CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Building An Army: Cell Therapy Platforms With Dr. Helen Sabzevari, CEO Of Precigen

  Two of the biggest challenges facing the cell and gene therapy space today — controlling costs and optimizing scalability — have the potential to be addressed by companies through innovative, integrated technology solutions. In a recent episode of The Business of Biotech, Dr. Helen Sabzevari discussed how her company Precigen has used customized therapeutic and platform technologies to tackle scale-up in the CAR-T therapeutics space.

• Enhancing The Solubility Of L-Tyrosine In Cell Culture Media Applications

  Because L-Tyrosine is an important amino acid for protein synthesis and cellular metabolism, finding a solution to its solubility challenge can be critical to maximize process performance. 

• Blazar Platform: Rodent Virus Panel

  By amplifying multiple targets within a conserved region of the viral family genome, Blazar detects a much broader range of adventitious viruses as compared to traditional polymerase chain reaction methods.

• The Importance Of CDMO Capacity For Viral Vectors: A Conversation With Forge’s Dr. Timothy Miller

  In this episode of The Business of Biotech, Forge Biologics' Dr. Timothy Miller talks about the importance of increasing specialized CDMO capacity for cell and gene therapy applications.

• Robust Process Development For cGMP Manufacturing Of Cell Therapies

  By leveraging early decisions around process development, quality assurance, and quality control strategies, you can set yourself up for a successful cGMP manufacturing workflow. 

• GxP Validation In The Age Of Technology Disruption

  Drug development has dramatically changed over the past ten years. A practice once dominated by pen-and-paper has since been overrun by computerized systems, cloud software, and artificial intelligence. In this piece, we will chronicle recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.

• Bone Marrow-Derived Human Mesenchymal Stem Cell Production In HYPERStack® 36-layer Cell Culture Vessels

  Although Mesenchymal stem cells (MSCs) can be isolated from different tissue sources, bone marrow-derived MSCs are commonly studied due to their ease of access and achievable therapeutic dosage (2 x 10⁶ cells/kb of body weight). Here, we demonstrate the utility of the Corning HYPERStack 36-layer cell culture vessel as a tool to meet the growing demand for expanding bone marrow-derived MSCs to relevant scale for clinical application workflows.

• Best Practices for 21 CFR Part 11 And GxP Validation For Electronic Records

  Drug development has dramatically changed over the past ten years. A practice once dominated by pen-and-paper has since transitioned to computerized systems, cloud software, and artificial intelligence. This paper chronicles recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.

• Cell And Gene Therapy Definitions For Raw Materials, Starting Materials, Drug Substance And Drug Product

  The complexity of processes to manufacture cell and gene therapy medicinal products can cause confusion around definitions of raw materials, starting materials, process intermediates, drug substance and drug products. This document will discuss the definitions of the above process components.

• Multidimensional Analysis Of T Cell Cytotoxicity And Serial Killing

  To harness their full therapeutic potential, we must understand the relationship between target cell killing and other critical functions of individual T cells. Our platform can be used to interrogate antigen-specific serial killing activity of single CAR T cells and correlate this to cytokine secretion and proliferation while preserving individual T cells for downstream analyses or expansion.