Dosage form development, manufacturing, and analytical technology
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
Figure 3: Which of the following breakthroughs has contributed the most to advancing oral drug delivery or oral product forms?
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 4: During the past decade, what has been the most significant advance in sterile manufacturing?
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.
Figure 5: What would you identify as the most significant advance in analytical instrumentation and methods development during
the past 5–10 years?
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%).
Figure 6: Looking forward 10 years from now, what do you think will be the most significant change in drug development and
1. FDA, Pharmaceutical CGMPs for the 21st Century—A Risk-Based Approach, Final Report (Rockville, MD, 2004).