Knowledge Briefs

In effort to address the industry’s need for current, relevant, and useful content, ISPE has developed concise, problem-solving documents called Knowledge Briefs. These tools are easy-to-read resources that help industry professionals get up-to-speed quickly on contemporary pharmaceutical industry topics.

Knowledge Briefs are intended to provide an overview of a discipline-specific subject. Knowledge Briefs are presented in several levels ranging from Basic to Advanced. The context and relevance of the subject can be easily understood and implemented into day-to-day job functions. Each brief includes links to additional ISPE resources such as technical documents, Pharmaceutical Engineering articles, Communities of Practice, and educational seminars to provide more specific and detailed information on the subject.

Knowledge Briefs are available for immediate download.

Price: free to ISPE Members, $5 US / €3 to nonmembers.

Biotechnology Basics
Adapted from the ISPE Training Course on Biotech Basics
Level: Basic

This Knowledge Brief provides basic concepts explaining the science of biotechnology and how science and process are combined to lead to the manufacture of a human therapeutic product.

 Members: Download now
 Nonmembers: purchase from the ISPE Online Store

Commissioning and Qualification of Biopharmaceutical Facilities
The information contained in this Knowledge Brief was extracted from the ISPE Baseline Guide®: Biopharmaceutical Facilities, authored by the Biopharmaceutical Manufacturing Facilities Baseline Guide® Task Team
Level: Intermediate

This Knowledge Brief summarizes the considerations involved in the commissioning and qualification of a biopharmaceutical manufacturing facility.

 Members: Download now
 Nonmembers: purchase from the ISPE Online Store

Quality by Design
by John Berridge, PhD
Level: Intermediate

This Knowledge Brief provides and explains the basic elements of Quality by Design (QbD).

 Members: Download now
 Nonmembers: purchase from the ISPE Online Store