Analytical Method Development

Feb 02, 2018
Pharmaceutical Technology
The following study describes a methodology to establish, control, and characterize an aerosolized bioburden within a test chamber and determine the settling rate of the bioburden.
Jan 16, 2018
Pharmaceutical Technology's In the Lab eNewsletter
By Pharmaceutical Technology Editors
Automated Control Concepts has launched Lab Owl bioreactor control system for labs using cell culture and fermentation applications.
Dec 05, 2017
By Pharmaceutical Technology Editors
Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.
Sep 02, 2017
Pharmaceutical Technology
Forced degradation studies can identify stability problems for drug substance and drug products.
Aug 02, 2017
Pharmaceutical Technology
Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.
May 30, 2017
The pharmaceutical industry is making efforts by internally assessing, developing, and implementing semi-continuous manufacturing processes to improve manufacturing efficiencies.
Apr 02, 2017
Pharmaceutical Technology
The primary impact of using the covalidation model is the expedited analytical method qualification of both the transferring and receiving laboratories.
Feb 02, 2017
Pharmaceutical Technology
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
Feb 02, 2017
Pharmaceutical Technology
Although limitations must be overcome, mass spectrometry is having a great impact on biologic development and manufacturing.
Jan 19, 2017
Researchers were not able to replicate all of the findings in five highly-cited cancer biology papers.
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