November / December 2020

Plenary session at the 2019 ISPE Europe Biotechnology Conference in Brussels in September 2019.
Features
2019 ISPE Europe Biotechnology Conference: Industry Transformations

As biopharmaceuticals have become a major part of the pharmaceutical industry, we have witnessed significant transformations in product development, strategy, technology, and operations. This ongoing transformational process was the main theme of the fourth annual

Current State of Oligonucleotide Therapeutics
Features
Current State of Oligonucleotide Therapeutics

Oligonucleotides are a relatively new class of drugs, composed of natural and synthetic nucleotides, which primarily include small interfering RNA (siRNA), micro RNA (miRNA), and antisense oligonucleotide (ASO). These molecules achieve therapeutic effects through RNA interference, degradation, or splice-modulating pathways.1

  • 1Weng, Y., H. Xiao, J. Zhang, X. J. Liang, and Y. Huang....
Figure 1: Cell therapy life cycles.
Features
Flexible Facility Design for Multiple Cell Therapy Processes

In many critical ways, the design of facilities for multiple cell therapy processes is unlike the design of conventional pharmaceutical facilities. This article surveys several of the key issues to consider when designing facilities capable of manufacturing multiple cell therapies, including regulatory definitions, product life cycles, processing systems, relevant cell therapy technologies and...

Cell & Gene Therapy Facility Design Using Simulations
Features
Cell & Gene Therapy Facility Design Using Simulations

Designing new facilities for cell and gene therapy manufacturing is a challenging task given the many uncertainties in this industry sector, including varying potential demand for any given new therapy, evolving platforms and technology, questions about equipment reliability, learning curves for analysts and operators, possible sourcing issues, and variable lead times for key raw materials....

Young Professional: LeAnna M. Pearson
Insights
Young Professional: From Young Professional to Emerging Leader

As this is my last Young Professional (YP) column for Pharmaceutical Engineering®, I wanted to start with a quote from Winston Churchill that I feel summarizes my two-year journey as the International Young Professional Chair: “Success is not final, failure is not fatal: it is the courage to continue that counts.”

Frances M. Zipp - Board Chair
Insights
Message from the Chair: That Was the Year That Was

Given the events that have transpired over the last 12 months, I have penned the title of my final column as ISPE Chair to reflect the temperament of our times. Coincidentally, and please pardon my digression, the title also happens to be the name of a hit album of topical songs by Tom Lehrer, recorded live in July of 1965 at the “Hungry I” nightclub in San Francisco, California.