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Finesse Demonstrates TruFluor™ pH, a Single-Use Optical pH Sensor and Transmitter

March 6th,  2009 – Finesse Solutions, LLC, Santa Clara, CA, a manufacturer of measurement and control solutions for life sciences process applications, announced the technical demonstration of TruFluor™ pH, a single use optical pH measurement system, at Interphex in New York on March 17, 2009.

The TruFluor pH and temperature sensor is a single-use solution consisting of a disposable sheath, an optical reader, and a transmitter. The single-use sheath can be pre-inserted in a disposable bioreactor bag port, and irradiated with the bag, in order to both preserve and guarantee the sterile barrier. All wetted materials of the sheath are USP class VI compliant.

The optical reader uses advanced optical components including a large area photodiode that minimizes photo-degradation of the active sensing element. Similar to its dissolved oxygen counterpart, the TruFluor pH design has been optimized to provide accurate, in-situ measurement of pH using phase fluorometric detection in real-time. The temperature measurement leverages a 316L stainless steel thermal window embedded in the sheath, and provides a highly accurate temperature measurement that can be used as a process variable.

The TruFluor™ pH Transmitter optimizes the performance and reliability of the TruFluor pH Sensor, by enabling automatic entry of calibration and traceability data using RFID, diagnostics, and verification. The calibration and lot data are encoded on a gamma radiation resistant tagging of disposable sheath. The RFID data is automatically read by the transmitter, thereby eliminating the need to calibrate the probe and minimizing error and variability in the calibration.

“TruFluor pH completes our single-use sensor offering.  This product is optimized for accuracy, lifetime, and ease of use. We anticipate that the TruFluor sensor family will provide a unique, complete solution for single-use bio-processing applications” stated Finesse Solutions’ CTO, Dr. Mark Selker.

About Finesse Solutions, LLC
California-based Finesse Solutions, LLC, leads the way in developing new measurement and control technologies, in order to enable the transition to single-use systems, bring new capabilities to existing bioreactor platforms, and harmonize global bio-process information transfer.   Our current product family provides comprehensive measurement and control solutions for upstream processes in the biotech and pharmaceutical industries. For more information, please visit us at www.finesse.com.

Media: Barbara Paldus, 408-327-6623

Finesse Solutions Expands into State-of-the-Art Facility in San Jose, CA, USA

June 15th,  2009 – Finesse Solutions, LLC, San Jose, CA, a manufacturer of measurement and control solutions for bioprocess applications, announced its move from a facility in Santa Clara, CA, to a much larger facility in San Jose, CA. Finesse’s new address is 71 Daggett Drive, San Jose, CA, 95134. This move completes the consolidation of all Finesse departments from Irvine, CA to Silicon Valley.

The new building, which exceeds 20,000 square feet, features a class 10,000 clean room for the manufacture of Finesse single-use sensors, significant floor space for concurrent development and integration of single-use bioreactor systems, and designated areas outfitted for validation activities or factory acceptance testing. Additionally, space has been allocated for a future cell culture growth facility, in order to allow Finesse to further optimize and expand its product offering.

“Over the course of the last year, Finesse has expanded its business more rapidly than expected. We are pleased to announce that our new facility provides the capacity required to meet the ever increasing customer demand for our single-use sensor and automation products.” stated Barb Paldus, CEO at Finesse.

About Finesse Solutions, LLC
California-based Finesse Solutions, LLC, leads the way in developing new measurement and control technologies, in order to enable the transition to single-use systems, bring new capabilities to existing bioreactor platforms, and harmonize global bio-process information transfer.   Our current product family provides comprehensive measurement and control solutions for upstream processes in the biotech and pharmaceutical industries. For more information, please visit us at www.finesse.com.

Media: Barbara Paldus, 408-570-9011

Finesse Solutions Forges Agreement with Leading Biotechnology Company for Single-Use Technology Exploration

July 16th,  2009 – Finesse Solutions, LLC, San Jose, CA, a manufacturer of measurement and control solutions for biologics applications today announced a development agreement with Biogen Idec, Inc. (NASDAQ:BIIB) aimed at evaluating emerging technologies for single-use bioprocessing. These technologies include novel disposable sensors, software platforms, and control algorithms.

