What is innovation? It’s one of those circuitous philosophical questions that can be debated endlessly. Whether the word conjures images of Steve Jobs or Thomas Edison, innovation is happening every day in the pharmaceutical industry. Patients’ lives depend upon your innovations. But how innovative are the tools that are being introduced to help you do your jobs every day?
This article briefly highlights some of the new products that you, the readers of our magazine, have found to be most innovative. One key requirement for consideration was that a nominated technology must have been formally introduced to the market after January 1, 2010.
Each nominated technology has been put under the scrutiny of members of our editorial advisory board and other industry experts, who have helped us separate wheat from chaff. We received over 50 nominations to start with, and with the help of advisors have whittled them down to those listed below.
This is not an all-inclusive list. If you feel there’s a technology out there that deserves notice, let us know. Here are our reader-nominated 2012 honorees:
Microbiology is an area of drug manufacturing that has seen rapid innovation in recent years, led by the proliferation of rapid microbiological methods (RMM). Processes for tracking and identifying microbes that used to take weeks can now be done in days. Not surprisingly, many new technologies are joining the RMM bandwagon, making it harder and harder to decipher which are truly innovative.
Even the experts we consulted were not in full consensus, and yet here are the nominated technologies they see as difference-making:
BioTrak Real-time Viable Particle Counter (TSI, Inc.): “This is truly innovative as it counts viables, non-viables and collects the viable organisms for subculture,” says one of our experts. It’s this ability to collect the counted viable organisms that distinguishes the BioTrak, the expert says. Another concurred that what separates this technology is the cell capture filter.
On paper, says another microbiologist, real-time viable particle counting has great potential. In practice, he says, “issues relating to the discrimination between ‘live’ and ‘dead’ cells needs to be ironed out (non-microbiological fluorescent particles).” Another issue is how detection by the instrument relates to colony forming units and how this, in turn, relates to regulatory guidance. So while the technology is promising, he says, “some of the philosophical questions in relation to regulations require careful discussion.”
A technology that our experts like is the PLEX-ID Molecular System from Ibis Biosciences (now part of Abbott). PLEX-ID has been around for a few years, but is just gaining market penetration in the U.S. and was only recently introduced into the European market. “The ability to detect multiple microorganisms moves the art of microbial identification forward and can deliver significant time savings, moving past the need to obtain a single culture,” says one of our experts. “The sample throughput and time-to-result features (of up to 250 samples per day) is impressive and would fit the needs of most busy laboratories. Furthermore, the size of the database is comprehensive and should match most applications.”
Finally, one of our experts nominated Pall’s GeneDisc Rapid Microbiology System, and others concurred. The GeneDisc uses polymerase chain reaction (PCR) technology and consists of three steps: a DNA Extractor for sample prep, a disposable Plate for assays, and a Cycler which performs the qPCR assay and automatically records results (without operator intervention).
“This technology is new and innovative,” says one micro expert. “The automation of the system is the real advance.” The GeneDisc is well-suited for a Microbial Limits Test. “The advantage is the speed and the accuracy, whereby specific pathogens can be targeted and detected,” another expert says.
Analytical and Monitoring Devices
With the encouragement of process analytical technologies (PAT) by FDA and other regulatory bodies, technologies that manufacturers have been tinkering with for decades came in vogue. “We’ve been doing PAT for years,” is a common refrain. But only recently has it been given its due respect by pharma’s higher-ups. As such, there’s been a wave of new PAT and related technologies of late.
One is the ImMix Micromixing Hyperspectral Imager from Middleton Research. Hyperspectral imaging (HSI) is the combination of spectroscopy and digital imaging. A hyperspectral image contains many spectra, one for each individual point on the sample’s surface, providing details about the spatial distribution of materials in a sample. It is particularly well-suited to analyzing solid drug such as films, blends, and tablets, either on-line during manufacturing or in lab formulation development. The ImMix can be a tremendous help for product development, says one of our consulted experts.
Another Innovations honoree is the Eyecon 3D Particle Characterizer from Innopharma Labs. The Eyecon is a real-time 3D imager developed specifically for pharma applications such as milling, granulation, and spheronization. Information on particle shape and surface topography is included in automatically generated batch reports and size distribution histograms. Whether for real-time or archival info, one of our advisors noted, this product provides an excellent 3-D presentation of data.
Another favorite of our review panel in this category was the picoSpin-45 miniature NMR Spectrometer, from picoSpin of Boulder, Colorado. For research or manufacturing, only 20 microliters of sample fluid is needed to obtain a spectrum. The company bills the product as “100 times smaller and 10 times less expensive than any previous NMR spectrometer.” While we can’t verify this statement, our experts agree that represents a capability leap compared with existing technology.