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.