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

• 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.

• Keys To Successful Risk Management In Clinical Trials

  Effective risk management recognizes variables unique to each clinical trial while embracing consistent documentation practices, stakeholder responsibility, and best practices informed by experience.

• Rapid Sterility Testing: Viral And Gene Therapy Applications

  For most cell and gene therapy products, a 14-day testing period for sterility is too long and hinders the timely release of products with a short shelf life or a small window for release to the clinic. Download this white paper to learn how validated, rapid sterility methods better address the needs of cell and gene therapy clients, with faster turnaround and increased throughput.

• Osmolality Is A Predictor For Model-Based Real Time Monitoring Of Concentration In Protein Chromatography

  The bottleneck for real time control and real time release is lack of product-specific in-line sensors or fast at-line
  methods suitable for model-based prediction of process outcome. Learn how osmolality as an at-line method is an excellent predictor together with UV280 and UV260 for protein quantity in model-based prediction using partial least squares methodology.

• Enabling Fast, Appropriate Drug Product Supply For Phase 1 Clinical Trials

  Without the ability to move smoothly from lab concept to manufacture to delivery of GMP clinical supplies to patients, critical milestones could be missed, delaying funding commitments from investors.

• Counting Peripheral Blood Mononuclear Cells Using The Corning® Cell Counter

  Peripheral Blood Mononuclear Cells (PMBCs) are often counted using time-consuming manual methods such as a hemocytometer. While the hemocytometer has been considered the gold standard for cell counting since the 18th century, results are frequently subjective, variable, and small differences in cell diameters cannot easily or reproducibly be discerned. The Corning Cell Counter offers an alternative method to quickly and accurately count these cells.

• Anticipating The Next Decade Of Gene Therapy

  With more and more organizations looking to pursue gene therapies for a range of indications, there remain a number of barriers to entry. However, the next decade will bring improvements across existing gene therapy modalities, including the development of alternative approaches to gene delivery, and advances in upstream and downstream processing, analytical methods and intensified/continuous processing.

• Navigating The CAR T-Cell Therapy Landscape To Develop Market Access And Distribution Strategies

  A client was preparing for the US launch of a CAR T-cell therapy into a new, rapidly evolving, and highly competitive market. In order to move forward they needed assistance assessing the current landscape and gathering relevant inputs needed for access and distribution strategy development.

• The Insource Vs. Outsource Dilemma

  Prior to making critical capacity decisions, a small biotech company completed an economic evaluation of manufacturing options to ensure it was selecting the best strategy for its manufacturing. Discover the critical elements of this analysis that may help to balance your assessment.

• Particle Size Analysis Overview

  This paper is intended to help those new to particle size analysis understand each technique’s various strengths and weaknesses in order to select the proper technique for their samples.