Researchers from Dyno Therapeutics (MA, USA) and Harvard University (MA, USA) have reported a comprehensive machine-guided approach to produce improved adeno-associated virus capsids for gene therapy delivery.
Browsing: gene therapy
Find out what regulatory recommendations exist for bioanalytical support of adeno-associated virus gene therapy development in this Bioanalysis article giving an overview of the current regulatory recommendations as found in FDA and EMA guidance documents.
As part of our mini-Spotlight on cell and gene therapies, we carried out a survey to gain an insight into the trends, challenges and developments associated with these fields – find out the results in this informative infographic.
Arno Kromminga and Lydia Michaut will discuss the strategies and challenges of immunogenicity assessment for gene therapy compounds.
Find out more about the challenges associated with gene therapy and what the future may hold for the field in this interview with Hugh Davis (Frontage Laboratories; PA, USA).
With the reality of Brexit already impacting the UK’s clinical trials environment, Zamas Lam (QPS; DE, USA) discusses the effect this will have on bioanalytical research, and suggests 10 questions to ask when relocating UK-based preclinical and bioanalysis research projects.
In this free on demand panel discussion, our experts provide insights into their own research with cellular and gene therapies including the challenges they have had to overcome, key trends they have seen and their future outlook of the development of this field.
To kick-start this special focus, we wanted to hear your thoughts on the topic – complete our short survey on cellular and gene therapy to be the first to receive our informative infographic collated from the survey results.
Challenges and opportunities in bioanalytical support for gene therapy medicinal product development
This review article from Bioanalysis> summarizes recent practices and considerations in bioanalytical support of pharmacokinetics and pharmacodynamics evaluations in gene therapy development with insight into method design, development and validations.
2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 – LBA/cell-based assays: immunogenicity, biomarkers and PK assays)
This part of the 2018 White Paper published in Bioanalysis covers the recommendations for large molecule bioanalysis, biomarkers and immunogenicity using LBA and cell-based assays.