Please join us for an Open Scientific Discussion (OSD) hosted by the AAPS Biomarkers and Precision Medicine (BPM), Bioanalytical (BA), and Gene and Cell Therapy Products (GCTPs) Communities on the following topic:

Current Practices for qPCR/dPCR in Regulated Bioanalysis (Part 1)

·         What are the MIQE and ISO 20395:2019 guidelines and how do they inform PCR assay development and validation to ensure assay performance and quality?

·         What other initiatives are in progress to address best practices for PCR testing in a regulated environment?  

·         What are the similarities and differences in recommendations amongst these guidelines for using qPCR/dPCR in regulated bioanalysis?

Discussion Leaders:

Mikael Kubista (TATAA Biocenter), Jim Huggett (National Measurement Institute, LGC), and Amanda Hays (BioAgilytix)  

Organized by:  

Lakshmi Amaravadi (Dewpoint Therapeutics), Carmen Fernández-Metzler (PharmaCadence), Karen Quadrini (Passage Bio), and Yan Ni (Passage Bio)

We start at 12:00 EST sharp. To avoid interruptions, please dial in before noon and mute yourself until Q&A starts.

(Please remain on mute unless asking questions)

When: Tuesday, March 28, 2023, 12 pm – 1 pm EST

Where: Please join from your computer, tablet or smartphone.
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Background material:

MIQE Guidelines: Minimum Information for Publication of Quantitative Real-Time PCR Experiments | Clinical Chemistry | Oxford Academic (oup.com)

The Digital MIQE Guidelines Update: Minimum Information for Publication of Quantitative Digital PCR Experiments for 2020 - PubMed (nih.gov)

ISO - ISO 20395:2019 - Biotechnology — Requirements for evaluating the performance of quantification methods for nucleic acid target sequences — qPCR and dPCR

Best Practices in qPCR and dPCR Validation in Regulated Bioanalytical Laboratories - AAPS Journal 2022

Please feel free to share with colleagues who may be interested in this topic.

Thank you,

The Leadership Teams of the AAPS BPM, BA, and GCTPs Communities