November / December 2017 Issue Cover

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Engineers looking to enter the biomanufacturing workforce may feel unprepared without a background in cell culture or chromatography.

Crossing Over to Large Molecules: Bridges to Biomanufacturing

Cover: We interviewed four biomanufacturing professionals who made the switch from traditional pharmaceutical processes to biomanufacturing to identify the bridges that helped them make the transition.

Gen X, Millennial: The Mentoring Relationship, Step by Step

Feature: Young engineers need mentoring to succeed.  Our case study of a mentoring relationship between Gen Xer Kerren Bergman and Millennial Kelly Scalva discusses lessons learned and the joint successes in their personal and professional lives.

Data Integrity: Compliance, Transparency, Control

Special Report: Today, the need for data integrity is foremost in our documentation, analytical records, measurements, and requirements. This Special Report provides insights into how we manage, use, and incorporate data to protect the integrity of all values, measurements, and processes.

In This Issue

Article
Technical
Statistical Approach for CU Testing CPV Batches & Comparison with USP <905> UDU

The USP <905> UDU test, widely used for batch release since 2007, is no longer supported by FDA. We propose a two-sided tolerance interval method to alleviate this deficiency. The approach provides 50% confidence and 95% probability that future samples from the batch will conform to USP <905> criteria. In addition, this new statistical assessment provides the same practical...

Crossing Over to Large Molecules
Features
Crossing Over to Large Molecules

Improvements in genetic engineering techniques have fueled the growth of well-characterized large molecules since the 1980s. Today, revenues from the sale of biopharmaceuticals in the United States exceed $100 billion annually. 1

  • 1Ernst & Young Global Limited (EY). "Key Dealmaking Insights," in Biotechnology Report 2016: Beyond Borders.
ISPE Pharmaceutical Engineering
Special Reports
Lessons Learned from the Sarbanes-Oxley Act

Fifteen years ago, corporations embarked on a journey toward SOX compliance; along the way they have learned a tremendous amount about data integrity as it relates to financial systems. Those lessons learned are directly applicable to many of the data-integrity challenges facing the pharmaceutical industry today.