest:
- Individualized brain cell grafts reverse Parkinson's symptoms in monkeys - University of Wisconsin-Madison - March 3rd, 2021
- New Controversy for Stem Cell Therapy That Repairs Spinal Cords - The Great Courses Daily News - March 3rd, 2021
- Cell Therapy Company Raises $160 Million to Advance iPSC-Derived Therapies to Clinic - BioSpace - March 3rd, 2021
- NSAIDs to Treat Arthritic Canines Through 2028; Stem Cell Therapies to Invigorate Canine Arthritis T - PharmiWeb.com - March 3rd, 2021
- A region within GLI1 gene could potentially be targeted as cancer treatment - News-Medical.Net - March 3rd, 2021
- Magenta Therapeutics Reports Fourth Quarter and Full-Year 2020 Financial Results and Recent Program Highlights - Galveston County Daily News - March 3rd, 2021
- Global Animal Stem Cell Therapy Market 2020 2025 Research Report Segment Outlook, Growth Potentials and Analysis of COVID-19 Worldwide Outbreak KSU... - March 3rd, 2021
- Global Autologous stem cell and Non-stem cell based Therapies Market- Industry Analysis, Growth, Segmentation and Forecast-2019-2027 - The Bisouv... - March 3rd, 2021
- Stem Cell manufacturing Market Witness an Outstanding Growth and Strong Revenue and Forecast 2027 KSU | The Sentinel Newspaper - KSU | The Sentinel... - March 3rd, 2021
- New study launches into COVID-19 vaccine responses in patients with impaired immune systems - University of Birmingham - March 3rd, 2021
- U. Cancer Center pilot projects: investigating cancer connections - The Brown Daily Herald - March 3rd, 2021
- Animal Stem Cell Therapy Market Size 2021 | Global Trends, Business Overview, Challenges, Opportunities and Forecast to 2027 The Bisouv Network - The... - March 1st, 2021
- Human Lung and Brain Organoids Respond Differently to SARS-CoV-2 Infection in Lab Tests - UC San Diego Health - March 1st, 2021
- Contemporary Critical Care Complications of Stem Cell Transplant/Cellular Therapies - TMC News - Texas Medical Center News - March 1st, 2021
- Global Human Embryonic Stem Cells Market Size-Share Analysis and System Production | Addressing the Potential Impact of COVID-19 Top Companies FLA... - February 21st, 2021
- Studies Show ApoE4 Carriers Appear More Susceptible to COVID-19Experts Say the Jury Is Still Out - Being Patient - February 21st, 2021
- Global Stem Cell Therapy Market 2020 | Demand and Scope with Outlook, Business Strategies, Challenges and Forecasts to 2025 KSU | The Sentinel... - February 19th, 2021
- Associating Baseline PROs and Complications of Stem Cell Transplant - MedPage Today - February 19th, 2021
- USC scientist Ya-Wen Chen receives American Lung Association grant to advance stem cell-based lung therapies - USC News - February 10th, 2021
- Gamida Cell Presents Efficacy and Safety Results of Phase 3 Study of Omidubicel in Patients with Hematologic Malignancies at the 2021 TCT Meetings of... - February 10th, 2021
- Magenta Therapeutics to Present Additional Data from Phase 1 MGTA-145 Stem Cell Mobilization Program and Preclinical Updates on Targeting Conditioning... - February 10th, 2021
- Creative Bioarray Offers Stem Cell Lines Generation Service for Promoting Scientific Research - Press Release - Digital Journal - February 10th, 2021
- Stem Cell Therapy Market Revenue, Key Players, Supply-Demand, Investment Feasibility and Forecast By 2029: Osiris Therapeutics, NuVasive, Chiesi... - February 10th, 2021
- The International Parkinson and Movement Disorder Society (MDS) Continues to Caution Against Unproven Cell-Based Therapies for Parkinson's Disease -... - February 10th, 2021
