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Resolution between full-length product and n-1 deletion decreasing at larger scale. Lab achieves baseline separation, 10L column shows significant overlap....

Post-thaw viability is 70-75%. Target is >85%. What parameters most impact recovery?...

How to handle ICH M7 when there are many alerting structures in the synthesis? Risk-based vs. comprehensive testing approach....

Seeing increased aggregation levels (HMW species) after the fill-finish step. Pre-fill is at 0.8% HMW, post-fill jumps to 2.1%. Specification is <2.5% but we need more margin....

How to set appropriate limits for cleaning validation? Current visual clean + swab approach may not be sufficient....

What level of glycan similarity is expected? How to handle batch-to-batch variability in the reference product?...

What is the current regulatory expectation for E&L studies? When should leachables study start relative to stability studies?...

What should the equipment qualification strategy look like for single-use systems? How much of the qualification burden falls on supplier vs end-user?...

What is the current industry expectation for media fill run frequency, duration, and acceptance criteria? Looking for guidance beyond the minimum regulatory requirements....

What are the key design considerations for a multi-product gene therapy facility? Especially interested in containment and changeover strategies....