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

• Total Transportation Management Saves Company $10.2 Million

  A leading multinational pharmaceutical company approached Fisher Clinical Services with an extensive clinical trial pipeline and the need to achieve a comprehensive, fully-managed transportation strategy. Learn more about our outsourced transportation option that delivered tangible results.

• Understanding And Controlling Raw Material Variation In Cell Culture Media

  An organized effort across biopharma, including drug substance manufacturers and suppliers, is needed to address and meet the needs of industry regarding raw material quality and consistency.

• Viral Clearance: The Basics On How To Conduct Effective Studies

  Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.

• R-Loops And Their Key Role In Cancer Research

  Understanding the conflicting nature of R loops and the challenges of balancing them to result in a positive effect.

• 6 Regulatory Changes Affecting Bioprocessing In China

  This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

• Intracellular Flow Cytometry Tips And Tricks

  Helpful tips such as carefully choosing the most suitable fixative and permeabilization reagents as well as other factors that should be considered when designing intracellular flow experiments.

• Practical Tips To Develop A Lentivirus Packaging Cell Line

  CAR T therapies are expensive, and  lentiviral vectors (LV) production represents a large portion of these costs. High manufacturing costs for LV are driven by low efficiencies from limited scalability in adherent cell culture, as well as requirements for large manufacturing spaces and several manual manipulations that increase labor costs. Following are practical tips and a case study to develop a lentivirus packaging cell line.

• Cell Therapy Manufacturing Under GMP - How And When To Get Started

  Emerging cellular therapies aim to manufacture cell populations for clinical indications, such as cancer, autoimmune, and cardiovascular diseases. As hospitals and translational facilities explore implementation of this technology they concurrently evaluate whether or not to manufacture the therapies onsite. Here is a guideline of how and when to get started.

• Cold-Chain Bioprocessing: Mitigate Risk, Protect Biopharma Products

  Many mAbs, vaccines, and other biotherapeutics must be reliably stored and transported at sub-zero temperatures, requiring a robust cold chain that continues throughout downstream processing. 

• How Supplier Evaluations, Component Neutrality Enhance Supply Chains

  When a new product, technology, or supplier is selected during the development and design phase of the biological manufacturing process, manufacturers must assess the supplier’s own supply chain and beyond.