March / April 2019

Pharmaceutical Engineering March / April 2019

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In recognition of the growth and importance of generics to the pharmaceutical market, Pharmaceutical Engineering takes a look at what’s happening in four global markets: India, China, Japan, and the Philippines..

Generics: Industry Perspectives from Four Locales

Cover: In recognition of the growth and importance of generics to the pharmaceutical market, Pharmaceutical Engineering takes a look at what’s happening in four global markets: India, China, Japan, and the Philippines.

Identifying Global Themes in Clinical Study Participants’ Experience with Investigational Medicinal Products

Features: This article examines patient preferences in one facet of clinical research: the experience related to the use of investigational medicinal products (IMPs).

Biopharma Growth and Regulatory Perspectives

Features: The 2018 ISPE Biopharmaceutical Manufacturing Conference on 10–12 December in Huntington Beach, California, provided information about the future-oriented developments in the burgeoning area of biopharmaceutical manufacturing— and also shared insights into the achievements that are already underway. Regulatory perspectives on how new developments are being assessed were provided by several FDA speakers.

In This Issue

Insights
I hope 2019 is bringing exciting challenges and fulfillment to your personal and career goals. Like 2018, 2019 will have its uncertainties and opportunities but our industry will continue to evolve to bring new life-saving therapies to patients around...
Insights
It is an exciting time for the pharmaceutical and life sciences industries in Ireland. The country has firmly established itself as one of the world’s centers of excellence and the number one European location for pharmaceutical and life science investment. It is equally exciting for ISPE’s Ireland...
Insights
Teamwork and collaboration are becoming increasingly critical in today’s professional arena. The drive to produce innovative, disruptive products calls for interdisciplinary teams. To function effectively, these diverse groups require creative problem-solving, conflict resolution, and interpersonal...
Insights
Many members think of ISPE as a family of professionals, colleagues, and friends. Two of ISPE’s active members, George and Peter Millili, have taken this a step further; they’ve made ISPE part of their family.
Insights
I have always held myself to a high standard and kept high expectations for myself. I always thought that setting this high bar for myself would push me harder, make me better, and ultimately help me succeed. However, when I didn’t meet the expectations that I had set, I was so hard on myself. I...
Insights
Six women shared stories about building their diverse pharmaceutical industry careers, including challenges encountered along the way and their recommendations for other women in the profession, during a roundtable session on Women in Pharma®. The Roundtable opened the second day of the 2018 ISPE...
Features
India has become a major producer of generics drugs and is now the largest exporter of generics in the world.1 These exports go to over 160 countries, including the United States, Australia, Russia, and nations in Asia, the Middle East, Africa, and Latin...
Features
Over the past several years, Chinese regulatory authorities have signaled an increased awareness of the need to improve quality standards for both generic and biosimilar drugs. In 2015, the China Food and Drug Administration (CFDA) (now NMPA, National...
Features
In Japan, off-patented drugs are not always converted to generic drugs but may remain on the drug list as off-patented-drug products. These are customarily classified into three groups: patented drugs; off-patented drugs (“long-listed drugs”); and...
Features
It is the duty of the government to improve access to safe, effective, and quality medicines for its constituents. Various approaches are taken by different countries to achieve this; for the Philippines, the approach is through the active promotion of...
Features
This article examines patient preferences in one facet of clinical research: the experience related to the use of investigational medicinal products (IMPs). As patients have become more involved and informed in their healthcare choices, the “voice of the patient” has been increasingly incorporated...
Features
The 2018 ISPE Biopharmaceutical Manufacturing Conference on 10–12 December in Huntington Beach, California, provided information about future-oriented developments in the burgeoning area of biopharmaceutical manufacturing—and also shared insights into the achievements that are already underway....
InTouch
More than 200 attendees from manufacturers and key suppliers attended ISPE’s first European conference on aseptic manufacturing in the old capital of the Austro-Hungarian monarchy, Vienna. Austria is a hot spot for biopharmaceutical manufacturing with a number of global manufacturers or...
Technical
In recent years, the concept of quality in the pharmaceutical industry has evolved from the idea of testing the quality to designing the quality. The fundamental idea is very simple; it is necessary to understand the material and process variables that determine the final product’s quality from the...
InTouch
In conjunction with the 2018 ISPE Annual Meeting & Expo in November in Philadelphia, the ISPE Japan Affiliate held its annual pharmaceutical plant tour. The tour extended over four days from 29 October to 1 November. The group visited four US...
Technical
It is a common practice in the pharmaceutical and biopharmaceutical industries to execute a factory acceptance test (FAT) for equipment involved with various drug manufacturing processes. The FAT is a project milestone in purchasing good manufacturing practice–compliant equipment.
Technical
High-pressure liquid chromatography employing the multicolumn countercurrent solvent gradient purification (MCSGP) process principle has been developed as a novel purification technology for peptides produced by chemical synthesis. MCSGP offers a step change in efficiency compared to batch...