35th Anniversary Special: Reader Views on Changes in Pharmaceutical Manufacturing - Pharmaceutical Technology

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35th Anniversary Special: Reader Views on Changes in Pharmaceutical Manufacturing
Readers point to quality by design as having a significant influence on manufacturing and drug development during the past decade.

Pharmaceutical Technology
Volume 36, Issue 7, pp. 59-60

Dosage form development, manufacturing, and analytical technology

Figure 3: Which of the following breakthroughs has contributed the most to advancing oral drug delivery or oral product forms?
We also asked readers to evaluate which technology has contributed the most to advancing oral product forms or oral drug delivery (see Figure 3). The two areas that received the highest responses were orally disintegrating tablet technology (24%) and nanotechnology-based applications (21%).

Figure 4: During the past decade, what has been the most significant advance in sterile manufacturing?
Advances in isolator technology and systems was cited as the most significant gain in sterile manufacturing, being cited by 36% of respondents, making it the highest ranked change in this area (see Figure 4). QbD followed at 23%.

Figure 5: What would you identify as the most significant advance in analytical instrumentation and methods development during the past 5–10 years?
Reflecting again the importance of QbD, 30% of respondents identified process analytical technology (PAT) as the most significant development in analytical methods development and instrumentation (see Figure 5). PAT tied with greater throughout in chromatographic methods as the most importance advance.

Looking ahead

Figure 6: Looking forward 10 years from now, what do you think will be the most significant change in drug development and manufacturing?
We also asked readers to identify what they think will be the most significant change influencing the future of drug development and manufacturing (see Figure 6). More than one-third (36%) of respondents said the move to personalized medicine through the increased use of diagnostics with traditional pharmaceuticals. More than one-quarter (29%) said the rise of biologic-based drugs in drug pipelines and commercial product portfolios followed by fuller adoption of QbD (22%).


1. FDA, Pharmaceutical CGMPs for the 21st Century—A Risk-Based Approach, Final Report (Rockville, MD, 2004).


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