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.
|Articles|February 1, 2003
Pharmaceutical Technology Europe
- Pharmaceutical Technology Europe-02-01-2003
- Volume 15
- Issue 2
Liposomes, Part II: Drug delivery systems
Non-toxic and biodegradeable, biologically active liposomes encapsulate therapeutics to provide an attractive drug delivery system for the future.
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Liposomal formulations are increasingly being used in biopharmaceutical development projects. Good manufacturing processes must reproducibly fabricate lipid vesicles that are as uniform in size as possible, carry the drug in sufficient concentrations and remain stable for an acceptable shelf-life at varying temperatures. This article highlights some relevant production issues, such as drug incorporation, characterization and stability.
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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.
Subathra Ramamoorthy, Veranova, on when to escalate to structural elucidation and pair orthogonal techniques when characterizing an impurity.
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.
Aleksandra Zuraw, senior veterinary pathologist at Charles River, discusses how chain of custody, good laboratory practice, quality control, and validation are applied to digital pathology data used in drug development.
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FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.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, discusses the limitations of current preclinical testing approaches and how new approach methodologies can strengthen drug development.
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