integra biosciences: labtools for microbiology · 2016. 1. 17. · labtools for microbiology and...

82 L IFE SC IENCES BUYERS GUIDE 2008 www.pharmaquality.com

INTEGRA Biosciences:Labtools for Microbiologyand Cell CultivationINTEGRA Biosciences AG isa manufacturer of laboratoryequipment for liquid han-dling, sterilization and culti-vation applications inMicrobiology and Cell Biol-ogy. The products are widelyapplied in the pharmaceuti-cal, food and beverage,chemical and medical diag-nostic industry by profes-

sionals in both research and quality control laboratories.Founded in 1965, INTEGRA Biosciences maintains a

worldwide sales and customer support network with over 90independent distribution and OEM partners, which are supportedby a highly motivated and experienced sales and product specialist team headquartered in Chur, Switzerland.

Over the years INTEGRA Biosciences products haveachieved an outstanding reputation for their quality and reliability, many of them have become well-known benchmarkproducts, such as the liquid handling tools: PIPETBOY, VAC-USAFE and DOSE IT; the media preparation equipment MEDIACLAVE and MEDIAJET or the safety Bunsen burnersFIREBOY and FLAMEBOY. In order to continuously translatenew customer needs into reliable, safe and easy-to-use labora-tory tools the company employs marketing specialists, application scientists and design engineers.

INTEGRA Biosciences is an ISO 9001:2000 certifiedcompany.

INTEGRA BiosciencesSchobuhlstrasse 8

CH-7000 Chur, SwitzerlandWebsite: www.dose-it.info

LECO Corporation Delivering the Right ResultsSince 1936, industries around the world have trusted LECOCorporation to deliver technologically advanced products andsolutions for organic and inorganic analysis. Today LECO isrecognized globally as a leader in the development of high-quality analytical instrumentation, next generation mass spec-trometers and chromatography, metallography equipment,and consumables.

TruSpec® Micro CHNS A combination of fast analysis times and reliable automationresulting in high sample throughput make the TruSpec MicroCHN and CHNS ideal for performing pharmaceutical researchand other analyses requiring micro sample sizes. SimultaneousCHN and CHNS analyses can be performed on sample sizesweighing between 1 and 10 mg in approximately four minuteswithout using chromatographic techniques. The instrument’sefficiency and speed are a result of the unique combination ofa flow-through carrier gas system used in conjunction withindividual, highly selective infrared (IR) and thermal conduc-tivity detection systems. The TruSpec Micro’s easy-to-use

Windows®-based software supports compliance to 21 CFRPart 11 regulations mandated by the FDA. Installation Qualifi-cation (IQ) and Operational Qualification (OQ) packages arealso available for the TruSpec Micro CHN, CHNS, and microoxygen add-on module.

Unique® HT LCMSThe Unique’s speed and performance make it one of the mostexceptional MS systems available for complex liquid sampleanalysis. By combining ChromaTOF® software and automatedprocessing tools with fully-integrated control of HPLC and time-of-flight hardware, LECO gives you a cost-effective instrumentideal for metabolomics and environmental applications. Rapidacquisition rates provide the data density required to supportany of the latest fast separation techniques while low detectionlimits, accurate mass measurement, and unique data processingalgorithms simplify even the most demanding applications.Speed and performance packaged in an affordable compactdesign make the Unique a perfect fit for any laboratory.

Whatever your need may be, LECO is there to help you.

LECO3000 Lakeview Avenue

St. Joseph, MI USA 49085Phone: 800-292-6141

Fax: 269-982-8977 Website: www.leco.comE-mail: [email protected]

www.contamination-control.com LIFE SC IENCES BUYERS GUIDE 2008 65www.contamination-control.com LIFE SC IENCES BUYERS GUIDE 2008 83

Lonza presents the PyroSense® on-line monitoring system forthe automatic detection of endotoxin in water systems

The PyroSense® system provides automatic, quantitativedetermination of endotoxin in water at user selected intervals,using a standard assay system with our patented endotoxin-specific PyroGene® recombinant Factor C assay. The systemis designed to test around the clock,seven days a week according to userdemand. The system is designed tooperate in production environments withminimal supervision. All the reagentsand accessories are provided in a dis-posable cartridge that can be quicklyand easily changed by non-technicalpersonnel or by production or qualitycontrol (QC) staff.

