Bioprocessing Analytics webinars
Take advantage of knowledge-sharing sessions with industry experts
Categories
MycoSEQ system
resDNASEQ system
MicroSEQ system
Gene therapy
resDNASEQ system
Leading the way in rapid quantitation of host cell DNA
The removal of host cell impurities is a critical step in the purification of biopharmaceutical products. A major challenge
is the accurate and sensitive quantitation of host cell DNA impurities.
To ensure product quality, the amount of residual DNA in a drug’s final dosage form must meet regulatory guidelines established by the World Health Organization (WHO), the European Pharmacopoeia, the US Food and Drug Administration (FDA), and other regulatory agencies.
A host cell quantitation system should be designed with the sensitivity to meet or exceed regulatory requirements, while enabling high throughput and cost-effectiveness to enable robust process clearance study design.
Applied Biosystems™ resDNASEQ™ host cell residual DNA quantitation systems measure levels of residual DNA from common host cell lines used in the production of biopharmaceutical products.
Development and validation of quantitative real-time PCR for the detection of residual HEK293 host cell DNA
Learn more
Validation guidance for residual host cell DNA testing of biologics
Learn more
Accelerating vaccine development by innovative purification solutions and state-of-the-art quality testing
Learn more
MycoSEQ system
Industry- and regulatory-accepted rapid mycoplasma detection system
Mycoplasmas, the smallest known free-living organisms, are relatively common bacterial contaminants of mammalian cell cultures. Regulatory guidance requires that all products derived from mammalian cell culture be tested for the presence of mycoplasmas.
Mycoplasma detection is difficult—sometimes impossible—when using traditional microbiological techniques. The compendial mycoplasma test uses a cell culture method and takes 28 days to get results. However, in 2007, the European Pharmacopoeia accepted nucleic acid tests, such as real-time PCR, as an alternative method for traditional mycoplasma detection after validation.
The Applied Biosystems™ MycoSEQ™ Mycoplasma Detection System integrates real-time PCR assays, instruments, and software with optimized Applied Biosystems™ PrepSEQ™ sample preparation reagents, delivering results in hours, not days. This enables you to test at multiple points in cell lines, cell banks, and harvest media, increasing your productivity and reducing risk of downstream contamination.
Global regulators’ FAQs on CMC in IND/BLA filing:
Learn more
A retrospective look at past mycoplasma validation queries and responses
Making the switch:
Learn more
The evaluation, implementation, and validation of bringing rapid mycoplasma testing in-house to expedite lot release of recombinant protein product
Accelerating vaccine development by innovative purification solutions and state-of-the-art quality testing
Learn more
Mycoplasma matters:
Learn more
Answers to your real-world mycoplasma testing questions
Gene therapy
Meet regulatory standards with confidence
Tackling the critical issues pertaining to raw and starting materials for cell and gene therapy manufacturing
Learn more
Business of regenerative medicine III: An expert panel discussion
Learn more
Regulatory FAQs and common concerns for cell and gene therapy raw and starting materials
Learn more
Our gene therapy products undergo clear quality control tests that must be performed throughout the manufacturing process for lot release and regulatory filing to ensure product safety. These solutions save time and are accepted by regulators for lot release testing. We offer rapid molecular methods for contaminant and impurity testing, such as mycoplasma screening during cell culture and residual DNA testing following virus harvest and purification.
MicroSEQ system
The complete solution for reliable genotypic microbial identification
Used in top pharmaceutical companies worldwide, the Applied Biosystems™ MicroSEQ™ Rapid Microbial Identification System is ideal for environmental monitoring, contamination investigation, root cause analysis, raw materials testing, and microbial identification in small molecule and biopharmaceutical manufacturing and service laboratories.
The MicroSEQ system combines the benefits of PCR and DNA sequencing technologies to enable highly accurate results.
The key to accurate microbial identification is a powerful database. The MicroSEQ system includes extensive microbial, bacterial, and fungal libraries, built on meticulously curated collections and validated using multiple techniques to enable accurate identification. We don’t just collect data from other sources—we validate our own findings and confirm the accuracy of all entries. Trust the largest validated and curated in silico database, which includes over 10,000 strain types that have been validated by our scientists and collaborators.
Microbial identification via DNA-sequencing methods to support risk mitigation strategies
Learn more
Validation guidance for residual host cell DNA testing of biologics
Learn more
Development and validation of quantitative real-time PCR for the detection of residual HEK293 host cell DNA
Learn more
Connect with a bioprocessing representative
For Research Use Only. Not for use in diagnostic procedures. © 2020 Thermo Fisher Scientific Inc. All rights reserved.
All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. COL24359 0920
thermofisher.com/biopro-info-seq-analytics
Contact us