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Ariadne Solutions
Pharmaceutical Technical Exchange Association Annual Conference
/ Events / 0 commentsRead moreIn April 2022, we discussed the role of molecular testing platforms, such as qPCR, ddPCR and NGS in enabling discovery and development of cell and gene therapy products. These technologies were recently introduced to bioanalysis of cell and gene therapy products, resulting in many unanswered questions on the appropriate use of these technologies in the field of bioanalysis, especially due to the lack of prescriptive guidance. We will use a redacted and anonymized qPCR case study to answer some of the questions that frequently come up.
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Ariadne Solutions
Virtual Training: Mitigating Immunogenicity Risk
/ Events / 0 commentsRead moreIn April 2022, we discussed the role of molecular testing platforms, such as qPCR, ddPCR and NGS in enabling discovery and development of cell and gene therapy products. These technologies were recently introduced to bioanalysis of cell and gene therapy products, resulting in many unanswered questions on the appropriate use of these technologies in the field of bioanalysis, especially due to the lack of prescriptive guidance. We will use a redacted and anonymized qPCR case study to answer some of the questions that frequently come up.
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Ariadne Solutions
2023 AAPS PharmSci 360
/ Events / 0 commentsRead moreIn April 2022, we discussed the role of molecular testing platforms, such as qPCR, ddPCR and NGS in enabling discovery and development of cell and gene therapy products. These technologies were recently introduced to bioanalysis of cell and gene therapy products, resulting in many unanswered questions on the appropriate use of these technologies in the field of bioanalysis, especially due to the lack of prescriptive guidance. We will use a redacted and anonymized qPCR case study to answer some of the questions that frequently come up.
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Ariadne Solutions
BioData Solutions announces new incorporation of Ariadne Software
/ News / 0 commentsRead moreAriadne Software® is committed to maintaining the highest levels of security and data integrity for its customers. On this journey of security and compliance, Ariadne has reached another milestone of ISO/IEC 27001:2013 certification for its information security management system. The ISO 27001 guidance is designed to ensure confidentiality, integrity, and availability of an organization’s and its customers’ data by investing in its people, processes, and technologies.
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Ariadne Solutions
17th WRIB (Workshop on Recent Issues in Bioanalysis) 2023
/ Events / 0 commentsRead moreIn April 2022, we discussed the role of molecular testing platforms, such as qPCR, ddPCR and NGS in enabling discovery and development of cell and gene therapy products. These technologies were recently introduced to bioanalysis of cell and gene therapy products, resulting in many unanswered questions on the appropriate use of these technologies in the field of bioanalysis, especially due to the lack of prescriptive guidance. We will use a redacted and anonymized qPCR case study to answer some of the questions that frequently come up.
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Ariadne Solutions
CRO Symposium: Exploring The Contract Research Industry & Market
/ Events / 0 commentsRead moreIn April 2022, we discussed the role of molecular testing platforms, such as qPCR, ddPCR and NGS in enabling discovery and development of cell and gene therapy products. These technologies were recently introduced to bioanalysis of cell and gene therapy products, resulting in many unanswered questions on the appropriate use of these technologies in the field of bioanalysis, especially due to the lack of prescriptive guidance. We will use a redacted and anonymized qPCR case study to answer some of the questions that frequently come up.
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Ariadne Solutions
AAPS National Biotechnology Conference (NBC) 2023
/ Events / 0 commentsRead moreIn April 2022, we discussed the role of molecular testing platforms, such as qPCR, ddPCR and NGS in enabling discovery and development of cell and gene therapy products. These technologies were recently introduced to bioanalysis of cell and gene therapy products, resulting in many unanswered questions on the appropriate use of these technologies in the field of bioanalysis, especially due to the lack of prescriptive guidance. We will use a redacted and anonymized qPCR case study to answer some of the questions that frequently come up.
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Ariadne Solutions
Application Note on Comparing Cut Points Acquired Using Stata and R Statistical Software
/ Blog / 0 commentsRead moreTo ensure highest levels of safety and efficacy for drug discovery and development, use of validated software, such as Stata, is highly recommended. However, open-source systems, such as R, can be used with due diligence. We used cut points obtained from Stata for 5 data sets and compared them to cut points obtained from R, and concluded that the results were statistically equivalent.
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Ariadne Solutions
White Paper on Cut Point Determination for ADA Data and Auditing of Pharmacokinetic Large Molecule Method Validation
/ Blog / 0 commentsRead moreArtificial intelligence empowered Red Thread® helped KCAS Bioanalytical and Biomarker Services achieve higher throughput, consistent outcomes, objective analysis, and net return on investment of 20.5 and 13.6 for cut point determination of ADA data and auditing of large molecule method validation data for pharmacokinetic studies respectively.
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Ariadne Solutions
Case Study on Auditing of Pharmacokinetic Small Molecule Method Validation
/ Blog / 0 commentsRead moreAutomating the review and auditing of small molecule method validation data for pharmacokinetic studies allowed for Arrowhead Pharmaceuticals to achieve higher efficiencies through faster reviews and reduced errors leading to potential rework along with increased transparency with the CRO partner.