Water testing represents approxi-mately 50% or more of the currentaverage volume of testing in the QC lab-oratory. The PyroSense® system offers acost-effective solution for early identifi-cation of potential contamination inyour water system, reducing overalltesting costs and reducing risk.

Developed to meet the growing needfor better control of water quality forproduction purposes, the PyroSense®

system facilitates as well the movetowards direct on-line monitoring of rawor in-process materials, in line with theFDA and EMEA Process Analytical Tech-nology (PAT) Initiatives.

The PyroSense® system is the latestinnovation from the leader in endotoxin detection productsand services.

Lonza introduces the microCompassTM System - a break-through in microbiology technology

Lonza announces the introduction of the microCompassTM

System, a patented breakthrough technology in microbiologytesting.

Lonza will be the first bioscience company to provide amolecular testing method to attain a viable count of microor-

ganisms in as little as four hours. The microCompass™

system dramatically increases the speed for microbiologytesting, as compared to standard methods which require3-14 days.

This unique technology provides genetics based resultsfor enhanced accuracy. Specifically targeting RNA, micro-

Compass™ offers improved sensitivityand detection of viable organisms with-out pre-enrichment. The system allowsquantitative detection of bacteria, yeastand mold at a high throughput-levelby batching up to 96 samples at a time.

Quick time to results (TTR) withmicroCompass™ enables significantlabor and cost savings, as well asdelivers more rapid product release tothe market. These benefits allow foran appreciable increase in clientprofitability.

The microCompass™ system isideal for applications in personal careproducts, pharmaceutical raw materials,bioburden monitoring, preservative effi-cacy testing and cell culture. Applica-tion laboratories for microCompass™ arelocated in Walkersville, MD (USA) andin Saint Beauzire, France.

MicroCompass™ offers accuratetesting in far less time than traditionalsystems.

Lonza is one of the world’s leadingsuppliers to the pharmaceutical, health-care and life science industries. Lonza

is a leader in cell-based research, endotoxin detection andcell therapy manufacturing. Lonza is also a leading providerof value chemical and biotech ingredients to the nutrition,hygiene, preservation, agro and personal care markets. Lonzais headquartered in Basel, Switzerland and is listed on theSWX Swiss Exchange.

For more information on Lonza endotoxin detection prod-ucts, PyroSense® and microCompass™ visit www.lonza.comand click on Endotoxin and Microbial Detection.

Lonza8830 Biggs Ford Rd.

Walkersville, MD 21793


Metrics Inc., headquartered in Greenville, N.C., is one of thefastest-growing contract pharmaceutical development laborato-ries in the United States. The company provides quality pharmaceutical formulation, clinical trial material and smallscale manufacturing (Phase III to commercial), and analyticaldevelopment/validation services to the pharmaceutical industry.

This year, Metrics is completing an $18-million, 47,000-square-foot facility addition that will nearly double its analyti-cal and manufacturing space, dramatically expanding itsservice capabilities to clients.

As part of Metrics’ long-term growth strategy, the expansionalso allows Metrics to increase staff. The company plans toadd at least 50 pharmaceutical scientists and technicians,among them industry veterans with experience to oversee projects from conception through completion.

The expansion is taking place at Metrics’ existing 50,000-square-foot cGMP and GLP facility that is registered with andinspected by the FDA. The added space includes four newanalytical laboratories, larger scale manufacturing (Phase III tocommercial), stability storage, a dedicated laboratory for cyto-toxic and potent compounds, and a microbiology laboratory. Theexpansion increases Metrics’ capacity for service by 40 percent.

Not only will Metrics be able to increase production to 1billion tablets a year (up from the current level of 50 million),but the company’s capacity for stability studies will increaseby 50 percent.

Space for microbiology services will increase five-fold withthe opening of the new microbiology laboratory. Metrics will beable to perform sterility and BET testing as well as bringingantimicrobial assay online. This will enhance Metrics’ particulatematter services, allowing the company to offer full analyticalsupport of parenterals.

Three critical differences set Metrics apart from othercontract laboratories. One, all clients work directly with aMetrics pharmaceutical or analytical development chemist.Two, projects are expedited quickly and efficiently; they don’tlanguish in an analytical development queue. Three, Metrics’quality assurance team is highly experienced, ensuringcompliance with all regulatory issues.

