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Impurities Testing Using qPCR & Digital PCR

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Purification

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.

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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.

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Comparability

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.

 
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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

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Vericheck ddPCR Mycoplasma Detection Kit

Confidently test for Mycoplasma contamination with high specificity, reproducibility, and precise measurement of up to 112 Mycoplasma species using Droplet Digital™ PCR.

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.