Pharmaceutical Online The Magazine -- Fall Digital Edition 2009

VertMarkets, Inc., publishes industry-specific trade magazines that serve key decision-makers and professionals in a select set of targeted vertical markets. As a complement to VertMarkets' leading online industry Web sites, the magazines offer readers compelling editorial, providing news analysis, market trends, technical reviews, case studies, technical papers, and other educational articles authored by some of the most respected experts in the industries we serve.

Additionally, each magazine has a comprehensive Buyer's Guide section designed to promote the latest innovations and products from the leading companies in the market. VertMarkets' circulation model aligns directly with the needs of our readers, as our magazines are aggressively distributed at and around many key industry tradeshows throughout the year. VertMarkets plans to continue building on the support we give our readers by expanding our magazine publishing business.

Pharmaceutical Online The Magazine, Fall Issue • Launch Date: October 2009 • Tradeshow Distribution: ISPE, AAPS and Pittcon 2010 Current Issue Table Of Contents: • From The Publisher • New Inhaled Liposomal Cyclosporine: A Formulation Gives Hope For Lung Transplant Recipients • Advanced Size Exclusion Chromatography Beneficial To Pharmaceutical Development • Using Terahertz Pulsed Imaging Optimizes Coating Parameters • Instrumentation For Product Control Vs. Process Control • Glass-Lined Side Baffles Boost reactor Flexibility, Efficiency • The State Of The Art In Powder Filling For Pharmaceutical, Biotech, And Nutritional Dry Products • Loss-In Weight Feeding And Continuous Extrusion • Sequence-Based Analysis Enables Manufacturers To Develop And Maintain A Relevant, Validated Library  • An Alternative Approach To Laboratory Fume Hood Design Results In Energy Savings, Safety Standards • Quality Manufacturing Leads To Efficiencies, Profits • Submit editorial to: themagazine@pharmaceuticalonline.com • Contact Rich Ranus for advertising information

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2009 Pharmaceutical Online The Magazine  • Online Buyer's Guide Index  • Online Buyer's Guide 

AUTOMATED ENVIRONMENTAL MONITORING
  Rees Scientific 

COMPONENTS/SINGLE-USE
  Gore PharmBIO Products

DATALOGGERS
  Mesa Laboratories, Inc.

FILLING EQUIPMENT
  CAPSUGEL

GRANULATION AND
PARTICLE SIZING
  Clemex Technologies, Inc.    

INDUSTRY EVENT
   Reed Exhibitions

LABORATORY EQUIPMENT
  Applikon Biotechnology

LIMS Software 
  Thermo Fisher Scientific

LYOPHILIZATION
   Anteco Pharma

MICROBIOLOGY TESTING
  Accugenix

PHARMACEUTICAL DEVELOPMENT
  Advantar Laboratories, Inc./
   NextPharma Technologies

AUTOMATED ENVIRONMENTAL MONITORING

COMPONENTS/SINGLE-USE

Rees Scientific has been providing automated temperature monitoring solutions for over 25 years. Our systems are designed with loss prevention and compliance in mind. Rees Scientific Centron Environmental Monitoring Systems answer the critical equipment monitoring and alarming challenges faced by today's pharmaceutical industry. As an ISO 9001:2000 company, Rees Scientific is constantly upgrading policies, procedures, and protocols to comply with today's highly regulated environments. Rees helps clients meet critical, GxP, FDA, USP797, and other regulatory requirements. Our live, 24/7/365 technical support team ensures needs are responded to promptly and closed out correctly. Our project managers, customer, and technical support teams are experienced and dedicated to our customers. Together, they ensure that your system is well maintained, up-to-date, and working properly. Our goal remains sharply focused to ensure that your critical equipment and devices are monitored and maintained to set a standard every second of every day, without exception and without fail.

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CONTRACT ANALYTICAL/MFG./PACKAGING

CONTRACT MANUFACTURING

SCI provides expert pharmaceutical contract services as follows:
Analytical Testing — Our modern laboratories provide a broad range of quality control, method development, validation, HPLC, GC, GC/MS, dissolution, and product support analytics.
Stability — Our new walk-in rooms and stability chambers provide a complete array of conditions to meet any regulatory specification. Chambers are monitored 24 hours a day, and have generators.
Contract Manufacturing — Fully compliant cGMP manufacturing capability, from thousands to millions of dosages of product, in temperature and humidity controlled suites, using state-of-the-art machines. We manufacture tablets, capsules, and soft gelatin capsules.
Packaging — We package tablets and capsules on high-speed packaging lines, or provide you with small quantities of packaged material for your clinical trials.
Blister Packaging — Our high speed blister packaging line produces commercial or clinical quantities of aluminum/plastic cards to fit your specific need.