Technical services:• Formulations development• Clinical trial batch and small scale manufacturing (Phase III to commercial)

• Analytical method development and validation with particular expertise in stability-indicating HPLC methods

• Stability storage and testing• Raw material release• Trace element testing• Routine analysis of dosage forms and drug substances

Formulation services:• Tableting• Capsule filling• Over-encapsulation• Milling• Micronizing• Enteric coating• Sustained release and matrix release• Ointments• Creams• Liquids

Metrics Inc.1240 Sugg Parkway

Greenville, NC 27834Phone: 1-252-752-3800

Fax: 1-252-758-8522E-mail: [email protected]


Multisorb Technologies provides leadership, innovation,and solutions utilizing active packaging components to manage moisture, oxygen and/or hydrocarbons in healthcareproduct packaging to improve product stability.

As a single-source provider of a broad range of sorbentmaterials, devices, and related automated insertion equip-ment, Multisorb supports its sorbent products utilizing SimulSorb and SimulOx pseudo-empirical modeling programsto help predict physical and chemical stability outcomes forhealthcare products in their packaging.

From calculations through operations, Multisorb is therefor you with a seasoned team of packaging professionals,chemists, biochemists, and engineers, providing skilledresources to understand and solve virtually any product stability issues.

Multisorb Technologies325 Harlem Rd.

Buffalo, NY 14224 Phone: 1-716-824-8900

Website: www.multisorb.com

The introduction of a one-piece polypropylene shovel more than 30 years ago establishedRemco Products as an industry pioneer. Today, Remco maintains its presence as a trustedsupplier to the food processing, pharmaceutical, jansan, safety, and material handlingindustries. It provides a large selection of color-coded quality plastic products to thesedistinct markets.

With today’s increasing focus on hygiene and cross-contamination issues, Remco hastaken the approach of proactive product development to help companies comply withstringent HACCP regulations and guidelines. The color-coded tools from Remco are madefrom FDA-approved materials and ISO-certified, providing the ultimate step in qualityassurance and safety for the various industries.

Remco not only supplies the highest in quality; it maintains personal integrity and con-tinues to increase customer loyalty by expanding inventories and maintaining a well-earnedreputation for excellent customer service. Recognized as a world leader, Remco remainsdedicated to providing innovative products through its extensive network of distributors.

Remco’s wide selection of products includes polypropylene shovels, scoops, scrapers,kart tubs, and mixing paddles in addition to a line of color-coded metal detectable prod-ucts. Remco also offers the Vikan hygiene system® of brooms, brushes, squeegees, pails,and handles.

Remco Products4735 W. 106th Street

Zionsville, IN 46077Phone: 1-317-876-9856

Fax: 1-800-585-8619 Website: www.remcoproducts.com


ROQUETTE PHARMA – MAKING LIFE BETTERROQUETTE is a leading global partner of the pharmaceuticalindustry, actively developing various carbohydrate-based functional pharmaceutical excipients and actives to enableoutstanding formulations.

The US FDA and European authorities regularly audit ourmanufacturing facilities guaranteeing consistent complianceand reliability of ROQUETTE’s services and products to thehighest international quality requirements.

THE POLYOL WORLD LEADER ROQUETTE offers the broadest polyol excipient range provid-ing excellent chemical stability with good taste, sugar-freesweetness and oral health benefits for numerous pharmaceu-tical applications.

This includes:PEARLITOL® crystalline mannitol and granulated mannitol,NEOSORB® sorbitol, MALTISORB® maltitol, XYLISORB® xylitol and LYCASIN® maltitol syrups

FUNCTIONAL EXCIPIENTS FOR FORMULATION CHALLENGES A dedicated manufacturing, research and quality network in

Europe, Asia, and USA enables ROQUETTE to develop func-tional excipients such as DILUENT-BINDERS, GRANULATIONBINDERS, DISINTEGRANTS and FILM COATING POLYMERS.Our in-house team of scientists can help in formulation development for our customers, notably in the areas of:

• Tablets obtained by direct compression or wet granulation • OTC and nutraceuticals as fiber sources and mineral supplements

• Syrups, suspensions, Granules and sachets • Tablet Film coating and Thin-film delivery systems• Toothpastes and mouthwashes • Injectables (enteral and parenteral solutions)

LEADING ROLE IN INJECTABLES AND DIALYSIS SOLUTIONSROQUETTE is the specialist of excipients for injectables anddialysis solutions. Produced for over 20 years, pyrogen freedextrose monohydrate LYCADEX® PF is used by majority ofpharmaceutical companies involved in the production ofinjectable solutions and infusions.

