Industry and regulatory organizations agree that the current focus on product quality will play a major role in shaping pharmaceutical
development in the future. Key to this assessment of quality are the methods and technologies in pharmaceutical analytical
testing. David Higgs, Business Development Manager, Malvern Instruments says "To meet the needs of pharmaceutical manufacturing
in the future, analytical testing for pharmaceutical products must change to provide real performance and quality information.
Analytical methods will be used online and at line, but knowledge about what parameters must be monitored must first be developed
in a laboratory setting. In other words, it doesn't make sense to put an analyzer on line if you aren't assured that the parameter
you will be measuring somehow impacts product quality. Methods are getting faster to provide more realistic sampling statistics,
and there is also an emphasis on nondestructive testing, which enables the analysis of more samples. Multifunctional capabilities
are important, but at this point can probably be provided by multiple instruments in series, rather than on a single instrument
(IMAGE: PHOTOS.COM/MELISSA MCEVOY)
One important challenge in the future will be to extract meaningful information from the increased information gained from
advanced technologies. Linda Kidder, product manager, Chemical Imaging Systems at Malvern Instruments, predicts "Advanced
technologies will provide information that simply is not attainable currently. As more information is obtained, understanding
critical to quality parameters will change. And specifications for testing will focus on those points that matter, not just
those points that can be measured."
One promising technology already poised to take a key position in the industry is near infrared chemical imaging (NIR-CI).
This technique provides product quality information and is a formulation development tool for the rapid and nondestructive
analysis of intermediate and final pharmaceutical products. "Characterizing the spatial distribution of chemical components,
[this approach] provides a chemical imaging fingerprint that shows which manufacturing method will deliver the highest quality
product. Once determined in a research and development setting, this product fingerprint can transition to a quality assurance
and quality control environment, where products can be evaluated for 'quality' based on this image metric," says Kidder.
"Particle characterization continues to be critically important in the pharmaceutical industry, from protein size and conformation
analysis at the discovery stage, right through to on-line analysis during manufacture," adds Higgs. "The industry and its
regulatory bodies continue to require more, increasingly sensitive and precise, information, driven by the ever-present need
for efficiency, profitability, and safety. As a result, there is a growth in demand for techniques that extend particle characterization.
It is now recognized that measuring the particle size and shape distribution of many raw materials used to manufacture a pharmaceutical
product is important in quality control. From an intellectual property perspective, this information can be used to tighten
the specification on a particular product and make it difficult to replicate. Many companies now write both size and shape
specifications into patents."
Maribel Rios, senior editor,
Industry experts give their predictions for the next 30 years. Read Editor-in-Chief Michelle Hoffman's introduction here. See what's next in:
Strategy and Regulation