Diagnose deviations, design the next run.
Turn process data into decisions. Rosalind diagnoses upstream and downstream deviations, designs characterization studies, and plans scale-up with the reasoning written down.
Built for: Process development, MSAT, Manufacturing science
Challenges
- Root causes take too long to find: A titer drop or recovery loss triggers days of meetings before anyone agrees on what to test next.
- DOE design is a specialist skill: Choosing factors, ranges, and designs for process characterization is bottlenecked on a handful of statisticians.
- Scale-up knowledge is tribal: What worked at 2 L rarely transfers cleanly to 2,000 L, and the reasons live in people's heads.
What LiteFold does
- Cell culture process optimization: Diagnose deviations in titer, viability, and product quality and propose the experiments that close the gap fastest.
- Process characterization study design: Generate statistically sound DOE plans and identify critical process parameters with a clear rationale.
- Downstream recovery investigations: Work through Protein A and polishing step losses with structured hypotheses ranked by likelihood and cost to test.
- Scale-up and tech-transfer strategy: Build a scale-up plan that carries CPPs, control strategy, and risk assessments from bench to GMP.