White Paper: Validation of a Duplex qPCR Assay to Detect Residual Sf9 Host Cell DNA and Baculovirus DNA

Current regulatory authorities (WHO, EMA and US FDA) limited the accepted amounts of residual DNA in biological products making it extremely important to have a sensitive method of quantifying residual host cell DNA. Among the methods of detecting residual DNA, qPCR is the most widely used for residual DNA quantitation due to its sensitivity, accuracy, precision, and time-saving capability.

In this white paper, we share the development and validation of a new, highly sensitive and accurate integrated solution for detection and quantitation of low level Sf9 and Baculovirus DNA to help meet regulatory requirements.

You will learn:

  • Summary of current regulatory requirements for residual host DNA clearance for biological products and what that means for gene therapy applications
  • Demonstration of a streamlined, automated workflow for quick quantification of residual Sf9 host cell DNA and helper baculovirus DNA
  • Performance specifications for the new Applied Biosystems resDNASEQ Quantitative Sf9 and Baculovirus DNA system


Who should read this white paper:

  • Process Development Scientist
  • Analytical Development Scientist
  • Quality Control, Quality Assurance Scientist
  • Regulatory/CMC Managers

 

Download the Document

    Please fill out the information below to request information on the products you selected. If you are already registered, or have requested a quote before, and this information will be filled out for you.

  • Please enter your first and last name.

  • Please enter the name of the company or institution you work at.

  • Please enter your mailing address.

  • Please enter the e-mail address you would like to be contacted at.

  • Please enter the phone number you would like to be contacted at.

  • The resDNASEQ Quantitative Sf9 and Baculovirus DNA Kit is the first commercially available qPCR duplex assay for the detection of Sf9 host-cell DNA and Baculovirus DNA. Would you like a Thermo Fisher technical professional to contact you (by email or telephone) to learn more about resDNASEQ Quantitative Sf9 and Baculovirus DNA Kit or any other resDNASEQ residual DNA kit?


  • By submitting my personal data, to CompareNetworks, I acknowledge it will be shared with the Thermo Fisher Scientific group for processing in accordance with the Thermo Fisher Scientific Privacy Policy.

    Yes, I agree for the Thermo Fisher Scientific group to contact me by e-mail and telephone to inform me of events, products, services and promotions offered in connection which they believe may be of interest to me. I can withdraw my consent and unsubscribe at any time by e-mailing [email protected].

  • By submitting this form, you consent to American Pharmaceutical Review storing your email address and contact information, transmitting your contact information to selected trusted partners, and customizing your experience based on the data you enter. You can also stay up-to-date on the latest news, new technologies, and more delivered to your email inbox by selecting your subscription preferences on the next page.