Patheon Delivers With New Performance-Based Contracts In 2008, Patheon set out to become the best Contract Development and Manufacturing Organization (CDMO) in the industry. The executive team — led by CEO and president Wesley P. Wheeler — determined a new course for the company.Now, in 2009, Patheon has achieved significant progress, exemplified by the company's most recent KPIs: Batches Right First Time average through July is 92% throughout all sites, and the On Time Delivery average through July is 94% network-wide. These numbers are unmatched in the industry.For Patheon's customers this equals security of supply and unparalleled quality for their products. Patheon is so confident that it's now offering the Patheon Performance Guarantee, backed up by new performance-based contracts. The company is also offering current contract reviews and special tech transfer pricing. For more information, contact a Patheon representative or email Patheon at doingbusiness@patheon.com.

CONTRACT MANUFACTURING AND TESTING

CONTRACT MANUFACTURING AND TESTING

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CONTRACT MANUFACTURING AND TESTING

DATABASES

SCYNEXIS, Inc. is a premier drug discovery and development company delivering effective and innovative drug pipeline solutions to human and animal health pharmaceutical and global health partners. Our drug discovery and development services take your compounds from concept to clinic with speed and innovation. Our contract research and manufacturing services are available on a fee-for-service basis or may be conducted in a shared-risk arrangement. SCYNEXIS is headquartered in Research Triangle Park, NC, and occupies more than 120,000 sq. ft. of laboratory and office space strategically located in close proximity to RDU International Airport, UNC-Chapel Hill, Duke University, and North Carolina State University. SCYNEXIS is registered with the FDA and DEA. Our expertise areas include:
• Medicinal Chemistry and Drug Discovery
• ADMET-PK and Bioanalytical Testing
• Process Chemistry and Chemical Development
• Process Scale-Up
• cGMP API supply
For more information, visit us on the Web at www.scynexis.com.

Organic Materials AnalysisPDF-4/Organics 2010 is designed for rapid materials analysis of organics and organometallic materials and their common formulations. While PDF-4/Organics contains predominantly organic and organometallic materials, it also contains thousands of reference data for polymeric and inorganic excipients, common inorganic salts, and starting materials. We have added all the types of materials typically found as reaction products and formulation ingredients.
Applications
• Material Identification
• Quantitative Analysis
• Formulation Analysis
• Polymorph Identificationu Salt, Solvate, and Hydration Analysis
• Crystallite Size Analysis
PDF-4/Organics Content
• ~400,000 material data sets, edited and standardized for rapid identification
• 20 subfiles, including excipients, pharmaceuticals, and forensics
• I/Ic values for quantitative analysis
• Digital pattern simulations for crystallite size and total pattern analysis
• An extensive compilation of known polymorphs, hydrates, and solvates for commercial drugs

Visit ICDD's website for publications related to the technology and applications of the Powder Diffraction File.

http://www.icdd.com/support/references/default.htm

DATALOGGERS

FILLING EQUIPMENT

Mesa Laboratories, Inc. offers high-quality data loggers for monitoring temperature, humidity, and pressure and specialty biological indicators (BIs) for medical device and pharmaceutical manufacturing. DataTrace and Raven products are available to accurately monitor and validate EO and/or steam sterilization, autoclave validation, incubators, heat tunnels, and more.
DataTrace is a line of NIST traceable, high-quality data loggers that are the ideal wireless solution for the validation and monitoring of temperature, humidity, and/or pressure within a process or vessel. With a potential temperature range of -80°C to +400°C, the DataTrace Micropack Radio Frequency (MPRF) temperature logger provides real-time data in a compact, wireless unit.
Raven biological indicators are used to assess the effectiveness of sterilization processes including steam, EO, H2O2, dry heat, and a host of medical device and pharmaceutical manufacturing applications. Services such as organism identification, population verification, sterilization process development, and custom biological indicator production are also available.

