The questions posed to the FDA during both the cell and gene town halls indicate that we are trying to better define “phase appropriate” development and understand where our material/vendor selection and qualification need to be more diligent. Despite the murkiness of this topic in general, there were a few best practices I took away from the FDA’s recommendations.
- 4 “Hot Takes” On Cell & Gene Therapy Manufacturing From Advanced Therapies Week 2023
- How Do Cell & Gene Therapy Requirements Differ Between FDA & EMA?
- The Promise Of Outcomes-Based Agreements For Cell & Gene Therapies
- The Holistic Guide To Supply Chain For Cell & Gene Therapy Startups
- EMA's Revised GMP Annex 1 Addresses Common Global Challenges for Sterile Products
- FDA Releases Final Guidance On Early-Phase Cell & Gene Therapy Trials
- Revision Of The ASTM E3263 Standard For Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues
- Defining The RNA Therapeutics Industry In 2023
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![iStock-1288116976-regulatory-compliance]( "Utilize Modular Cleanrooms To Reduce Your Risk Of An FDA Form 483 Violation")
Utilize Modular Cleanrooms To Reduce Your Risk Of An FDA Form 483 ViolationA cleanroom facility remains safe for your workers – and that the therapeutics they produce remain safe for patients - can ease your compliance concerns.
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![Gender equality womens rights GettyImages-1209252233]( "Women-Centric Approach To Clinical Trials")
Women-Centric Approach To Clinical TrialsWomen are demanding more power, information, and control when it comes to their health. Learn how women now have a stronger voice when it comes to clinical research for treatments that impact their care.
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![GettyImages-1267063597-lab-PPE-development]( "Considerations For Cell & Gene Therapy Clinical Development, Part 1")
Considerations For Cell & Gene Therapy Clinical Development, Part 1Part 1 of a 2-part series featuring C-suite leaders from advanced therapy companies at the American Society of Gene & Cell Therapy (ASGCT) 24th Annual Meeting.
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![GettyImages-175418592-lab]( "Biotech Enables Accelerated Scale-Up Of A Spray-Drying Program")
Biotech Enables Accelerated Scale-Up Of A Spray-Drying ProgramA virtual biotech, focused on the development and commercialization of a product to treat advanced solid tumors, partnered for the development, clinical trial supply, and scale-up of a spray-drying program.
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![AM STABTEST Waters Inc]( "A&M STABTEST Expands Service Offerings In Protein And Oligonucleotide Analysis With LC-MS System")
A&M STABTEST Expands Service Offerings In Protein And Oligonucleotide Analysis With LC-MS SystemCRO upgrades systems to provide regulatory compliance for large-molecule protein analysis, expanding their oligonucleotides capabilities.
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![Bio-Techne]( "A Multi-Antigen Serology Assay For COVID-19 Using Simple Western")
A Multi-Antigen Serology Assay For COVID-19 Using Simple WesternThe characterization of the human immune response to SARSCoV-2 is central to understanding COVID-19 disease progression and the efficacy of a vaccine. In this application note, we show how the SARS-CoV-2 Multi-Antigen Serology Module for Jess/Wes from ProteinSimple allows for simultaneous detection of human serum IgG reactivity with 5 viral antigens commonly associated with COVID-19. This kit provides a richer view into the immune response to SARS-CoV-2 in a single, quick, and easy assay.
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![iStock-1287056904-map-logistics-world-globe]( "The hMSC Standard In The Ivory Tower")
The hMSC Standard In The Ivory TowerWe accepted the challenge and built a business to enable a system of high quality and scalable volumes (billions) of human mesenchymal stromal cells (hMSC), paired media systems, and Good Manufacturing Practice (GMP) bioprocess expertise. But, did it work?
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![Gene Therapy-GettyImages-1302573302]( "Process And Communication: Navigating Logistical Complexity In Matched Cellular Therapy Trials")
Process And Communication: Navigating Logistical Complexity In Matched Cellular Therapy TrialsIn this case study, learn why ensuring that the site personnel and department processes are cohesive and able to accommodate the protocol-specific requirements is key to successful study execution.
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![Bio-Techne Fluorokines images]( "A Simple Flow Cytometry-Based Assay For Detecting CAR Expression")
A Simple Flow Cytometry-Based Assay For Detecting CAR ExpressionLearn more about fluorescent-labeled recombinant proteins that allow chimeric antigen receptors (CARs) to be directly stained and detected by flow cytometry.
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![GettyImages-1371706582-lab-computer-cell]( "Challenges And Solutions In Cell And Gene Therapy Manufacturing")
Challenges And Solutions In Cell And Gene Therapy ManufacturingDiscover the three major challenges cell and gene therapy manufacturers are facing today and experienced insights on how to overcome them.
NEWSLETTER ARCHIVE
CELL AND GENE LIVE
To achieve commercial success, a developed process must be scalable and suitable for a manufacturing environment. The scaling strategy depends on the type of cell therapy. Check out our latest Cell & Gene Live - now available On-Demand.
Cell & Gene Live ArchiveCELL AND GENE CONTENT COLLECTIONS
While both allogeneic and autologous therapies use similar technologies common to the growth of cells, the scale is different. In this e-book from Cell & Gene, we've curated insightful editorial that concentrates on the advancements of both allogeneic and autologous therapies and how to manufacture them at scale.
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