Building a More Robust Biomanufacturing Network
Biogen faced a critical operational bottleneck when the addition of a new production bioreactor significantly increased buffer preparation demands beyond internal capacity. To address labor constraints, facility limitations, and the need to maintain production schedules, Biogen partnered with Thermo Fisher Scientific and other suppliers to outsource buffer manufacturing. The transition reduced internal buffer preparations from 23 per batch to just 1.25 outsourced preparations per batch, and eliminated 250 full-time employee (FTE) hours per batch previously dedicated to buffer preparation. Although material costs increased from $27,000 to $56,000 per batch, the savings in labor and the reallocation of FTEs to higher-value downstream tasks more than justified the investment.
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- Internal buffer preparations per batch dropped from 23 to zero, with outsourced preparations averaging just 1.25 per batch.
- 250 FTE hours per batch dedicated to buffer preparation were completely eliminated, with staff redirected to higher-value downstream operations.
- No FTE positions were eliminated; instead, employees gained cross-training opportunities in additional downstream processes.
- Material costs increased from $27,000 to $56,000 per batch, but were outweighed by labor savings and productivity gains.
- Solution stability testing confirmed a minimum 6-month expiry, with many solutions such as acetic acid and sodium hydroxide assigned a 24-month shelf life.