8 Biomanufacturers
2 Supply Partners
1 Innovation Hub

  • AV,
    mycoplasma,
    sterility
  • Technology &
    Regulatory
    Landscaping
  • Benchmarking
    Survey & FDA
    meeting
  • White paper
  • Assay
    validation
DeliverableAvailable Company BenefitWhen
White paper containing URS for development of new rapid methods and plans to overcome barriers of adoption. This technology will have a huge impact on drug substance inventories and working capitalWhite paper will summarize current vs future/ proposed practice for Rapid Sterility & AV testing, with gaps that need to be addressed to reach ultimate goal of ILM/RTR. Identify what needs to happen to drive regulatory acceptance. Inclusion of URS.

ILM/RTR 10 year goals:



Speed

↓ Cost

↑ Quality




  • Speed up product release time for Sterility from 14 days to < 2 days

  • Speed up product release time for Adventitious Agent from 35 days to < 2 days

  • 90% reduction in inventory quantity

  • Reduction in cost of non-quality to 2% of total operational costs



Q1 2019

Outputs from industry survey

Key Learning Points

Main point of dissatisfaction with current methods was time to result
Compendia methods are being used for lot release & new technologies are being used as secondary means
Mycoplasma testing showing trend to move toward molecular alternative
100% believe that RMM will be in place as a release test in 5-10 years

Top 3 concerns for adopting new RMMs

  1. Regulatory acceptance
  2. Filing regulatory change control
  3. Time to validation

Top 3 activities to drive RMMs adoption

  1. Comparability studies between methods
  2. Collaboration with agencies
  3. Best practice/ standard protocol

If you could design the ULTIMATE test, rank the following features from most important to least important

Slide last updated : 11th December 2018