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.
|Articles|May 15, 2014
- Pharmaceutical Technology-05-15-2014
- Volume 2014 eBook
- Issue 2
Achieving and Maintaining Compliance Using Continuous Monitoring Systems
Author(s)Asbjørn Jensen
Challenges encountered when implementing a continuous monitoring system are reviewed.
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There are a number of challenges when implementing a continuous monitoring system.
The author presents issues encountered at Novo Nordisk and discusses how expanding the scope of monitoring, together with frequent and thorough review of data, can help keep a facility in compliance.
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Articles in this issue
over 12 years ago
Potential Benefits Drive Interest in Continuous Manufacturingover 12 years ago
Continuous Bioprocessing Challengesover 12 years ago
Optimizing the Sterilization of Liquids in Sealed Containersover 12 years ago
Using Modular Systems in Biopharmaceutical Manufacturingover 12 years ago
Determining Protein Oxidation Induced During Fill-Finish Operationsover 12 years ago
Single-Use Technology in Parenteral Fill/FinishAdvertisement
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Subathra Ramamoorthy, Veranova, on when to escalate to structural elucidation and pair orthogonal techniques when characterizing an impurity.
The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF, talks about spray drying for drying amorphous solid dispersions and Raman spectroscopy’s role as a quantitative analytical tool.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF in Tarrytown, spoke with PharmTech at AAPS PharmSci 360 about formulation and characterization challenges for amorphous solid dispersions.
FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.
Vibha Jawa, PhD, chief scientific officer at EpiVax, explains why the need for animal studies varies by modality and what it takes for organ-on-chip and other human-relevant models to replace these studies in IND-enabling toxicology work.
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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