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.
News|Articles|May 15, 2015
- Pharmaceutical Technology-05-15-2015
- Volume 2015 eBook
- Issue 2
Controlled Nucleation for a Monoclonal Antibody Formulation—A Case Study
Author(s)Joseph Brower, Eugene Wexler, PhD
This study evaluates the impact of controlled nucleation on the ability to optimize a lyophilization cycle for a monoclonal antibody formulation.
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This study evaluates the impact of controlled nucleation on the ability to optimize a lyophilization cycle for a monoclonal antibody formulation.
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Articles in this issue
over 11 years ago
Validating and Implementing a Rapid Sterility Testing Methodover 11 years ago
Cleanroom and Facility Planning: Getting Beyond Cost Per Square Footover 11 years ago
Aging Facilities: Aseptic Manufacturing Faces the FutureAdvertisement
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The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
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.
Bill Williams, AAPS, compares KinetiSol and spray drying for amorphous solid dispersions, covering 75% drug loading, pill burden, weakly basic drug release, and process limits.
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, explains how off-platform triggers, single-owner risk registers, and traceable prior knowledge keep protein formulation programs on track.
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