Evolutionary or revolutionary, technical innovation is supporting new gains in pharmaceutical manufacturing and processing efficiency. That is, the technologies are available to help achieve these gains, but only if these players get a chance to get out of the bullpen and have their turn at bat. Let's be honest, it's been a long time since Pharma's leadership in manufacturing excellence was accepted as fact, but there are plenty of drug manufacturers out there (as well as their design, engineering and technology suppliers) who beg to differ.
But it's a new year and another season entirely, one spanning an incredibly dynamic, complex global marketplace. The pace of change and the market's dynamics are prompting fresh capital investment in equipment and facilities, especially in the Bio and Contract Pharma sectors. Pressure on global players to improve quality is intensive. Excluding Japan, Asia's Generic Pharma business is spending more than ever to gain compliance and subsequent relief from regulators. All of Pharma's big teams want to play in this World Series, but to do it successfully they have to be competitive; and increasingly, to be competitive manufacturing operations have to be fit, flexible and agile enough to meet the market's challenges while beating other teams playing the field.
Pursuing competitive agility through operational excellence is a winning strategy most of Pharma's manufacturing-oriented leadership will recognize. The means to achieve competitive agility is increasingly coming from the Pharma industry's technology and system suppliers. Many companies are delivering technical innovation to support drug development and innovation. These innovators deserve to be recognized. What follows are this year's All-Star Innovators, technologies and systems introduced within the last 12 months that, based on their relative applicational and technical merits, were selected by Pharmaceutical Manufacturing's editors and reviewers to be on this year's All-Star Innovators Roster. Just like in the big leagues, products and companies (players and teams) were featured on their own baseball card, complete with performance and other stats.
Take a look at who made this year's roster; there's bound to be something able to help make your process or operational task a winner for your organization.
ANALYTICAL AND MONITORING DEVICES
AMETEK Crystal Engineering's HPC40 Series hand-held calibrator leads off, ready for on-the-run calibration tasks around the plant. Because the HPC40 Series is the world's first mA loop calibrator that is fully temperature compensated from -20o to 50oC, it can deliver the same accuracy whether measuring pressure, current, voltage or temperature. The HPC40 can typically replace several gauges or calibrators and offers a full-color display paired with a new user interface that offers a shallow menu structure allowing tasks to be performed quickly and intuitively.
To help users gain a better understanding of biologic formulations earlier, Malvern Instrument's Zetasizer Helix combines Raman spectroscopy with Zetasizer dynamic light scattering (DLS) technology to conduct highly detailed protein aggregation mechanism studies. According to Malvern Instruments, a key priority for the industry is obtaining a greater understanding and control over the formulation process, a need exacerbated by the increasing adoption of QbD. By allowing users to fully scope protein behavior within a formulation, the device provides insight at the molecular level as to which variables trigger, for example, oligomerization and aggregation, this supporting a QbD approach.
Primex Wireless offers a pervasive, flexible wireless solution with its OneVue Intelligent Monitoring Platform. The platform, says Primex, is unique in that the data generated by sensors is tied to the room, physical equipment (such as refrigerators) or inventory (such as pharmaceuticals) being monitored, rather than to the sensor. As a result, OneVue delivers comprehensive, historical data trails for compliance audits, preventative maintenance, benchmarking, cost comparisons and more - all without requiring users to merge records each time a sensor is changed or assets are moved.
Like the bat is to baseball, so is Thermo Fisher Scientific's Gemini handheld FTIR and Raman analyzer; that is, it's essential, portable and goes where the game is. According to Thermo Fisher, Gemini analyzers require minimal training and are easy to use. The innovative design combines FTIR and Raman spectroscopy in a single, lightweight but rugged handheld instrument that delivers lab-quality analysis on demand. For those substances identifiable by Raman and FTIR, the scanner provides comprehensive analysis, delivering more actionable information to the operator. Switching between analysis techniques is fast and easy using the tactical keypad or touchscreen.
Unified to simplify chromatographic separation and analysis, the Nexara UC from Shimadzu Corp. eliminates the need for complicated sample pre-treatment and enables highly reliable and stable analysis of delicate samples that are prone to oxidation or dissociation if exposed to air. Fully automated, Shimadzu's system can sequentially analyze up to 48 samples via automatic extraction and chromatographic separation combined with high-sensitivity detection of targets by mass spectrometry. According to Shimadzu, the automated extraction and chromatography is achieved using a mobile phase of supercritical fluidic carbon dioxide (that exhibits the solubility of liquids and diffusivity of gases) into which alcohol and other such organic solvents are added.