- Global Stem Cell Partnering Terms and Agreements Directory 2020: Company AZ, Headline Value, Stage of Development at Signing, Deal Component Type,... - February 10th, 2021
- Money on the Move: January 27 February 2 - BioSpace - February 3rd, 2021
- Stem Cell Study Illuminates the Cause of a Devastating Inherited Heart Disorder - Newswise - February 2nd, 2021
- Experts Predict the Hottest Life Science Tech in 2021 and Beyond - The Scientist - February 2nd, 2021
- Global Apoptosis Assays Market Report 2020: Apoptosis Assay Kits Lead the Demand with 42.5% Share - Forecast to 2026 - GlobeNewswire - February 2nd, 2021
- Choroideremia Research Foundation Supports New Research to Expand Knowledge of This Rare Inherited Retinal Disease - PRNewswire - February 2nd, 2021
- APOE Tied to Increased Susceptibility to SARS-CoV-2 | ALZFORUM - Alzforum - February 2nd, 2021
- Stem Cell Research & Therapy | Home page - January 28th, 2021
- Stem cell - Wikipedia - January 28th, 2021
- stem cell | Definition, Types, Uses, Research, & Facts ... - January 28th, 2021
- Researchers use patients' cells to test gene therapy for rare eye disease - National Institutes of Health - January 28th, 2021
- Cooperation, appropriation, and vaccines relying on fetal ... - January 28th, 2021
- Stem Cell Manufacturing includes Attractiveness and Raw Material Analysis and Competitor Position Grid Analysis to 2027 | Merck KGaA, Thermo Fisher... - January 28th, 2021
- Cell Expansion Supporting Equipment Market Research Report 2020 key Insights Based on Product Type, End-use and Regional Demand Till 2027 | Beckman... - January 28th, 2021
- Global Cord Blood Stem Cells Market : Industry Analysis and Forecast (2019-2026) by Type, Application, and Region NeighborWebSJ - NeighborWebSJ - January 26th, 2021
- Animal Stem Cell Therapy Market to witness high growth in near future - Fractovia News - January 26th, 2021
- Groundbreaking Treatment for Severe COVID-19 Using Stem Cells It's Like Smart Bomb Technology in the Lung - SciTechDaily - January 6th, 2021
- Development Of New Stem Cell Type May Lead To Advances In Regenerative Medicine - Anti Aging News - January 6th, 2021
- Global Induced Pluripotent Stem Cells (iPSCs) Market 2020-2025 Business Insights and Sustainable Growth in Respective Industry - LionLowdown - January 6th, 2021
- Chronic Kidney Disease (CKD) Drugs Market: Increasing Burden of Kidney Disease is Expected to Drive the Market - BioSpace - January 6th, 2021
- Global Circulating Tumor Cells and Cancer Stem Cells Market To Reach A New Threshold of Growth By 2026 - The Courier - January 6th, 2021
- RNA molecules are masters of their own destiny - MIT News - January 6th, 2021
- Stem Cell Therapy Market Analysis, COVID-19 Impact,Outlook, Opportunities, Size, Share Forecast and Supply Demand 2021-2025 - Farming Sector - January 4th, 2021
- How brain inflammation and healing is pointing to new glioblastoma targets - FierceBiotech - January 4th, 2021
- Discover the Global Stem Cell Banking Market Opportunities, Key Manufacturers and Outlook - The Courier - December 30th, 2020
- Impacts of COVID 19 on Stem Cell Therapy Market 2020 Size, Demand, Opportunities & Forecast To 2026 - Factory Gate - December 30th, 2020
- Nociceptive neurons shown to boost hematopoiesis | 2020-12-28 - BioWorld Online - December 28th, 2020
- Global Stem Cell Therapy Market Growth Graph To Demonstrate Inclination Towards Positive Axis By 2026 - The Courier - December 28th, 2020
- Stem cells from cord blood can now be used across many conditions: Mayur Abhaya, MD & CEO, LifeCell Internat.. - ETHealthworld.com - December 28th, 2020
- Stem Cell Therapy Market (COVID-19 Analysis) 2020-2025 Is Booming Worldwide with Comprehensive Study Explores Huge Revenue Scope in Future - Farming... - December 28th, 2020
- Stem Cell Therapy Market Size 2020 | Opportunities, Regional Overview, Top Leaders, Revenue and Forecast to 2025 - LionLowdown - December 28th, 2020
- Autologous Stem Cell & Non-Stem Cell Based Therapies Market Research Report - Global Forecast to 2025 - Cumulative Impact of COVID-19 - Yahoo... - December 27th, 2020
- Global Adipose Stem Cells (ASCS) Market 2020 Global Insights and Technology Advancement, Trends, Opportunities and Forecast to 2027 - Factory Gate - December 27th, 2020
- Creative Medical Technology Holdings Announces Successful Application of ImmCelz Immunotherapy for Treatment of Stroke - PRNewswire - December 17th, 2020
- Global NK Cell Therapy and Stem Cell Therapy Market: Development, Current Analysis and Estimated Forecast to 2025 - The Courier - December 17th, 2020
- I Peace, Inc. and Avery Therapeutics announce collaboration to bring iPSC derived cell therapy for heart failure to the clinic - PRNewswire - December 17th, 2020
- Stem Cell Exosomes Market: Increasing advanced applications of exosomes is expected to drive the market - BioSpace - December 17th, 2020
- Creative Medical Technology Stock Price Increased 80.77%: Why It Happened - Pulse 2.0 - December 17th, 2020
- 1st Patients To Get CRISPR Gene-Editing Treatment Continue To Thrive - NPR - December 17th, 2020
- California's Proposition 14: short in the arm for stem cell research - BioNews - December 15th, 2020
- Networks of genes involved in congenital heart disease revealed - News-Medical.net - December 15th, 2020
- Researchers Discover Clue to How to Protect Neurons and Encourage Their Growth - UC San Diego Health - December 15th, 2020
- COVID-19 vaccine shows the long-term value of curiosity-driven basic research - News-Medical.Net - December 15th, 2020
- Global Cancer Stem Cells Market to Boost with CAGR of 11.8% and Cross a Margin of $1,898.3 Million During the Covid-19 Outbreak Exclusive Report [150... - December 10th, 2020
- City of Hope Doctors Present Innovative Therapies to Better Treat Blood Cancers at American Society of Hematology Virtual Conference - BioSpace - December 10th, 2020
- Procyon Technologies LLC and Novo Nordisk A/S to Collaborate on the Development of a Stem-Cell Based Therapy for Type 1 Diabetes - PRNewswire - December 10th, 2020
- Better education needed to give patients improved understanding of gene therapies, new review highlights - University of Birmingham - December 10th, 2020
- Extended Virus Shedding After COVID in Some Patients With Cancer - Medscape - December 10th, 2020
- Jasper Therapeutics Announces Data from First Transplant-naive Patient in Phase 1 Clinical Trial of JSP191 as Conditioning Agent in Patients with SCID... - December 10th, 2020
- How do you donate stem cells? Donating cells can help treat cancer, blindness and other conditions - heres how - The Scotsman - December 6th, 2020
- Free radicals may be important for the brain to remain adaptable - News-Medical.Net - December 6th, 2020
- New Cedars-Sinai Biomanufacturing Center to Spur Cell Therapies - Newswise - December 6th, 2020
- Worldwide Stem Cell Therapy Market Insights to 2025 - Analysis and Forecasts - GlobeNewswire - December 6th, 2020
- Gene therapy gives man with sickle cell disease the chance for a better future - UCLA Newsroom - December 6th, 2020
- UCLA receives $7.3 million grant to build state-of-the-art facility for developing gene, cell therapies - UCLA Newsroom - December 6th, 2020
- Anatomy of a vaccine: What it takes to create a safe, effective COVID shot - University of California - December 6th, 2020