The established range also includes pyrogen free polyols(PEARLITOL® PF mannitol, NEOSORB® PF sorbitol, andXYLISORB®PF xylitol) as well as KLEPTOSE®HPB, pyrogen freehydroxypropyl beta-cyclodextrin. Most recently ROQUETTE alsointroduced pharma grade LACTATE and GLUCONATE salts.

FOCUS ON INNOVATION The demand for novel functional excipients and health supple-ments continues to grow steadily. Thanks to our longstandingtrack record in excipients and actives innovation, ROQUETTEis ready to meet this challenge:

NUTRIOSE® soluble fibers for nutraceutical formulationsand clinical enteral nutrition NUTRALYS® - a new natural, nonGMO, allergen free pea protein LYCOAT® Novel starch-based polymers developed for fast and simple aqueous film coating. LYCATAB® Mineral - for mineral supplementation fornutraceutical and OTC applications PEARLITOL® mannitol as outstanding diluent-binder forsolid dosage forms KLEPTOSE® cyclodextrins for molecular encapsulation/solubilization

Let us share our expertise with you to create outstanding newformulations!

Contact us: Learn more about Roquette’s extensive range ofexcipients and actives, as well as services through our dedicatedpharma website: www.roquettepharma.com. You can also contact us directly at: [email protected]

Roquette America, Inc1417 Exchange Street

Keokuk IA 52632Phone: 1-319-524-5757

Website: www.roquettepharma.comEmail: [email protected]


SGS Life Science Services is a leading contract service organi-zation providing clinical research services and quality controltesting. We serve a variety of Life Science companies includingpharmaceutical, biopharmaceutical, biotechnology andmedical device manufacturers. SGS provides clinical trialmanagement (Phase I to IV) and services encompassing bio-analytical services, data management, biostatistics andregulatory consultancy. We also offer quality control services(detailed below) that include analytical chemistry, microbiol-ogy, stability studies, method development, toxicology, andprotein analysis. SGS is the world’s leading verification testing,inspection, and certification company.

Technical Services• Quality control testing of raw materials, APIs and finishedproducts

• Monograph testing (USP, EP, BP, JP)• Analytical method development and validation• Cell line characterization• Container testing • Environmental testing• Host cell impurity testing

• Inspection services• Medical device testing• Microbiological testing • Mycoplasma testing• Protein Analysis• Safety testing (in vivo, in vitro) • Stability testing according to ICH guidelines or customerspecifications

• Water system validation

Markets ServedSGS operates a global network of quality control testing laboratories with facilities in the USA, Canada, Belgium,France, Germany, India, Hong Kong, China, Taiwan, Thailandand Singapore.

FacilitiesIn North America, SGS has facilities in Northbrook, IL, Fairfield,NJ, and Mississauga, ON. Our quality control laboratoriesoperate according to the highest quality standards (cGMP, GLP,ISO 17025) and have been inspected by the FDA and/or localregulatory authorities.

SGS Life Science Services75 Passaic AvenueFairfield NJ 07004

Phone: 1-866-747-5003Fax: 1-973-244-1823

E-mail: [email protected]


Shimadzu Scientific Instruments, the American subsidiary ofShimadzu Corporation, headquartered in Kyoto, Japan, offersa full line of analytical measurement and testing instrumenta-tion for a broad range of applications in science and industry,including Pharmaceuticals.

Products include chromatographs (HPLC/UFLC, GC); massspectrometers (GC/MS, LC/MS, MALDI); spectrophotometers(FT-IR, Fluorescence, UV-VIS-NIR); atomic spectrometers (AA,ICP); X-ray spectrometers (EDX, XRD, XRF); thermal analyzers;Total Organic Carbon (TOC) analyzers; data systems/software;particle size analyzers; balances (semi-micro, electronic, analytical, top-loading, portable, moisture); and various mate-rials testers (universal/tensile, hardness, capillary/flow,endurance/fatigue).

