Cell And Gene Articles, App Notes, Case Studies, & White Papers

1. Meeting Quality Standards With Multiple Global Manufacturing Locations 8/25/2021

   With 66 global locations from Kansas to Krakow, Fagron needed a way to ensure each facility could stay in compliance with the regulations of every market they serve. The variety of processing by regulating authorities based on the country led to inconsistent processes. By implementing a software solution the team has reduced over 450 hours per year spent on preparing paper-based training materials, saving more than 500 sheets of paper per week at those sites.

2. Viral Quantification - AAV Vector Genome Titer Assay 10/13/2020

   Read how ddPCR represents a highly precise method to determine AAV vector genome titers and is not unduly influenced by inefficient amplification or standard curve issues.

3. Dermatology: The Changing Landscape Of Psoriasis Treatment 6/29/2021

   Over the past two decades, biologic therapies have revolutionized the treatment of psoriasis, with more than half of treated patients now able to achieve essentially complete clearing of their disease. Learn more about these therapies as well as new topical and oral therapies that are emerging.

4. How To Build A Robust Packaging Strategy For Rapid Commercialization 8/3/2021

   Look at the elements involved in building a robust packaging strategy and the key technical considerations in packaging design and operational planning for products of various sizes.

5. The Value Of Gene Therapy In Spinal Muscular Atrophy 3/11/2021

   A client was developing a potentially curative gene therapy, they needed to translate the clinical benefit into economic terms to engage payers and health technology organizations. By working with the client to develop a cost-effectiveness and budget impact model for a gene therapy in SMA that overcame unique challenges of modeling an early childhood neuromuscular genetic disorder they were able to change the prevailing mindset on how SMA progression is characterized.

6. Guide To Transitioning Clinical Cell Therapy Manufacturing To Commercial Scale 9/13/2021

   More and more CGT manufacturers are focusing on automating and closing unit processes earlier in the developmental cycle. This saves significant time, increases efficiency and reduces cost. In this paper, we discuss the automation strategies that CGT manufacturers should consider during this transition. We also provide a manufacturing roadmap that can improve manufacturing efficiencies along the developmental journey.

7. Purifying Infectious Virus Particles Using ÄKTA™ Start 5/20/2021

   This application note demonstrates a chromatography method for purifying reovirus RNA virus particles using a benchtop chromatography system, HiTrap brand columns, and Capto brand Core 700 resin.

8. Optimizing Site Readiness in Cell Therapy Clinical Trials Through Comprehensive Support 2/16/2021

   Providing comprehensive support to sites is a critical factor for cell therapy clinical trial success. 

9. Stabilizing Virus With Albumin To Improve Yield 5/27/2021

   During the cell culture process, the use of serum-derived proteins can drive heterogeneity of culture performance, increase the risk of introducing adventitious agents into the production system, and potentially jeopardize the availability of vaccines due to variable supply. In this paper a general protocol is described for the addition of recombinant albumin, in the form of the product Exbumin, to virus production systems to stabilize infectious particles and thereby maximize viral yield.

10. SARS-CoV-2 Viral RNA Extraction From Human Saliva Samples With NAB Nanosep® Centrifugal Devices 9/13/2021

    In this study we evaluate the performance of the Pall NAB Nanosep centrifugal device for the isolation of SARS-CoV-2 viral RNA from human saliva samples spiked with heat inactivated virus using reagents (RCOM1 and RCOM2) from two commercially available kits for extraction of viral RNA.