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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…
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…
A unique team of specialists in data generation and artificial intelligence are co-developing an AI genomic model capable of predicting genomic edits that improve commercial-scale protein production. This collaboration between Triplebar and UC Berkeley—with funding from the U.S. Department of Defen…
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