Recent key developments include:• Prominence UFLC (ultra fast liquid chromatograph): Delivers powerful high-speed analysis – without sacrific-ing performance, reliability, or ruggedness; for uniquechallenges that demand the use of longer columns forextra resolution, users can convert their current Promi-nence UFLC to a UFLCXR system or can purchase anew UFLCXR system, which is capable of system pres-sures up to 9500 psi (66MPa)

• MCE-202 MultiNA automated electrophoresis system:With reusable microchips, and completely automatic,the MCE-202 is a faster and more sensitive alternative toagarose gel electrophoresis for DNA and RNA nucleicacid size confirmation and quantitation

• Prominence nano HPLC: Supports high-precision gradientanalysis by providing advanced flow-rate precision in thenano flow-rate range

• UV-1800 Spectrophotometer: Boasting the highest resolu-tion (1 nm) and smallest footprint in its class, the UV-1800 delivers powerful performance and functionality ina compact design

• IRAffinity-1 FTIR spectrophotometer: Uses high-throughputoptical elements and a dynamic alignment mechanism toincrease sensitivity, stability and usability, making it idealfor high-precision infrared analysis to confirm, identifyand detect foreign matter in raw materials, medicalproducts, packages and coatings

• TX/TXB series of top-loading electronic balances: Meetingthe recent demand for intermediate-range balances withcompetitive performance and price, this new lineupincludes TX electromagnetic force restoration balancesequipped with the UniBloc aluminum integral mass sensorand TXB electronic balances with a load-cell function

• AXIMA MALDI TOF Series: Powerful mass spectrometers,the new series – Performance, Confidence, Assurance –provides users with the ultimate in performance and flexibility. From routine analysis of a wide variety of sam-ples to robust and reliable research-grade performance,the AXIMA Series delivers excellence without compromise

By partnering with customers and listening to their input, Shimadzu’s people continue to develop and manufactureinstruments that deliver results faster and more efficientlythan ever before to meet the needs of researchers, scientists,and manufacturers around the globe

Shimadzu Scientific Instruments7102 Riverwood DriveColumbia, MD 21046

Phone: 1-410-381-1227/1-800-477-1227Fax: 1-410-381-1222

Website: www.ssi.shimadzu.comE-mail: [email protected]


Founded in 1994, Sparta Systems Inc. is an enterprise software manufacturer that has developed innovative, 21 CFRPart 11 compliant Quality Management System (QMS) soft-ware for logging, tracking, reporting, and trending quality andregulatory issues and actions. TrackWise enables the life sciences industry to increase compliance and reduce risk byefficiently managing and tracking quality and regulatory com-pliance actions, including Deviations, Audits, Inspections,

CAPA, Change Control, Commitment Tracking and ComplaintHandling. With over 150 FDA-regulated customers and over300,000 end users, TrackWise has become the provenstandard for managing and tracking quality and compliancerelated processes.

TrackWise provides a 100% configurable solution out ofthe box and requires no custom code. Organizations canquickly implement TrackWise without lengthy implementationprocesses and related costs. TrackWise provides maximumflexibility, and includes the ability to define web-based data-entry forms, user-defined fields, workflows, security permis-sions, reports, automated trending rules and other necessarybusiness rules. TrackWise also provides real-time integrationto leading ERP systems such as mySAP and JD Edwards One

World, providing an excellent fit into the existing enterprisearchitectures.

Sparta Systems’ TrackWise is an agile, user-friendly andflexible solution designed to meet industry demands. Its archi-tecture enables organizations to initially deploy any applica-tion, and subsequently expand the system to other processes,using the same licensed software. TrackWise delivers modular-ity and scalability out-of-the-box, where modules (work areasand applications) can be defined and configured by the customer.

Powerful workflow tools manage the life cycle of all qualityissues and related corrective and preventive actions. Track-Wise’s built-in 24/7 business rule engine provides automatedrouting, notifications, escalations, automated execution anddistribution of management reports, and automated trendingand alerts. Integrated reporting via Crystal Reports® allowsusers to generate an array of customized reports for furtherdetailed analysis.

TrackWise helps pharmaceutical organizations:

• Manage all quality and FDA compliance related processesin a centralized database with a single platform

• Enable site level, process level, and role-based securityStreamline workflow with robust automation

• Escalate past due items and provide visibility to commonproblem areas

• Obtain information instantly using powerful ad hocqueries and personalized dashboards

• Leverage powerful status reports and metrics • Meet 21 CFR Part 11 requirements for electronic signatures, and both record level and configuration levelaudit trails

• Make changes to the system seamlessly using point-and-click configuration tools

Sparta is ready to work with your organization to under-stand its needs and goals. In addition to providing detailedproduct information, our experienced pre-sales solutions teamwill provide your project team with an overview of industryproven solutions and best practices, and assist with imple-mentation and deployment planning.

