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.
★AUTOMATION CONTROL AND SENSING★
The ability to install anything in a sterile pharma production environment in less than 30 minutes is worth taking a close look at, so when Pepperl+Fuchs introduced its new aseptic operator work stations touting 30-minute or less installation, readers and editors took note. Its innovative caulk-free design facilitates speedy installation employing spring-loaded wall clamps to anchor the housing — even shallow wall-to-wall spaces and modular walls without deforming them. The door simply mounts to retractable hinges. From there, users just connect communication and power and lock the door.
Ready to deliver a double play, for the first time Seidenader has combined visual inspection with high-voltage leak detection in an automatic syringe inspection machine. According to Seidenader, such integration offers enormous advantages in terms of lower initial costs, easier handling and maintenance, smaller footprint and reduced training requirements for operators. Beyond that, all inspection results come from one single source. The HV inspection module is designed for a capacity of 36,000 syringes per hour and thus can also be integrated into the Seidenader high-speed inspection machine VI-S.
Downstream unit operations produce increasingly higher protein titers, yet floor space in downstream processing plants remains at a premium with buffer hold tanks, or totes, generally consuming significant floor space. That’s why, says Asahi Kasei Bioprocess, it developed the IBD 1K, the successor to the company’s flagship IBD Inline Buffer Dilution System. Ready to phase out oversized systems, large tanks and the rigors of manual buffer production in favor of an ergonomic pre-engineered solution optimized for platform adoption across different facilities? PhM editors thought you might. Now biopharma process technicians can accelerate buffer production while taking advantage of the system’s space-saving format.
Sartorius Stedim Biotech’s new Sartocheck 4 plus Bag tester is the first device to allow reliable pre-use testing of single-use bioreactors after installation. Based on proven pressure decay measurement methods, the bag tester directly responds to the industry’s demand for increased security and quality assurance across single-use component-based processes. At the heart of it is its unique, patented fleece, which is inserted between the plastic film of the BIOSTAT CultiBag STR and the bag-holding device of the tester. According to Sartorius, the fleece reduces environmental heat transfer and eliminates the effects of masking of any potential pinholes.
Xcellerex’s FlexFactory is a modularized, integrated biomanufacturing platform designed to speed the deployment of new production facilities in as little as 12 months. The product portfolio provides easy scale-up to bioreactors as large as 2,000 liters — with full downstream purification through final bulk product — all on the same integrated, single-use flow path. Electronic batch records identify errors in real time allowing isolation of problems. FlexFactory CEM’s are based on traditional cleanroom standards.
★PACKAGING AND HANDLING★
With the new FHM 1000 Series, Bosch Packaging Technology introduces a semi-automated, modular laboratory device for liquid pharmaceutical filling operations particularly well-suited for laboratories conducting early clinical trials. According to Bosch, the unit’s filling parameters can be easily scaled-up to meet production goals; all relevant parameters specified in the laboratory can be seamlessly transferred to production machines.
MG America is set to introduce its Perfect Pack Beta 200 Vertical Sachet Machine to the U.S. at PACK EXPO 2013. Characterized by simple size changes and easy cleaning access, the Beta 200 can produce up to 160 sachets per minute. Operated by intermittent motion, the machine forms, fills and seals sachets ranging from 40-200 millimeters in width, 50-170 mm in length, and 0.1-100 milliliters in volume. The Perfect Pack Beta 200 contains dosers for powders, granules, pastes, liquids and wet wipes.
NJM Packaging will also be offering something new at PACK EXPO: Model 402 Final Touch Print & Apply Labeler. The 402, says NJM, offers simplified operation with fewer moving parts, a smaller footprint, reduced maintenance and easier installation. Applying vertical and horizontal labels to cases, cartons, bags and shrink-wrapped bundles at speeds up to 60 per minute, the 402 applies side labels, corner wrap labels and top labels using either a tamp or wipe-on applicator, as needed. It can be equipped for optional e-pedigree serialization, RFID tagging and other track-and-trace initiatives. NJM also designed the 402 Print & Apply labeler to be integrated with virtually any off-the-shelf print engine.
Viega’s MegaPress is the first system to use press technology for installing Schedule 5 to Schedule 40 black iron pipe. According to Viega, it makes secure water-tight and air-tight connections in less than seven seconds without welding. More than 200 fittings are available ranging in sizes from 1/2” to 2” that include elbows, couplings, reducers, tees, reducing tees, threaded adapters, unions, caps and flanges.
Characterized as the “next generation” of screeners, the Type DA 650 Vario cyclone screener from AZO has, according to the company, “reinvented cyclonic screening technology.” Innovative is the fact that, because of the built-in self dosing device, no additional upstream dosing unit is required. The dosing capacity can be adapted to specific process requirements by means of the frequency converter. To cope with a wide range of differing products, screening capacities or mesh sizes, the screener output can be adapted by combining different dosing modules with the screener module. The DA 650 requires no additional dosing unit and is completely extractable without the need for tools.
Pharma Technology Inc. showed off its new AIO Deduster and Tester System at INTERPHEX New York in April. Short for “All In One,” the AIO system builds upon the company’s PharmaFlex family of dedusters by offering turnkey peripheral devices as integrated solutions. Pharma Technology Inc.’s AIO Deduster and Tester S can be combined with the company’s deduster spirals, metal detectors and tablet tester. The tester can be positioned on any of three sides on the deduster’s base, and it offers push-fit cable-free connections for power and data storage.
