All-Star Innovators 2014

Pharma’s tech bench gets deeper with an All-Star lineup ready for the big leagues

By Steven E. Kuehn, Editor-in-Chief

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Waters ionKey/MS System integrates UPLC separation into the mass spectrometer for improved sensitivity and unparalleled compound separation and detection — something that reduces solvent consumption and costs and simplifies the user experience. Containing fluidic connections, electronics, ESI interface, a column heater, eCord Intelligent Chip Technology and 1.7 micron UPLC grade particles packed inside a 150 micron I.D. channel, the ionKey/MS System was Merck Beta tested revealing a >60-fold increase in sensitivity for GLP-1.

AUTOMATION CONTROL AND SENSING
Endress+Hauser continues to intervene at critical points in manufacturing and process control and data environments, and its CM44x Liquiline Multichannel Transmitter is a strong individual contributor to processing trains via EtherNet/IP. One CM44 transmitter in play allows access to many parameters and accepts inputs down to the sensor level, including sensor condition and diagnostics. Traditionally, devices measuring and controlling process variables rely on a process instrumentation network to transfer data, while other devices within the plant work on a completely different network. By improving this complex, multi-tier networking strategy with one standard network architecture — EtherNet/IP — users have better access to real-time information. This improves the ability to monitor overall performance, troubleshoot out-of-margin conditions and minimize downtime.PM1406 EndressHauser InnovateCard

Diverse pH and ORP sensing applications across Pharma and chemical process system piping require a tough and smart player to get the job done. With its rugged Ryton body material, Georg Fischer Piping Systems’ DryLoc Sensors deploy a positive connector system to indicate a solid, water-tight connection and resist moisture/dirt intrusions. The sensors mount into standard Signet 0.50-inch to 4-inch fittings as well as into GF tees and reducing tees of ¾ inch or larger. The installation versatility makes virtually any manufacturer’s sensor simple and easy to replace when coupled with the Signet 2760 DryLoc connector, which can hook up to other manufacturers’ instruments.

BIO PROCESSING
Often innovation comes from understanding there’s a gap and filling it. ASI Life Sciences engineers understood that without an available high-capacity, single-use heat exchanger, manufacturing engineers were being forced to choose one of two sub-optimal options: Insert a stainless-steel heat exchanger along with its incumbent CIP/SIP infrastructure or use a jacketed mixing tote or similar technology as a stop-gap solution. Certainly not ideal. ASI’s DHX Single-Use Heat Exchanger now offers a purpose-built solution by combining the heat transfer properties of a high-capacity plate and frame heat exchangers with the advantages users can leverage from its single-use configuration. ASI’s system offers advantages for cell culture at the manufacturing scale, allowing engineers to build temperature control into their process without having to sacrifice the benefits of single-use.

On deck last September and already bringing efficiencies to downstream single-stage clarification are EMD Millipore’s Clarisolve Depth Filters. With higher titers coming from today’s upstream bioreactors, conventional approaches have posed a challenge to clarification, that is, until now. Clarisolve depth filters eliminate the need for centrifugation, which enables implementation of a fully single-use process train and reduces pre-use flushing requirements. This technology was developed to address the shortcomings of traditional downstream clarification approaches when processing high cell density and high-product titer cell cultures.

Any process operation is likely well supported by automating manual tasks. Parker domnick hunter offers its SciLog SciFlex Filter and Dispense System, a downstream solution that automates final bulk filtration and container filling, a step previously performed in a manual fashion within a vertical laminar flow cabinet. The system can perform manual filtrations, constant pressure, constant flow rate or the company’s R/P Stat Method, a hybrid method that maximizes filtration capacity. Playing for Fujifilm Diosynth Biotechnologies, the installation of the SciFlex Filter and Dispense System into the company’s cGMP manufacturing was a critical success factor in achieving compliant, right-the-first time manufacture of biologic pharmaceuticals, according to the biotech firm.

Single-use systems rely most on the disposable vessels at their heart, and Sartorius Stedim Biotech has developed its Flexsafe Single-Use Family of scalable range bags to perform better. Flexsafe enables the implementation of single-use bioprocessing throughout all steps of drug manufacture using a single polyethylene film. The innovative concept addresses key industry requirements for future-proof single-use manufacturing of commercial vaccines and drugs. The optimization of the resin formulation, the complete control of raw materials, the extrusion process and the bag assembly guarantee lot-to-lot consistent cell growth performance. Furthermore, batch-to-batch consistent extractables and leachables profiles support drug manufacturers throughout the entire lifecycle of modern biological treatments.

PACKAGING AND HANDLING
Glass ampoules, vials and other vessels have been on Pharma’s team a long time and possess many superior qualities. However, commercial-scale handling of glass in Pharma filling and handling operations is prone to create contamination issues from (relatively) rough handling. Garvy Corp.’s Infinity RX 36 Table Top Accumulator is a potential trade for traditional rotary table or turntable accumulators in product-handling environments. The Infinity RX 36 can out-feed products faster than a traditional rotary table and with less pressure and no damage, says the company, and requires the same footprint as a traditional rotary table while greatly reducing the pressure and noise associated with rotary table accumulators.

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