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The FDA recently announced the participants in its PreCheck pilot program, an initiative designed to encourage earlier collaboration between regulators and companies developing new domestic pharmaceutical manufacturing facilities. By shifting facility readiness discussions earlier in the developmen…
Biopharmaceutical manufacturing processes are becoming more complex, prompting manufacturers to evaluate filtration based on its impact across the entire process rather than as a standalone unit operation. Filtration decisions can influence everything from system footprint and flow performance to i…
Single-use technologies have reshaped biopharma manufacturing facility design, capacity strategy, and flexibility over the past decade. The industry has expanded with a growing range of targeted therapies and emerging modalities, which has led to manufacturers adopting single-use systems to meet de…
The demands on pharmaceutical manufacturing quality teams are growing as they manage larger volumes of data driven by increasingly complex therapies and evolving regulatory expectations. In response, artificial intelligence is emerging as a powerful tool to help quality professionals synthesize inf…
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