The quarterly scientific journal

24/03/2022

Optimization and Validation of digital PCR assays

  • analytical development
  • assays
  • digital PCR
  • dPCR
  • PCR
  • QC
  • quality control

Following the implementation and qualification of a digital PCR platform, Clean Cells has completed optimization and validation work according to ICHQ2(R1) and 21CFR part 11 to support internal methods and culminating in full GMP compliance.

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07/02/2022

Drug development post-pandemic:

  • analytical development
  • drug development
  • post pandemic
  • process development

COVID-Adjacent drug development, post-pandemic gets a boost in areas such as ACE2 receptor and cancer therapeutics. Biodextris and the Clean Biologics group assist sponsors from process and analytical development to GMP manufacturing.

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16/09/2021

Implementing digital PCR : a quality leap for the quantification of nucleic acids

  • analytical development
  • digital PCR
  • dPCR
  • PCR
  • QC
  • quality control

Our analytical development team has implemented an innovative digital PCR (dPCR) equipment for the development and validation of QC methods used on biopharmaceutical products in GMP and non-GMP setups.

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