Sparta Systems, Inc.Holmdel Corporate Plaza

2137 Highway 35Holmdel, NJ 07733

Toll Free: 1-888-261-5948Outside the US: 1-732-203-0400

Fax: 1-732-203-0375Website: www.sparta-systems.comE-mail: [email protected]

[email protected]


Waters Corporation, the premium brand in the analyticalinstruments industry since 1958, creates business advantagesfor laboratory-dependent organizations by delivering practical andsustainable scientific innovation to enable significant advance-ments in such areas as healthcare delivery, environmentalmanagement, food safety, and water quality worldwide. Bringingkeen understanding and deep experience to those responsible forlaboratory infrastructure and performance, Waters helps customersmake profound discoveries, optimize lab operations, deliver productperformance and ensure regulatory compliance. Pioneering aconnected portfolio of separations and analytical science, labora-tory informatics, mass spectrometry as well as thermal analysis,Waters’ technology breakthroughs and laboratory solutions providean enduring platform for customer success.

Our technological expertise is in the following areas:

Markets ServedWaters drives decision-making and improves laboratory effective-ness within the pharmaceutical, life sciences, environmental, foodand beverage, agriculture and diversified chemical industries byproviding the tools to improve the quality of today’s science andexplore the infinite possibilities of tomorrow’s.

Waters provides direct support to scientists in more than 50countries through an international network of laboratories andsupport facilities.

Major Products/ServicesWaters’ main products are instruments, software, chemistries, andsupport services for LC and MS. Our best-known brands are:

Instruments• ACQUITY UPLC® Systems • Alliance® HPLC Systems• Synapt High Definition MS™ Systems• IdentityE High Definition Proteomics™ Systems• Premier™ Mass Spectrometers

Chemistries• ACQUITY UPLC® Columns• XTerra® Columns• XBridge™ Columns• Symmetry® Columns

• Spherisorb® Columns• Atlantis® T3 Columns• SunFire™ columns• Oasis® Sample Extraction Products• Intelligent Speed (IS™) Columns• Optimum Bed Density (OBD™) Preparative Columns• RapiGest™ SF Surfactant• NanoEase™ Capillary, Trapping and Nano-scale Columns for LC–MS• MassPREP™ Reference Standards and MALDI matrices• Sep-Pak® SPE Products• Sirocco™ Protein Precipitation Plates• Certified Vials and Filtration Products

Informatics• Empower™ Chromatography Software (ISO 9000 TickIT-certified

and 21 CFR Part 11 compliant-ready)• MassLynx™ MS Software• NuGenesis® SDMS Software• SDMS Vision Publisher™ Software

Services and Support• Compliance Services• Waters Quality Parts®

• Waters Global Services

To order our chemistries on-line or to check product availability,order status, delivery timetables, and company-specific pricing,please visit www.waters.com. In addition, Waters sells a completeline of standalone detectors, pumps, autosamplers, injectors,fraction collectors, and accessories.

FacilitiesWaters operates cGMP and ISO 9001-2000-certified manufacturingplants in Milford, Massachusetts (instruments, parts); Manchester, UK(mass spectrometers), Taunton, Massachusetts (chemistries); andWexford, Ireland (chemistries/mass spectrometers).

SubsidiariesTA Instruments, Inc., New Castle, Delaware

Recent Awards• Frost and Sullivan Market Leadership and Product Innovation

Awards (2007)• Pittcon® Editors Gold Award for the Synapt High Definition MS

System (2007)• American Red Cross Circle of Humanitarians Award (2006)• Frost & Sullivan Analytical Instrument Company of the Year (2005)• R&D 100 Award for the ACQUITY UPLC System (2005)• Pittcon Editors Gold Award for the ACQUITY UPLC System (2004)• Omega Northface Customer Satisfaction Award (2000 - 2006)

Waters Corporation34 Maple St. Milford, MA 01757

Phone: 508 478 2000Fax: 508 872 1990

Website: www.waters.com

• UltraPerformance LC® (UPLC®)• UPLC–MS• HPLC and LC–MS• Mass Spectrometry• MSE Technology• Gel Permeation Chromatography• Preparative Liquid Chromatography

• Thermal Analysis• GC–MS• Rheology• Microcalorimetry• Mycotoxin Testing• Proficiency Testing


WellSpring Pharmaceutical is a full-service provider of contract clinical and commercial manufacturing and packag-ing solutions for virtually all finished non-sterile solid andsemi-solid dosage form products, including tablets, capsules,creams, lotions, ointments, gels and oral suspensions andsolutions. We provide clinical manufacturing, over-encapsula-tion, labeling, packaging, storage, distribution and returnedgoods management to support our clients’ most complex clinical trial requirements, from a local Phase I study to aninternational Phase IV study.

