Stephanie Johnson, Pfizer, explains how off-platform triggers, single-owner risk registers, and traceable prior knowledge keep protein formulation programs on track.
News|Articles|August 1, 2019
Bringing Gene Therapies to Market
Biopharma industry faces production challenges as gene therapies move from clinical to commercialization.
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The approval of the first gene therapies and technology advances have spurred research and investment for new treatments and provided hope for patients. Researchers are now talking about “cures” versus “treatments,” says Eric Langer, managing partner, BioPlan Associates, in an interview with BioPharm International. Turning clinical processes into an operational process will prove challenging.
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The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.
Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.
Pauric Bannigan, Intrepid Labs, explains how physics-informed machine learning aids formulation and why regulators still want experimental data.
Pauric Bannigan, Intrepid Labs, explains where AI speeds formulation decisions, why data is the bottleneck, and how active learning trains models with far less data.
Stephanie Johnson, Pfizer, discusses how platform formulations moved 2 Pfizer protein programs to IND in 8 months by redistributing, not removing risk.
Shubhajit Paul, a senior research fellow in Boehringer Ingelheim’s Department of Material Analytical Sciences, spoke with PharmTech at AAPS PharmSci 360 to explain how tabletability prediction can be improved for roller-compacted formulations.
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