Cost Considerations Drive Lean Technology in Biomanufacturing
Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.
The approval of biosimilars for the US market has created a need for more efficient manufacturing processes.
Manufacturers are developing processes for cost efficiency and reliability using newer technology to compete with innovator products manufactured with legacy processes.
Innovations include more productive cell lines, single-use systems, and powerful analytical methods.
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Pharmaceutical Technology’s 2017 Biologics and Sterile Drug Manufacturing eBook.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