As part of the agreement, Finesse will provide prototype sensors, software, and systems for use by Biogen Idec in its bioprocessing platforms, and refine them for single-use applications. This collaboration allows state-of-the art technologies to be honed in actual use-case scenarios, and will leverage the expertise of both companies.

Dr. Mark Selker, Chief Technology Officer and founder of Finesse, stated, “We are delighted to have the efforts of world-class scientists at Biogen Idec help refine our technologies and focus our development. This will go far in helping to optimize our products using actual cell culture platforms.”

Dr. Thomas Ryll, Director Bioprocess Development at Biogen Idec, said “We are excited about the opportunity to work with Finesse on testing and improving new sensor technology for use in our high productivity process platforms.”

About Finesse Solutions, LLC
California-based Finesse Solutions, LLC, leads the way in developing new measurement and control technologies, in order to enable the transition to single-use systems, bring new capabilities to existing bioreactor platforms, and harmonize global bio-process information transfer.   Our current product family provides comprehensive measurement and control solutions for upstream processes in the biotech and pharmaceutical industries. For more information, please visit us at www.finesse.com.

Media: Barbara Paldus, 408-570-9011

Finesse Solutions Introduces the TruViu™ RDPDmini System

September 25th,  2009 – Finesse Solutions, LLC, San Jose, CA, a manufacturer of measurement and control solutions for life sciences process applications, announced the release of TruViu™ RDPDmini, a vessel utility tower system for laboratory scale bioreactors, such as glass vessels (<10L) or single-use rockers. The RDPDmini package extends the TruViu™ family into low-cost, small footprint applications. TruViu™ RDPDmini consists of a compact utility tower, and/or an optional gas manifold. TruViu™ RDPDmini brings the benefits of industrial automation reliability and scalability in a very affordable package. It is compatible with both DeltaV™ and Intel microcontroller system platforms. It interfaces easily with Finesse TruBio™ software (either DeltaV or Windows CE) to deliver optimal bioprocess control.

TruViu™ RDPDmini delivers the competitive advantages of increased performance, efficiency and reliability, reduced operating costs and improved ease of use in a future-proof package. It is designed to provide a flexible yet plug-and-play configuration, in order to maximize ease-of-use, simplify installation, and provide scheduled maintenance.

TruViu™ PLSS minimizes lab bench space while maintaining hardware capability at 3 pumps, 4 MFCs, 2 analog control loops, 2 analog inputs, and transmitters for critical process parameters as pH, dissolved oxygen and temperature. TruViu™ RDPDmini utilizes state-of-the art transmitters that enable sensor calibration algorithms, and will be upgradable to TruFluor disposable sensor technology for single-use applications.

According to Finesse Solutions VP Hardware, Dr. Alfy Riddle, "Our end users first asked for low cost and minimal footprint bioreactor controller systems, so we developed the modular TruViu™ RDPD. Then they asked us to further reduce size and cost for R&D applications. We responded by creating the TruViu™ RDPDmini."

About Finesse Solutions, LLC
California-based Finesse Solutions, LLC, leads the way in developing new measurement and control technologies, in order to enable the transition to single-use systems, bring new capabilities to existing bioreactor platforms, and harmonize global bio-process information transfer. Our current product family provides comprehensive measurement and control solutions for upstream processes in the biotech and pharmaceutical industries.

Media: Barbara Paldus, 408-570-9011

Single-Use Sensor Product Family Enters High Volume Production

January 11th,  2010 – Finesse Solutions, LLC, a manufacturer of measurement and control solutions for life sciences process applications, announced the production release of its single-use sensor product family: TruFluor sensors for dissolved oxygen or pH and process temperature, and TruTorr headspace pressure sensors. The product family is optimized for accuracy, lifetime, and ease of use. It is available on the Thermo Scientific HyClone BioProcess Containers for the Thermo Scientific HyClone Single-Use Bioreactor. Finesse single-use sensors are seamlessly integrated into the Finesse turnkey bioreactor system, either in single or redundant process configurations, having process volumes from 25L to 2000L. The sensors have also been qualified for use in cGMP applications.

The TruFluor sensors consist of a disposable sheath, an optical reader, a cable, and a transmitter. Their patented optical design is based on real time phase fluorimetry and uses a large area detector enabled by free space optics in order to eliminate photo degradation and drift. The TruFluor products also provide a co-located temperature sensor which is accurate enough to be used as a process variable. The TruTorr system consists of a disposable pressure sensor, a cable, and a transmitter.

Finesse sensors automatically compensate for temperature, and are pre-calibrated. Specifically, the calibration and lot data are encoded on a gamma-radiation-resistant memory chip that is integrated inside the sensor and follows it through production and sterilization. This chip is automatically read by the Finesse system once the disposable element is connected. All sensor wetted materials are animal-derived component free and USP class VI compliant; each sensor’s certificate of compliance can be downloaded from the Finesse web site.

All Finesse single-use sensors are pre-inserted in a disposable bioreactor bag port and gamma sterilized with the bag. As the sensor is pre-inserted during the bag manufacturing process, the sterile barrier is never broken; since the sensor and port form a unique, high surface area seal, media backflush and leakage, that are common with reusable sensor interfaces, are completely eliminated.

According to Finesse Solutions CTO Dr. Mark Selker, “Every aspect of our single-use product family has been engineered to allow the bio-process professional to focus on their process instead of problems. The fast ramp into high volume production of our products is the result of rapid adoption of our technology by the market leaders in bio-processing, but also general market recognition that our sensors provide a unique, complete solution for single-use upstream applications.”

About Finesse Solutions, LLC
California-based Finesse Solutions, LLC, leads the way in developing new measurement and control technologies, in order to enable the transition to single-use systems, bring new capabilities to existing bioreactor platforms, and harmonize global bio-process information transfer. Our current product family provides comprehensive measurement and control solutions for upstream processes in the biotech and pharmaceutical industries.

Media: Barbara Paldus, 408-570-9011

Justin Hutchinson Joins Finesse Solutions as Vice-President of Sales

June 15,  2010 – Finesse Solutions, LLC, a manufacturer of measurement and control solutions for life sciences process applications, announced the addition of Justin Hutchinson as its Vice President of Sales. Over the past two decades Justin has contributed to the advancement of new technology platforms within the bioprocess industry, and will leverage his experience and knowledge of applicable product platforms in his new role at Finesse. Most recently Justin was the Director of BioProcess Market Development, a technical sales leadership role at Thermo Fisher Scientific. Justin previously held management positions in operations, engineering, R&D, marketing and product management over a twenty year career with Thermo Fisher Bioprocessing container division, formerly known as HyClone.

At Finesse, Mr. Hutchinson will lead the global sales team in bringing both the TruBio bioreactor control platforms and sensor product families to the international marketplace, with a view to providing customers with turn-key upstream solutions. Mr. Hutchinson said, “I am very excited to join Finesse at this time. As the industry leader in controls and sensing technologies, Finesse provides a much needed product offering to a broad array of customers with whom I am very familiar. I truly look forward to working with the entire Finesse team. We are uniquely positioned to meet customer automation and sensor system needs as well as provide turn-key products and services involving both traditional and single-use bio-processing equipment.”

According to Finesse Solutions CEO Dr. Barbara Paldus, “We are delighted to welcome Justin to the Finesse executive team. With his extensive experience in single-use system markets and bio-processing technical background, he is the ideal leader for our sales team as they expand their reach internationally with our next generation of turn-key upstream products.”

About Finesse Solutions, LLC
California-based Finesse Solutions, LLC, leads the way in developing new measurement and control technologies, in order to enable the transition to single-use systems, bring new capabilities to existing bioreactor platforms, and harmonize global bio-process information transfer. Our current product family provides comprehensive measurement and control solutions for upstream processes in the biotech and pharmaceutical industries.

