16 GCC Closed Forum: ICH M10 implementation; NGS, qPCR/dPCR, flow cytometry validation; tissue biomarkers; IS response; immunogenicity harmonization; bioanalytical industry status.

The 16th GCC Closed Forum was held in Orlando, FL, USA, on 23 June 2023. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at the meeting included: IS response, flow cytometry, changes to the bioanalytical industry, NGS assays, biomarker assay for tissues, dPCR validation, immunogenicity harmonization and ICH M10 implementation.

Superovulatory response, anti-Müllerian hormone concentration and antral follicle count in Holstein cattle with short or long anogenital distance.

To understand the mechanisms underlying the inverse relationship between anogenital distance (AGD) and fertility in dairy cattle, we determined if embryo yield and quality differed between cattle of short- and long-AGD (Study 1), and whether anti-Müllerian hormone (AMH), antral follicle count (AFC) and superovulation responses differed by AGD group (Study 2). In Study 1, records of embryo yield and quality in Holstein heifers (n = 43) and cows (n = 14) from two commercial dairy herds were analyzed, retrospectively. Short- and long-AGD groups were based on the median AGD cut-points of 113 and 134 mm, for heifers and cows, respectively.