What's Next In: Analytical Testing

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 platform."

(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,

Pharmaceutical Technology

Industry experts give their predictions for the next 30 years. Read Editor-in-Chief Michelle Hoffman's introduction here.