Media: Barbara Paldus, 408-570-9011

Finesse Introduces TruBio™ IOQ

December 4th, 2007 - Finesse Solutions, LLC, Santa Clara, CA, a manufacturer of measurement and control solutions for life sciences process applications, announced the general release of its TruBio™IOQ package. TruBio™ IOQ is designed to take the guesswork out of validation and to complement thefully configurable TruBio™ operating system (TruBio™ OS).

Traditional validation of control systems can be expensive and time consuming, especially when new documents are created by external validation service contractors. The TruBio™ IOQ package provides all of the protocols needed to validate the maximum process configuration of a specific bioreactor type. By simply choosing the relevant sections and following the pre-written test procedures, end users can complete their installation and operational qualification.

Project managers utilizing TruBio™ IOQ can save valuable project time by eliminating the need to develop validation protocols and by minimizing the validation efforts traditionally found in implementing a new control system. With TruBio™ IOQ, customers can quickly validate TruBio™ OS functionality, minimize down time and improve predictability of the installation schedule.

Upon completing TruBio™ IOQ, users will establish documented evidence assuring that TruBio™ OS meets all user requirements and design specifications. TruBio™ IOQ provides objective evidence that TruBio™ OS performs consistently and accurately per its intended use in the bioprocess application. TruBio™ IOQ follows and incorporates established GAMP4 guidelines to ensure that TruBio™ OS is compliant with FDA’s Title 21 Code of Federal Regulations Parts 11, 210 and 211. TruBio™ IOQ also ensures that the TruBio™ OS will function as specified in cGMP and cGLP environments.

“The days of long and expensive validation are over. TruBio™ IOQ will streamline Installation and Operational Qualifications and at the same time be affordable!” says Yeng Vang, validation manager at Finesse.

About Finesse

California based Finesse leads the way in developing new measurement and control technologies,in order to enable the transition to single-use systems, bring new capabilities to existing bioreactor platforms, and harmonize global bio-process information transfer. Our current product family provides comprehensive measurement and control solutions for upstream processes in the biotech and pharmaceutical industries.


Biomedical Resources International

April 19, 2007 – Finesse Solutions, LLC, Santa Clara, CA, and Biomedical Resources International,Northborough, MA, have signed a distributor agreement for Finesses’ TrupH™, TruDO™, TruCell2™,TruTransmitter™, TruBio™ OS, TruLogic™ and TruViu™ products for the Life Science market in theNortheast from Maine to Maryland.

The combination of Biomedical Resources years of experience as a supplier of best-in class equipmentto the Life Science market and Finesse’s growing role as a manufacturer of innovative solutions forboth measurement and control in Life Science applications promises to provide end-users with theproducts and support they require to optimize their process while reducing their costs.

“We at Finesse are very pleased to have this opportunity to work with Alan and his team of industryprofessionals at Biomedical Resources. Their commitment to the Life Science industry, appreciationof the industry’s history and understanding of its forward direction is without equal,” said LarryWest, Executive V.P. Sales and Marketing Finesse.

About Finesse
California based Finesse is a global leader in process measurement and control technologies. Ourfamily of products – TruBio™, TruLogic™, TruViu™, TruCell™, TrupH™, and TruDO™, provide comprehensivesolutions for measurement and control processes in the biotech and pharmaceutical industries.

About Biomedical Resources
Biomedical Resources specializes in the Cell Culture and Fermentation marketplace where we offerthe most innovative and cutting edge technology in the BioPharmaceutical industry. In addition toour great assortment of products, Biomedical Resources maintains a staff of highly qualified andtechnical personnel as well as our own Service Department, where we will help provide the mostresponsive and outstanding support available.
Media: Kimberly Lozada, 408-327-6613

Finesse Introduces TruViu™ RDPD System

December 14th, 2007 – Finesse Solutions, LLC, Santa Clara, CA, a manufacturer of measurementand control solutions for life sciences process applications, announced the general release of itsTruViu™ RDPD system for biotech R&D and Process Development (PD) applications. The system consists of an I/O tower and a pump tower, with an optional junction box and TruFlow™ gas manifold,namely, all the components required to control a typical R&D or PD bioreactor.

