Research & Development

Articles should illustrate sound research methods and results describing innovative methods and techniques in all aspects of the industry, including manufacturing and applied pharmaceutical science and technology, process and product understanding, and control.

Navigating the Life Cycle for Cell & Gene Therapies
Features
Navigating the Life Cycle for Cell & Gene Therapies
Cell and gene therapies are complex. As more therapies come to market in the hope of bringing advanced treatments and cures to rare, orphan, and difficult-to-treat diseases, designing quality standards for these personalized medicines is equally as complex.European Commission. EudraLex, Volume 4:...
Opportunities in Continuous Manufacturing of Large Molecules
Features
Opportunities in Continuous Manufacturing of Large Molecules
Continuous manufacturing has attracted significant interest over the past decade for small molecules formulated as drug products. The case for adopting continuous manufacturing platforms for manufacturing biologics (i.e., large proteins or biologic products such as vaccines) would, in principle, be...
Tracking the Journey of Barrier Technology
Features
2020 ISPE Barrier Survey: Tracking the Journey of Barrier Technology
For over two decades, the ISPE Barrier Isolator Survey has gathered meaningful data on the applications of barrier technology and been a resource for the fill-finish pharmaceutical industry community. This article provides context for the latest survey, the first in several years, and presents its...
Experimental Conditions Define the ATP Inference Space - ISPE Pharmaceutical Engineering
Technical
Experimental Conditions Define the ATP Inference Space
This article illustrates the importance of experimental conditions to evaluate analytical methods. Italicized text is used throughout the article to emphasize key points and illustrate formula variables.
Navigating the Life Cycle for Cell & Gene Therapies
Features
Navigating the Life Cycle for Cell & Gene Therapies
Cell and gene therapies are complex. As more therapies come to market in the hope of bringing advanced treatments and cures to rare, orphan, and difficult-to-treat diseases, designing quality standards for these personalized medicines is equally as complex.European Commission. EudraLex, Volume 4:...
Opportunities in Continuous Manufacturing of Large Molecules
Features
Opportunities in Continuous Manufacturing of Large Molecules
Continuous manufacturing has attracted significant interest over the past decade for small molecules formulated as drug products. The case for adopting continuous manufacturing platforms for manufacturing biologics (i.e., large proteins or biologic products such as vaccines) would, in principle, be...
Tracking the Journey of Barrier Technology
Features
2020 ISPE Barrier Survey: Tracking the Journey of Barrier Technology
For over two decades, the ISPE Barrier Isolator Survey has gathered meaningful data on the applications of barrier technology and been a resource for the fill-finish pharmaceutical industry community. This article provides context for the latest survey, the first in several years, and presents its...
Experimental Conditions Define the ATP Inference Space - ISPE Pharmaceutical Engineering
Technical
Experimental Conditions Define the ATP Inference Space
This article illustrates the importance of experimental conditions to evaluate analytical methods. Italicized text is used throughout the article to emphasize key points and illustrate formula variables.
Article
Technical
Defining the Analytical Target Profile
Analytical target profile criteria for judging the quality of results generated by analytical methods are framed in an optimization paradigm by illustrating the ATP criteria as a loss function. In the case where specifications are based on quality arguments and process capability, a...
Article
Technical
EU Clinical Trials Regulation: The Application Process
One of the major changes introduced by the European Union (EU) regulation 536/2014 is an application procedure that will require sponsors to apply for authorization to conduct an interventional/low-intervention clinical trial (CT) via a new EU portal.3...