12th GCC Closed Forum: Critical Reagents; Oligonucleotides; CoA; Method Transfer; HRMS; Flow Cytometry; Regulatory Findings; Stability and Immunogenicity

Figures & data

Table 1. Platforms and criteria used to assay oligonucleotides.

Platform	Criteria	Percent of respondents, more than one option possible (%)
HPLC	≤15 (≤20% LOQ) ≤20 (≤25% LOQ) ≤30 (≤35% LOQ)	100 14 14
LCMS	≤15 (≤20% LOQ) ≤20 (≤25% LOQ) ≤30 (≤35% LOQ)	78 28 6
Hybridization ELISA	≤15 (≤20% LOQ) ≤20 (≤25% LOQ) ≤30 (≤35% LOQ)	13 87 33
Branched DNA	≤30 (≤35% LOQ) Other	100 50
PCR	≤15 (≤20% LOQ) ≤20 (≤25% LOQ) ≤30 (≤35% LOQ) Other	50 17 33 50

ELISA: Enzyme-linked immunosorbent assay; HPLC: High-performance liquid chromatography; LOQ: Lower limit of quantitation; PCR: Polymerase chain reaction.

Table 2. Potential content for a macromolecule certificate of analysis.

Requested (%)	Elements
>95	Batch/lot number Storage conditions
>80	All of the above plus Retest date Expiration date Purity (280 nm) Potency (activity test) Source Composition
>70	All of the above plus Known hazards, care and handling instructions
>60	All of the above plus Reconstitution stability
>50	All of the above plus Label ratios on tagged reagents