TruViu™ RDPD is designed to be flexible and modular with plug-and-play configuration, in order to maximize ease-of-use, simplify installation, and provide scheduled maintenance. The modular desig nallows TruViu™ RDPD components to be installed on, under, or above the laboratory bench, thereby permitting a significant footprint reduction and greater lab space efficiency.

TruViu™ RDPD brings the benefits of DeltaV reliability and scalability in an affordable package, and interfaces easily with the TruLogic™ Controller and TruBio™ software to deliver optimal bioreactor control.

TruViu™ RDPD also delivers the competitive advantages of increased performance, efficiency and reliability, reduced operating costs and improved ease of use. Finally, TruViu™ RDPD utilizes state of the art transmitters that enable sensor calibration algorithms and full sensor diagnostics.

“Customer response to TruViu™ RDPD has been overwhelming. They love the idea of a standard, configurable product, and now that our reliable hardware has been repackaged into an efficient footprint our biggest issue is keeping up with demand.” Said Alfy Riddle, VP Hardware.

About Finesse California based Finesse leads the way in developing new measurement and control technologies,in order to enable the transition to single-use systems, bring new capabilities to existing bioreactor platforms, and harmonize global bio-process information transfer. Our current product family provides comprehensive measurement and control solutions for upstream processes in the biotech and pharmaceutical industries.

OPC Connectivity with Nova BioProfile 400

March 7, 2008 – Finesse Solutions, LLC, Santa Clara, CA, a manufacturer of measurement and controlsolutions for life sciences process applications, and Nova Biomedical, Waltham, MA, a world leader inbiotechnology process monitoring announced the first TruBio™ OS plug-in for OPC connectivity betweenTruBio™ OS and Nova BioProfile 400, 100 Plus, Basic 4 and Basic 2 analyzers. Both companies confirmedthat a TruBio™ OS plug-in for OPC connectivity to the Nova Flex is currently in development.OPC (Openness, Productivity and Collaboration) has become the de facto standard for data exchangein process control systems. It has been adopted by the majority of the control system manufacturers inthe bioprocess industry and has proven to be a reliable method for sharing information across differenthardware platforms.

Automatic data exchange using OPC between a lab analyzer and control system reduces errors andtime delays of manual sampling, and provides automated reporting of results. It also allows the controlsystem to adjust process parameters without a 24/7 operator presence, and, in the event of processalarm conditions, alerts off-site personnel and/or takes automatic corrective action.This level of integration enables direct consolidation of off-line lab analyzer results into existing historicaldata collection, automates batch report generation, and creates a complete electronic record. Printouts ofstandalone analyzer results do not have to be manually attached or tracked with electronic batch reportsthat control systems already provide.

“Taking advantage of OPC connectivity between Nova analyzers and the Finesse bioprocess controlsystem will improve quality and yield, while reducing operating costs. For example, programming a Novaanalyzer to automatically standardize an in-situ probe, or using the resulting sample data in real-timecontrol algorithms, will increase both process understanding and control accuracy,” stated Dr. MarkSelker, CTO and co-founder of Finesse.

“By redefining the standard associated with offline data to include complete integration and the value ofthose data as they are applied to the bioprocess automatically, Nova and Finesse continue to provide thecutting edge technology required to bring the biotechnology industry into a new era of effectiveness andprofitability. The value lies in the actions upon that information. Nova and Finesse provide the complimentto each other’s technologies thereby allowing our customers real-time benefits that, until now, wereimpossible.” says Bob Fox, Director of Sales.

About Finesse Solutions, LLCCalifornia-based Finesse Solutions, LLC, leads the way in developing new measurement and controltechnologies, in order to enable the transition to single-use systems, bring new capabilities to existingbioreactor platforms, and harmonize global bio-process information transfer. Our current product familyprovides comprehensive measurement and control solutions for upstream processes in the biotechand pharmaceutical industries. For more information, please visit us at www.finesse.com.

About Nova BiomedicalNova Biomedical is committed to continue its technology leadership with advanced products that providebetter, faster diagnostic information. We continue to innovate biotechnology instruments that allow faster,more economical development of drugs and other therapeutic products.

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