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: