Home runs are getting harder to come by in the pharmaceutical industry and drug makers know it. Innovation writ large for Pharma used to mean funneling, stadium-filling amounts of money into research and development (R&D) efforts tied to finding the next blockbuster therapy and afterwards, reaping the rewards of its patent-protected profitability. For most of Pharma’s history, those successes fueled even more profligate research spending, dollars which not only financed the development of new winners, but also plenty of losers as well. But in the wake of patent expiries (and an ever-shrinking pool of large-class disease categories), this “Blockbuster Quest” business model’s being traded for a leaner, more cost-effective R&D and manufacturing strategy designed to focus drug discovery efforts and accelerate the time it takes to get a solid hit, take it around the bases and score a run.
Gaining such competitive agility is increasingly coming from the Pharma industry’s technology and system suppliers. These companies are fielding some pretty impressive players to support big-league Pharma-style innovation. Fortunately, innovation is a competitive driver for Pharma technology providers as well, and their R&D efforts continue to deliver game-winning solutions ready to drive costs out and efficiencies in to drug manufacturing operations. 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 Roster. Just like in the big leagues, each player, er, product is highlighted by its own card, complete with performance and other stats. What follows are excerpts from those cards, but to view them in their entirety visit our All Star Locker Room. For now, though, take your seat, grab some peanuts and find out which ones might have the potential to be on your team.
ANALYTICAL AND MONITORING DEVICES
Cobalt Light Systems’ RapID developed its competitive edge via its patented Spatially Offset Raman Spectroscopy (SORS) technology, which permits a high-quality Raman spectrum to be measured through the thick, unopened layers of packaging. Most players know significant time and resources can be spent on verifying the identity of raw materials. Accurate ID of these materials is essential, but time consuming, expensive and resource intensive. RapID allows ID through unopened plastic containers for growth media and brown glass bottles for sterile liquids. According to Cobalt, sacks of lactose can now be identified through a multilayer paper sack in 20-30 seconds without needing to open or sample the sack.
Most understand that if you have a player who can execute on fundamentals a little bit faster and more accurately, it’s likely it can make a winning contribution to an optimized process strategy. GE Analytical Instruments’ got one, the Sievers M9 Total Organic Carbon (TOC) Analyzer. Designed to measure TOC in a broad range of samples from ultrapure water to process waters, the M9 is able to measure TOC and conductivity simultaneously, and provide accurate results in only two minutes.
Prozess Technologie developed an interesting approach that drives a bit of complexity and a lot of cost out of spectroscopic measurement with its REVEAL Measurement Appliances. This in-process spectroscopic measurement tool confirms blend conformity in real time and is easily deployable at a price that is well below industry norms. The company refers to its devices as “appliances” because unlike other measurement platforms, the unit is a single measurement device, eliminating the need for labs and scientists while delivering an accurate measurement for batch-based and continuously processed compounds. REVEAL is designed to work in virtually any manufacturing environment including hazardous materials and provides data that is accessible anytime via wired and wireless methods.
Need a player who can deliver material ID wherever it’s needed? Rigaku Raman Technologies has one ready to run the base line. Its Progeny Material ID Handheld system offers bench top analytical performance in a rugged, ergonomic and IP-68 sealed enclosure. Progeny’s fully customizable workflow software is 21 CFR Part 11 compliant, and its fast quad-core processor manages demanding search and quantification algorithms without requiring remote desktop work routines. An innovative 512-pixel InGaAs detector delivers improved resolution, analytics and signal to noise, handling the most challenging mixture analyses.
Improving HPLC/UHPLC method development productivity is an optimal strategy to speed drug development operations. Shimadzu Scientific Instruments introduced its Nexera Method Scouting System at Pittcon 2014, where it was recognized as a stand-out performer. Equipped with two pumps — each with a quaternary valve — Shimadzu’s system allows analysts to run binary gradients with 16 different solvent pairs. When combined with a robust, high-pressure resistant column selection valve, which holds up to six conventional or UHPLC columns, the system can investigate up to 96 unique separation conditions per sample. A transfer program allows ultra-high-speed conditions to be transferred to conventional conditions, making the system suitable for both R&D and QA/QC applications.