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AI in Cell Line Development: What Machine Learning Can and Cannot Do Yet

AI in Cell Line Development: What Machine Learning Can and Cannot Do Yet AI is dominating biotech headlines, and regulators are paying attention. In January 2025, FDA released its first draft guidance on AI for drug and biologic regulatory decisions. Meanwhile, researchers are testing AI in cell line development to identify strong clones sooner. The … Continue reading AI in Cell Line Development: What Machine Learning Can and Cannot Do Yet

Cell Line Technology Transfer: What Actually Travels With the Vial

Cell Line Technology Transfer: What Actually Travels With the Vial Trade policy just pushed cell line technology transfer up the priority list. On September 23, 2026, Commerce’s Bureau of Industry and Security published procedures implementing Proclamation 11020. Those procedures took effect on September 29, 2026. The notice sets a zero tariff rate for qualifying specialty … Continue reading Cell Line Technology Transfer: What Actually Travels With the Vial

Protein Purification Services: What Buyers Should Look For in a Downstream Processing Partner

Protein Purification Services: What Buyers Should Look For in a Downstream Processing Partner Protein purification services are the bridge between a productive cell culture and a usable protein product. Upstream production creates the material, but downstream processing determines whether that material meets the purity, activity, and quality specifications your program actually needs. Choosing a partner … Continue reading Protein Purification Services: What Buyers Should Look For in a Downstream Processing Partner

Biosimilar Cell Line Development After FDA’s Push to Streamline Approvals

Biosimilar Cell Line Development After FDA’s Push to Streamline Approvals Biosimilar cell line development just gained new strategic weight. In October 2025, FDA issued draft guidance on comparative efficacy studies. It proposed that these studies no longer be the default for most therapeutic protein biosimilars. Instead, the agency would rely more on comparative analytical data, … Continue reading Biosimilar Cell Line Development After FDA’s Push to Streamline Approvals

Potency Assay Development Starts With the Cell Line

Potency Assay Development Starts With the Cell Line FDA reopened the potency conversation this summer. Consequently, potency assay development is back on many CMC timelines. On August 20, 2026, the agency published a draft guidance, Potency Assessment of Active Immunotherapy Products, under docket FDA-2026-D-8561. Comments close November 18, 2026. The draft addresses active immunotherapy products, … Continue reading Potency Assay Development Starts With the Cell Line