In this article, part one of a two-part series, we explore the evolution of cell therapies of the innate immune system (such as γδ T and NK cells) to understand why these approaches offer great hope for oncology and the potential value they may offer second-generation cell therapy companies. Next week we will dive deeper into this burgeoning industry and the potential commercial impact these therapies may offer.
- U.S. Manufacturing On The Rise: Add Another CDMO To The Heartland
- Why Complex Disease Needs Gene Therapy
- An Analysis Of FDA’s Recently Issued Gene Therapy Guidances
- Part 2: Cell And Gene Therapy Is Transforming Healthcare
- Cell & Gene’s 2020 Outlook: Enzyvant, Spark Therapeutics, And Orchard Therapeutics
- Cell & Gene Therapy Deals: Emerging Trends To Watch
- Cell & Gene’s 2020 Outlook: Stem Cell Research
- Reflections On An Unprecedented Decade In The Cell And Gene Therapy Field
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
Industrializing Cell Therapy
As cell therapies continue to transition from the discovery stage to therapeutic reality, with further approvals sure to come, new challenges are emerging.
Avoid Costly Mistakes In Gene Therapy Process Development
Success in the evolving and highly competitive gene therapy space requires navigating many uncertainties related to process development and manufacturing of adeno-associated virus (AAV) and lentivirus vectors. These tips will guide development and manufacturing teams operating on compressed timelines.
Freezing Cellular Raw Materials For Cell Therapy Production
Key Biologics is harnessing new freezing technology to help deliver the future of medicine. Digitally enabled cryogenic cold chain technology can now deliver the raw materials needed to manufacture cellular therapies.
Complete Response: Lymphoma Trial A Success For Five Patients
A trans-Atlantic study to evaluate an antibody for treatment of B-cell non-Hodgkins lymphoma overcame patient recruiting challenges and has already succeeded beyond expectations in the form of five patients declared disease-free a year and counting while still three years from completing patient follow-up.
How A New Cell Therapy Platform Helps Scale Up Manufacturing To Reach More Patients
Cell therapy manufacturing has been a complex, challenging and costly process, but a new manufacturing solution seeks to change that
Case Studies In Supply Chain Management: Getting It Right From The Start
Consistent management and communication are the keys to success when managing the supply chain of any advanced therapy clinical trial. In this article, we’ll review two case studies that demonstrate the importance of supply chain management by focusing on scaling up for commercial distribution and on packaging challenges within a cryogenic environment.
Unifying Cell Therapy Logistics And Manufacturing
The supply chain and logistics for cell and gene therapies are especially critical to ensure the right patient gets the right treatment at the right time. Collaboration is the key to solving challenges such as data management and process variability, as stakeholders work towards a common goal—getting these life-saving treatments to the people who need them.
Reliable Single-Cell Sorting With Bio-Rad’s S3e ™ Cell Sorter
A demonstration of a simple workflow to verify the reliability of the S3e Cell Sorter in sorting single
cells. Using this method, a confirmed sorting accuracies of >94% and 100% for single cells and single beads is achieved, respectively.
Rapid, Sensitive Cancer Biomarker Screening In cfDNA
Multiplex digital PCR enables tracking of treatment efficacy using liquid biopsies.
Establishing Risk-Based Monitoring Within A Quality-Based System As “Best Practice” For Clinical Studies
This report based on a survey of ACRO members reveals that Risk-Based Monitoring (RBM) makes clinical trial quality review more efficient and effective. It found that when a company reviews data through a centralized system using the RBM model, CROs and technology companies are better able to detect quality issues earlier and make rapid corrections at the site level. This type of approach is now central to ensuring the safety of patients in clinical trials, and is expected to continue to grow in importance as clinical trials becomes more numerous and complex.
CELL AND GENE CONTENT COLLECTIONS
The cell and gene therapy sector’s focus on outsourcing is a major area of on-going concern due to the shortage of suitable manufacturing facilities and qualified outsourcing staff. This collection of original articles from Cell & Gene weighs the economic benefits of outsourcing (i.e. productivity, efficiency, time-to-market, and quality gains) as well as best practices for selecting an outsourcing partner.
More Content Collections
CELL & GENE INDUSTRY EVENTS
Remote Monitoring Operations While Maintaining HIPAA and GCP During COVID-19 Restrictions
April 2 - 2, 2020
1pm-2:30pm EDT, Online Training
Laboratory Data Integrity: Current Expectations for OOS Result Investigations
April 7 - 7, 2020
1:00 PM - 2:30 PM EDT
Medical Device Recalls – Keys To Implementing A Successful Approach
April 14 - 14, 2020
1pm-2:30pm EST, Online Training
Reacting to “Human Error” – Moving Beyond “Retraining” As A Response
April 15 - 15, 2020
1pm-2:30pm EDT, Online Training
Cleanroom Guangzhou Exhibition 2020
August 16 - 18, 2020