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Economic and Cost Factors of Bioprocess Engineering
Published in Kenneth E. Avis, Vincent L. Wu, Biotechnology and Biopharmaceutical Manufacturing, Processing, and Preservation, 2020
Because fill and finish plants are expensive to operate, few biotechnology companies have built them and, instead, rely on outside contractors for this operation. A fill and finish plant requires a large capital expenditure that realizes its best rate of return when it is always occupied. Since few biotech companies have enough products to keep a facility full, it is less expensive to contract this work out to a specialist. The cost of the fill and finish work, including packaging, may represent a substantial part of the total cost of goods. For example, fill and finish (with packaging) of a parenteral drug (say, under 10 mL/vial) in an efficiently operating plant may cost $2 to $3 per vial for a liquid fill and twice that for a lyophilized product.
Optimal production decisions in biopharmaceutical fill-and-finish operations
Published in IISE Transactions, 2020
Tugce Martagan, Alp Akcay, Maarten Koek, Ivo Adan
Fill-and-finish operations include activities related to formulation, freeze-drying, filling, and sealing an active ingredient into its final form. State-of-the-art technologies can deliver consistent production yields in finish-operations. However, fill-operations remain a critical challenge in practice, as it relies on complex and unpredictable biological processes, such as freeze-drying. This leads to yield uncertainty in fill-operations. In addition, fill-and-finish operations are labor- and cost-intensive, and require specialized handling with strict limitations on batch sizes and capacity. As a response to these challenges, most biopharmaceutical companies tend to freeze their production decisions for a predefined period of time. This allows companies to improve their visibility and stability in manufacturing processes. However, using such freeze periods adds another level of challenge, as it reduces planning flexibility.