Impurities Testing Using qPCR & Digital PCR
Identify the best purification strategy and migrate it from lab to process scale with a reliable stream of workflow components from instruments to resins and columns.
Quantification of Impurities
Employ a robust purification strategy to reduce contaminants such as host cell proteins (HCPs) and host cell DNA (hcDNA) to safe levels.
Produce precise, accurate, and reproducible data to demonstrate comparability to the originator biologic and satisfy regulatory requirements.
Mycoplasma Contamination in Cell Culture
Choosing a Mycoplasma Detection Strategy
Get ahead of the common and costly problem of mycoplasma contamination of cell culture to avoid losing time, money, and product.
Direct Cell Culture
Unfortunately, direct cell culture generally takes 28 days which makes it impractical for most labs.
Droplet Digital™ PCR Based Mycoplasma Testing Solution
Multiplex Probe-Based Test
Designed and validated to meet requirements from European Pharmacopoeia (EP), U.S. Pharmacopoeia (USP) and Japanese Pharmacopoeia (JP).
High Specificity and Sensitivity
Providing low false-positive results due to low cross reactivity with related species. Validated Limit of Detection (LoD) studies determine the lowest detectable concentration of Mycoplasma.
Software to Help Assist with Regulatory Compliance
Auto gate your results based on a positive control, removing manual intervention and data interpretation, and streamlining data analysis.