Centrally located, our capabilities include blending, fluidbed granulation, tablet compression, encapsulation, film coating, and topicals and liquids processing to accommodaterequirements of any size. Extensive packaging capabilities

enable tablets or capsules to be bottled or blister-sealed invirtually any quantity or presentation. Liquids, creams or ointments can be supplied in varying sizes of bottles, jars,tubes and enema formats. WellSpring’s Quality Services teamprovides full analytical, microbiological and quality assuranceexpertise to ensure full regulatory compliance. Our facility andquality systems have been successfully inspected by HealthCanada and the FDA and meet current cGMP requirements.

At WellSpring, we’ve worked hard to build a pharmaceuticalcompany that stands out from the crowd. Our overarchingcommitment to taking care of even the smallest details hasled to several of our biggest achievements, most notably ourability to build productive global partnerships by perfectlycomplementing the operations of a growing roster of clients.

WellSpring Pharmaceutical400 Iroquois Shore Rd.

Oakville, ON L6H 1M5 Canada Phone: 1-905-337-4533

Website: wellspringpharm.ca


Xcelience Expands Its Early Drug Development CapabilitiesXcelience, a leading pharmaceutical contract research organiza-tion, is the premier source for unsurpassed quality in drugdevelopment. We consistently and efficiently move our spon-sors’ Active Pharmaceutical Ingredients (APIs) through the drugformulation process, getting them to clinic and market faster.Xcelience combines the industry’s top-performing formulationdevelopment scientists with state-of-the-art equipment.

Led by dedicated project management, our scientific teamswork as an extension of your organization throughout the drugdevelopment process.

Xcelience’s Core Services

Preformulation:Xcelience’s range of preformulation studies allows us to opti-mize your dosage form at the earliest stage of drug develop-ment. Our scientists have experience in the preformulation tosupport all your product needs.

Formulation:The scientific team creates options for formulation to meetyour dosage range and preferred route of delivery. We are ableto formulate the following dosage forms:

• Solids- Tablet formulation- Hard gelatin capsule formulation- Granules- Powders

• Liquids:- Oral and topical liquids- Suspensions- Emulsions

• Semi-solids:- Creams- Ointments- Gels

Analytical:State-of-the art facilities and instrumentation provide an opti-mal environment for stability studies, including a full range oftemperature and relative-humidity conditions.

Manufacturing: Our scientists are the industry’s most respected in the field offormulation development. Contact us for:

• Manufacturing batches for stability testing• Scaling up and production of pilot batches• Manufacturing of clinical trials supplies from Phase l toPhase IIb, including individual capsule filling of API,tableting, encapsulation, placebo matching, over-encap-sulation or coating of comparators.

• Process validation and technology transfer.

Xcelience has expanded our early drug development capabilitiesby being the first CRO in North America to acquire the Xcelo-dose® 600 S precision powder micro-doser and automatedencapsulator system. The next generation S model fills at speedsof over 600 capsules an hour, and accompanies its predecessorthe Xcelodose 600 in our effort to get sponsors to clinic.

Xcelience has built up a wealth of drug development expe-rience since purchasing its first Xcelodose system in 2005.Sponsors are drawn to the company’s speed in helping getthem to the clinic. The new model is faster and will add toour responsiveness time.Xcelodose® is a registered trademark of Capsugel BVBA.

Facility Overview:Xcelience has grown exponentially since its inception. Inaddition to expanding operations in 2007 with the acquisitionof a new facility, the company boasts an array of new equip-ment, including the Vector TFC Roll Compactor, to furtheramplify its vast capabilities. Our laboratories are fully cGMPcompliant and registered with the FDA and DEA.

We Challenge You to Challenge UsXcelience®

Xcelling the Science of Formulation Development

Xcelience, LLC5415 West Laurel Street

Tampa, FL 33607Phone: 813-286-0404

Fax: 813-286-1105Website: www.xcelience.com

E-mail: [email protected]

integra biosciences: labtools for microbiology · 2016. 1. 17. · labtools for microbiology and...

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