Making its first appearance at INTERPHEX, Fette Compacting America demonstrated the FE35 Tablet Press which the company touts as offering the fastest changeover time in its class. Says Ciurczak, “Any press that can snap out more than 350,000 tabs an hour is pretty darn impressive!” The FE35 is a single rotary tablet press that can be fitted with up to 51 stations, enabling the production of, according to Fette, up to 367,000 tablets per hour. A new rotor design was also implemented for maximum yields, minimum product loss and easy changeover. Similarly, the turret can be removed from the press in 15 minutes; a procedure requiring the removal of only 10 components, without tools.
Gamlen’s GTP-1 Tablet Press was another standout at Pittcon. The device is the only one of its kind to be controlled by computer, thus helping to integrate informatics with the device and supporting tablet development and data capture. It promises straightforward process comparisons, as well as formulation and material analysis.
In 2013, Catalent Pharma Solutions acquired an exclusive license to market Redwood Bioscience’s proprietary SMARTag precision protein-chemical engineering technology for the development of advanced antibody-drug conjugates (ADCs). ADCs combine the targeted binding specificity and half-life benefits of monoclonal antibodies with the potency advantages of small molecule chemotherapy or therapeutic agents. ADCs are emerging as one of the fastest growing development areas in biologic anti-cancer treatment. SMARTag’s novel protein conjugation and linker technologies overcome the limitations associated with conventional protein chemistries that produce heterogeneous products with variable conjugate potency, toxicity and stability. The technology enables site-specific, controlled drug-protein conjugation and uses only naturally occurring modifications to proteins requiring minimal cell-line engineering.
Pharma Tech Industries was recently selected to handle filling, assembly and packaging services for a migraine relief medication administered through an innovative new method: a breath-powered nasal delivery system called OptiNose. The delivery system employs a novel means of easily administering drugs deep into the nasal cavity, enabling the treatment of both local and systemic diseases. The new technology offers a much-needed alternative to existing, poor-performing nasal sprays, as well as to tablets and injections.
Last fall Accelrys Inc. delivered to the industry its new integrated Accelrys Process Management and Compliance Suite of software products designed specifically to enhance product and process insight, facilitate collaboration and streamline product development from research through late-stage quality control and manufacturing. The software suite directly integrates with systems critical to development and manufacturing processes including LIMS, ERP, PLM and MES.
Rockwell Automation announced the release of its PharmaSuite v5.0 system for pharmaceutical and biotech production in July. Its goal? Setting new standards for manufacturing execution system (MES) performance in automation, risk management, cost reduction and regulatory compliance. According to the company, the new version delivers a single MES solution with the agility to integrate and streamline production not only across multiple production areas and product lines, but also from line to site level. The PharmaSuite v5.0 system includes improved integration with production equipment — including premier integration to the Logix control platform — and automated batch processing using the PharmaSuite Recipe Designer. The system automatically collects data directly from production equipment, provides automation set points, monitors automation events, and integrates process information into the electronic batch record to reduce the risk for human error that can result from manual data collection.
Version 13, the latest version of SIMCA — Umetrics’ software for Multivariate Data Analysis — packs a punch. This new release, says the company, includes a major overhaul of the interface, usability and graphics. The intuitive interface reduces the number of mouse-clicks for common actions, and eases the use of SIMCA.
★SUPPLY CHAIN TRANSPARENCY★
In May, Acsis Inc. announced “Serialization in a Box,” a complete turnkey solution that identifies, applies and captures the data needed to comply with California’s upcoming 2015 e-pedigree mandate. To create a turnkey enterprise serialization solution, Acsis combined its serialization software with material handling, vision and printing equipment. Acsis’ solution applies and captures serialization data at the unit, bundle, carton and pallet level, so pharmaceutical companies can comply with all domestic and international serialization mandates.
INTERPHEX visitors at Vaisala’s booth were impressed by the simplicity of the company’s CCL100 Cold Chain Logger, and so were the editors at Pharmaceutical Manufacturing. The simple, compact and disposable device records and monitors time and temperature for vaccines, pharmaceuticals, biologics, and other perishable products during distribution and short-term storage. What’s notable about the single-use CCL100 logger is that it eliminates the need for readers and proprietary software. The device breaks it down to three simple steps to compliance: 1) place the CCL100 data logger in the product or container; 2) press Start/Mark when it’s time to ship/at each stop; and 3) download the Logger via USB to automatically create a 21 CFR Part 11-compliant PDF report.
Complete Inspection Systems Inc. recently introduced an advanced 2D barcode for absolute product identification and brand protection — no Internet lookup required. According to the company, the HD Barcode is a revolution in data density, holding up to 703 kilobytes of secure, encrypted information. By incorporating the HD Barcode into the printed materials such as cartons, labels, or containers, pharma manufacturers can incorporate encrypted technology that allows any firm to positively identify products. The HD Barcode can be custom-configured to provide each manufacturer a unique private version of the code.
While attending the Global Pharmaceutical Manufacturing Summit, Red Bag Solutions’ medical waste sterilization platform jumped out as an innovator All-Star. It’s the only treatment technology available, says the company, that simultaneously grinds and sterilizes medical waste without hazardous chemicals, negative air emissions or odors. The relatively compact unit deploys either site-generated steam or a straightforward ozone regimen to sterilize the ground-up beakers or similar pharma waste items. In fact, the sterilized waste can be placed directly into the facilities compactor as ordinary municipal trash.