November / December 2017

November / December 2017 Issue Cover

CoverCrossing Over to Large Molecules: Bridges to Biomanufacturing
Engineers looking to enter the biomanufacturing workforce may feel unprepared without a background in cell culture or chromatography. 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.

FeatureGen X, Millennial: The Mentoring Relationship, Step by Step
Young engineers need mentoring to succeed. How does this relationship play out? And how does one become a mentor or mentee? Our case study of a mentoring relationship between Gen Xer Kerren Bergman and Millennial Kelly Scalva discusses lessons learned and the joint successes both have seen in both their personal and professional lives.

Special ReportData Integrity: Compliance, Transparency, Control
Today, the need for data integrity is foremost in our documentation, analytical records, measurements, and requirements. Data integrity demonstrates that processes operate within proscribed limits, and ensures that we can archive, retrieve, and show the data for any state of the process at any given moment in time. This Special Report provides insights into how we manage, use, and incorporate data to protect the integrity of all values, measurements, and processes—as well as comply with regulatory mandates and guidances.

Subscribe to November / December 2017
Features
Mentoring is a hot topic these days. Do a quick Google search of the word “mentoring” and you’ll get some 95 million results. A narrower search, “mentoring an engineer,” will get you about 11 million results, or 12% of the first search. For even more...
InTouch
ISPE Japan’s Annual Meeting, always the leading event in the affiliate’s calendar, was especially festive this year as the group celebrated its fifteenth anniversary. Held 18 and 19 May at the Toyama International Conference Center in the mountainous...
InTouch
ISPE Thailand cohosted “Cleanroom Testing and Certification,” a joint meeting between the affiliate and the Thai Industrial Pharmacist Association on 2–3 May 2017 at the Ambassador Hotel Bangkok. The meeting drew 250 attendees—including 30 from the Thai...
Insights
Beginning in 1932, the US Public Health Service conducted an infamous research project—the Tuskegee Syphilis Experiment—designed to follow the course of untreated syphilis. The unwitting participants were poor African-American men in Alabama, who were...
Technical
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...
Special Reports
Data integrity continues to be a very hot topic for both regulators and the pharmaceutical industry. With the increased observations about data integrity in laboratories, could it be that analysts have changed how they do science in the laboratory? Are...
Special Reports
Before the advent of integrated computer systems, LIMs, HMI interfaces, comprehensive software, CGMP, BAS, process control systems, PAT, and the use of statistics, manual record keeping was fraught with errors—most of them unintentional. This led to...
Insights
Most companies leverage social media as part of their recruiting strategy, so if you don’t use it in your job search you put yourself at a huge disadvantage. First, determine your brand: How do you want others to see you? Who do you want to find you?...
InTouch
With more than 600 biotech and pharmaceutical companies and 700 medical device and equipment companies, the pharmaceutical industry in the San Francisco Bay Area is flourishing. In 2016 alone, biotechnology and pharmaceutical investment in California,...
InTouch
A delegation of pharmaceutical industry professionals and regulators from Russia met with ISPE leadership and staff on 20 July. The visit was arranged by the International Visitor Leadership Program (IVLP), a professional exchange program run by the...
InTouch
It’s a large subject,” admits Ferdinando Aspesi, when we ask him how the Global Pharmaceutical Manufacturing Leadership Forum (GPMLF) plans to address one of the hottest topics in the industry: the workforce of the future. The GPMLF is represented by 65...
InTouch
Rome’s Esposizione Universale Roma, or EUR district, has seen more than its fair share of history. Originally planned as the site of the 1942 World’s Fair under Italy’s prewar fascist regime, the uncompleted EUR suffered extensive damage during the...
Features
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 Global sales are growing at a rate of more than 8%, double the rate...
Insights
The end of a year, the start of a new job, a groundbreaking scientific development: These are events that give us pause, moments that help us transition to a new mind-set, focus, or even a new career. Managing these moments is as important as being a...