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

31. Consistency And Compliance Through Cell Therapy Automation Software 4/30/2021

    As automation offers new options for flexibility and optimized production in biologic production, exploring its use in advanced therapy manufacturing to improve safety, quality, and compliance becomes a key factor in advancing patient care.

32. How Ramping Up Communications Helped Overcome A Next-To-Impossible Recruitment Challenge 4/21/2020

    We knew going in that it could be the perfect recruiting nightmare with extremely complex inclusion/exclusion criteria. By letting sites set their own goals and commit to them along with assigning project coordinators that stayed close to those sites the study is off to a good start.

33. Counting Murine CAR T Cells Using The Corning® Cell Counter 4/26/2021

    CAR T cells 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. This application note demonstrates the Corning Cell Counter offering an alternative method to quickly and accurately count these cells.

34. Cell Therapy Scale-Up Strategies For Commercial Success 9/30/2020

    This article discusses options for cell therapy process development and validation that minimize risks through quality control (QC), optimization, scaling, closing, automation, and assay development.

35. Optimizing Drug Safety And Efficacy Of Complex Next-Generation Biologics 9/11/2019

    Challenges exist when developing biologic drugs to be efficacious but safe. Novel analytical techniques, like surface plasmon resonance, can help circumvent these issues and optimize development.

36. CAR-T Cell Therapy: Novel Therapy With Great Potential 8/20/2020

    CAR-T cell therapy is a promising personalized approach in the treatment of acute or chronic leukemia. Find out more about the CAR therapy and its related chances and risks in this article.

37. Tangential Flow Filtration (UF/DF) Of Plasmid DNA 12/16/2020

    Due to their structure, plasmids can sometimes pass through pores that are smaller than their apparent molecular weight. Additionally, the DNA can be shear-sensitive and tends to increase with plasmid size, and the result can be degradation and reduction of the overall yield. Learn how optimization of hydraulic parameters can help you achieve the desired plasmid purity, formulation, and concentration specifications.

38. Automated High Throughput mAb Purification Using Fibro Technology 4/21/2020

    Read how the Fibro PrismA unit provides a time advantage with comparable recovery and product quality attributes to resin-based column.

39. Cleaning Up Patient Data … Quickly 3/2/2020

    A sponsor needed to deliver data so a go-/no-go decision could be made at a major internal meeting that couldn’t be rescheduled. The problems stemmed, in part, from a failure to communicate between a large, somewhat impersonal CRO and a small sponsor that was used to close personal relationships and more or less constant interaction with the team managing its studies. We picked up the project in March 2013 and completed data lock by the end of September.

40. Delivering Clinical Trial Medications Direct-To-Patient 10/15/2020

    In a perfect world, patients enrolled in clinical trials would live a short distance from the investigator site where they receive their treatment. Unfortunately, that is not always the case. In recent years, the direct-to- patient model, which brings medical procedures to a patient’s home, has emerged as a solution for sponsors to increase patient recruitment and retention in clinical trials.