Over the past several years, the CELDi Biopharmaceutical Operations Initiative at UC
Berkeley has worked with a variety of biopharmaceutical firms to optimize production
planning and supply chain management. Production and supply chain operations in the
biopharmaceutical industry feature a variety of characteristics that make production
and inventory planning challenging. For instance,
• Bulk production has significant economies of scale, and capacity is shared, leading
to campaign-style production.
• Bulk production is either in batches, with significant levels of random yield, or
semi-continuous (known as a perfusion process), with random production rates
(although rates are known soon after production starts).
• There is significant region-specific differentiation between bulk production and
finished goods production (filling/finishing/labeling).
• There is an expiration period for bulk drugs, and a new, non-cumulative expiration
period for finished drugs.
• In some cases, bulk production batches must be entirely differentiated (that is,
processed into finished goods for specific markets), even if it would be more
efficient to partially differentiate them.
• Quality analysis can take significantly more time than production, with a very
high variability in the required amount of time.
• In many cases, some but not all production steps are outsourced, so:
– Utilization of this outsourced capacity must be “scheduled” in advance.
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