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
Utilize Modular Cleanrooms To Reduce Your Risk Of An FDA Form 483 Violation
A cleanroom facility remains safe for your workers – and that the therapeutics they produce remain safe for patients - can ease your compliance concerns.
Women-Centric Approach To Clinical Trials
Women 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.
Considerations For Cell & Gene Therapy Clinical Development, Part 1
Part 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.
Biotech Enables Accelerated Scale-Up Of A Spray-Drying Program
A 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.
A&M STABTEST Expands Service Offerings In Protein And Oligonucleotide Analysis With LC-MS System
CRO upgrades systems to provide regulatory compliance for large-molecule protein analysis, expanding their oligonucleotides capabilities.
A Multi-Antigen Serology Assay For COVID-19 Using Simple Western
The 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.
The hMSC Standard In The Ivory Tower
We 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?
Process And Communication: Navigating Logistical Complexity In Matched Cellular Therapy Trials
In 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.
A Simple Flow Cytometry-Based Assay For Detecting CAR Expression
Learn more about fluorescent-labeled recombinant proteins that allow chimeric antigen receptors (CARs) to be directly stained and detected by flow cytometry.
Challenges And Solutions In Cell And Gene Therapy Manufacturing
Discover the three major challenges cell and gene therapy manufacturers are facing today and experienced insights on how to overcome them.
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 Archive
CELL 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.More Content Collections