Quantitative Standards for Monitoring Biocontaminants by NGS
Advances in biopharmaceutical manufacturing require faster and more sensitive biocontaminant testing to achieve safe biomedicines. Traditional animal and cell-based methods can take up to a month or more, lack sensitivity and create delays in production.
The Accukit™ Adventitious Agents (AA20) assay and standard system is an NGS-library prep workflow for 20 common adventitious agents found in Chinese hamster ovary cell bioproduction processes. The Accukit contains all the necessary reagents for library preparation of cell lysate samples to target a panel of adventitious agents (Table 1) to achieve a sensitivity of 10 copies of target per ml of lysate.
Table 1: Adventitious Agents Targets in Accukit AA20
|Epizootic Haemorrhagic Disease virus
|Human Adenovirus 2
|Minute virus of Mice
|Porcine Circovirus 2
|Bovine Parainfluenzavirus 3
|Porcine Circovirus 1
|Bovine polyoma virus
|Porcine Hemagglutinating Encephalomyelitis virus
|Bovine respiratory syncytial virus
|Porcine transmissible gastroenteritis virus
|Bovine viral diarrhoea virus
|Seneca Valley Virus (Senecavirus)
|Cache Valley virus
Why it works:
The Accukit relies on matched DNA and RNA SNAQ™-SEQ spike-in standards that are added to the samples prior to extraction as a quantitative process control to ensure assay performance. By adding the standards to the sample they can provide a quantitative measure of the sensitivity and limit of detection achieved by the assay for EACH sample. This is critically important to providing confidence in the negative result.