Hurdles to overcome from preclinical development into GMP manufacturing
02 Dec 2025
Oligonucleotide CMC & Process Development
- Defining acceptance criteria
- Over-designed oligonucleotide drugs - hurdles in upscaling and GMP analytics
- Expectations in scalability, quality, budget and time lines - finding an adequate CDMO
- Impact of formulation and route of administration on GMP manufacturing and budget
- Open discussion about experiences in GMP projects
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