Thomas Edison equated genius as “one percent inspiration and 99 percent perspiration.” Perhaps this is the formula for innovation as well, something that there seems to be no shortage of in the pharmaceutical manufacturing industry of late. There’s a distinct movement by many of the industries’ suppliers to introduce (some say overdue) innovative technologies that deliver practical, needed efficiencies into the drug manufacturing continuum. If one is looking closely, especially those operational and manufacturing managers looking for cost and performance gains, it soon becomes apparent that technology suppliers have applied healthy doses of both inspiration and perspiration in pursuit of technologies that Good Manufacturing Practice-based operations and Quality by Design processes are demanding.
Certainly not a comprehensive list, but what follows are technologies and systems introduced within the last 12 months and, based on their relative technical and innovative merits, were chosen to be on this year’s All-Star Innovators team. Because so many were brought to our attention, we offer some of the best examples here, but Pharmaceutical Manufacturing’s editors will be highlighting more “All-Star Innovators” online at PharmaManufacturing.com throughout the coming months.
Think something should make the team? Email us and let us know. For now, here are the All-Star Innovators for 2013, ready to help Pharma make the big plays in the market and deliver safer, more effective therapies to consumers.
★ANALYTICAL AND MONITORING DEVICES★
Advantest has been innovating in THz-based spectroscopy space and recently expanded the application coverage of its TAS7500 Series of spectroscopic imaging systems with two new systems: the TAS7500SU for wide-band coverage, and the TAS7500SL for low-frequency coverage. Advantest is also offering a new transmittance polarization analysis module. According to Advantest, the new systems and module expand the range of applications for the TAS7500 in pharmaceutical and other settings covered by existing systems, while also delivering the ability to analyze the polarization characteristics of samples.
EMD Millipore’s Mobius FlexReady Solutions for TFF and Chromatography are designed to optimize a given product’s manufacturability and accelerate time to clinic. Smart Flexware single-use flow pathways deliver equivalent or better performance to that of traditional stainless-steel systems while maximizing system flexibility, says the company. Smart Flexware assemblies are easy to install, reducing the risk of operator error and challenges typically associated with installing single-use flow paths. Additionally, the flow path reduces dead-legs and moving parts, decreasing the risk of contamination.
According to readers, when it comes to biopharma processes, cell growth is one of the most critically needed measurements in fermentation processes — it is also one of the most difficult and unreliable values to measure. Endress+Hauser’s OUSBT66 sensor for cell density measurement uses near-Infrared (NIR) light absorbance technology to generate real time, in-situ cell production measurement. Rapid and accurate measurement of cell growth activity in cultures is critical to identify the end of the log growth phase and the achieving of stationary phase.
Contributing Editor Emil Ciurczak likened Pie Photonics’ Pie-in-a-Box, no-moving parts, no scanning elements, mobile interferometer technology to a “Swiss Army Knife.” Designed to measure spectral content via Fourier Transform instruments, the system is available with a 400 nm-wide spectrum within the 400 nm to 1000 nm range. It uses a CCD line camera and can be configured to operate with other line arrays.
Thermo Scientific chose Pittcon 2013 to introduce its new Nicolet iS50 FT-IR spectrometer. The unit is engineered to deliver a powerful materials analysis workstation that allows users to extract information with minimal input, especially when coupled with its optional modules. Notable is the fact that the iS50 is the first research-grade spectrometer with one-touch operation, purpose-built accessories, and integrated analytical software capabilities to deliver an all-in-one materials analysis platform that maximizes laboratory productivity.
Many find liquid chromatography (LC) is the gold standard for quantitative measurement in quality control at many pharmaceutical organizations. Unfortunately, its analysis time used to take too long to generate results for manufacturing. Now, however, that’s changed. One commentator put it like this: “At last, a ULPC unit for the factory!” The PATROL UPLC Laboratory Analyzer from Waters Corporation provides real-time quantitative analysis of chemical reactions in process development and optimization laboratories. Waters’ UPLC system is a scalable solution that enables customers in process development, process scale-up, pilot production and full scale manufacturing to leverage UPLC technology to monitor and control a process.