INSIGHTS ON CELL & GENE THERAPY DISCOVERY

• The Benefits Of Streamlining And Standardizing Plasmid DNA For Cell And Gene Therapies

  The need for greater volumes of high-quality raw materials like plasmid DNA in the cell and gene therapy space has made pDNA standardization integral to streamlining the development process.

• Cell Culture Process Development For AAV Vector Production In Suspension Cells

  Review experiments for the adaptation of HEK293 suspension cell line for transient transfection and scalable adeno-associated virus (AAV) production. The experiments reveal information on cell growth by population doubling time, morphology, and viability necessary.

• Streamlining Regulatory Submissions For A Novel Advanced Therapy Medicinal Product Trial

  The European regulatory landscape for advanced therapy medicinal products (ATMPs) is complex, and the approval pathway depends on product classification. This case study describes how product classification may not always be clear-cut, given the proliferation of novel approaches to ATMP development.

• Capture Of Histidine-Tagged Molecules Using Biacore His Capture Kit

  Find recommendations for immobilization of histidine-tagged molecules (ligands) by capture to an anti-histidine antibody covalently coupled to a sensor chip surface.

• A Changing World In Gene Therapy Research: Exciting Opportunities For Medical Advancement And Biosafety Challenges

  In this report, key developments are highlighted in the field with a focus on biosafety and provides guidance for performing risk assessments on the currently approved gene therapy products as well as the most utilized types of investigational products in clinical trials.

• Navigating Analytical Requirements For GMP Viral Vectors

  The keys to success are establishing appropriate strategies and fundamental testing, expecting additional regulatory requests, preparing for assay variability, and ensuring that comparability studies will be possible by retaining material from preclinical batch runs and stability studies.

• A Primer On Cancer Immunotherapy Part 2: The Cancer Immune Response & Mechanisms Of Resistance

  This article examines the rationale for combination therapies, mechanisms of resistance, and where to go from here.

• Analysis Of Cancer Spheroids Through High-Throughput Screening Assays

  In recent years, tumor-derived spheroids have been utilized to optimize cancer therapeutics for ovarian and hepatocellular carcinoma. However, there are some challenges to using spheroids for drug screening. Here we outline different kinds of high-throughput screening (HTS) assays that can be performed on cancer spheroids to assess drug response. We also provide some useful guidelines for handling spheroids and acquiring data to get the most meaningful results.

• Increase Drug Discovery Productivity, Optimize SPR Data Interpretation

  The need to increase efficiency and productivity has led scientists to develop a machine learning solution that can optimize the way that developers analyze and characterize their early drug candidates.

• A Primer On Cancer Immunotherapy Part 1: Goals And Major Approaches

  This post provides an introduction to cancer immunotherapy, exploring its immunological basis and the fundamental principles guiding the development of new treatments.