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Article ong>Fundamentalsong> ong>ofong> ong>Viralong> ong>Clearanceong> ong>Studiesong> ong>withong> a ong>Focusong> on Chromatography
Effective ong>viralong> ong>clearanceong> ong>studiesong> remain one ong>ofong> the challenges facing manufacturers ong>ofong> biologics. These ong>studiesong> are an essential part ong>ofong> process validation and are critical to ensure drug safety. This…

Article Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech. By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…

Article Report from the 6th International HTPD Conference
The biggest challenge is still the people and Quantitative Structure-Activity Relationship (QSAR) plus mechanistic modeling were two key take-home messages from the 6th International conference devote…