Xcelodose® S Precision Powder Micro-Dosing SystemWith the Xcelodose® system, creating manufacturing batches for clinical trials and small-scale production has never been easier or more precise. That's because this unique technology allows companies to fill capsules with drug substances alone, thereby eliminating the need for excipient compatibility and preformulation activities.Xcelodose® Benefits
• Even ‘Faster Time to First in Man' with precision, speed, and accuracy
• Fills with precision at speeds of over 600 capsules/hour at ~2% RSD — approximately 10x faster than filling by hand
• Allows filling of API direct into capsules, with no need for excipients, and can thereby save up to 6 months of development time by reducing the need for formulation development and stability testing
• Accurate drug records for the monitoring of batches and individual capsules — the weight of each capsule and event is recorded
• Doses as low as 100 micrograms for precise drug trials
• Capsule size change can be achieved in minutes — change parts sizes 00 to 4 available u Wide range of optional extras and accessories available.

GRANULATION AND PARTICLE SIZING

INDUSTRY EVENT

INTERPHEX is where the industry comes together to:
SOURCE. Meet face-to-face with leading industry suppliers and service providers showcasing the latest innovations, equipment, and solutions that are helping advance our industry.
ENHANCE KNOWLEDGE. Participate in an educational program with sessions designed to sharpen the skills you and your company need to excel in an ever-changing industry.
EXCHANGE IDEAS. Share insights, ideas, and best practices with leaders from across our industry. 

LABORATORY EQUIPMENT

LIMS SOFTWARE

This year, at the 25th annual FEW in Denver, CO, Applikon introduced the Alcohol Fermentation Monitor — a small-scale fermentor system with six 500 ml vessels that accurately measures feedstock conversion rates in real time. The data collected allows operators to make critical comparisons between feedstock variations, host strain variations, and monitor other process condition changes at a small and manageable scale.This product also offers benefits for the brewery and distillery industries. Testing yeast fermentation performance is extremely useful for testing the real degree of fermentability of worts produced according to different recipes.

LYOPHILIZATION

MICROBIOLOGY TESTING

Anteco Pharma specializes in GMP compliant formulation, lyophilization, and packaging for the pharmaceutical, medical device, and nutritional ingredient industries. Our focus is innovation, flexibility, and quick response. Our strengths are a validated, state-of-the-art facility, an experienced staff with a track record of success, and a fully compliant quality system. We are now ISO 9001 and ISO 13485 certified and registered with the US FDA as both a drug and a medical device manufacturer.

Our services include:
• Lyophilization capacity from 1 to 2,000 liters
• ISO 7 manufacturing suites
• Formulation
• Packaging
• Process development, scale-up, and transfer
• Project management and compliance support

Anteco Pharma's quality system is compliant with international drug, medical device, food, and dietary supplement GMPs. Customer, third party, and regulatory audits are encouraged and supported.
Let us show you how we can use these resources to provide cost-effective solutions to your most challenging manufacturing problems.

Accugenix, Inc. provides leading-edge technology in microbial identification and characterization services. Our FDA-registered lab is cGMP compliant and maintains rigorous standards competitive at the global level. We specialize in testing, analyzing, and interpreting data from environmental isolates commonly found in pharmaceutical, biotechnology, medical device, neutraceutical, personal care, and other manufacturing industries. For more than 20 years, Accugenix has provided the fastest, most accurate and reliable microbial identification services to over 400 facilities around the world. Accugenix updates its validated, proprietary DNA sequence libraries annually to reflect current taxonomy and newly described relevant species. We have the industry's first fungal library based on the ITS region. Since inception, we have tested more than 300,000 microorganisms — more than any other service laboratory in the industry — while maintaining an on-time delivery of over 99%. Visit www.accugenix.com or call (800) 886-9654 or +49 (0) 621-3709-556. Accugenix — the leader in genetic microbial identification.

PHARMACEUTICAL DEVELOPMENT

PHARMACEUTICAL PACKAGING AND LIQUID

Scientific knowledge, unparalleled experience, and best-in-class service — reap these benefits and more when you take advantage of the new partnership between Advantar Laboratories and NextPharma. Working together, our firms can provide the full spectrum of contract laboratory and manufacturing services for your small to mid-size company. From sterile contract manufacturing, clinical trials, packaging, cold chain storage, and distribution, to high-quality analytical development and testing, our team of experienced scientists has the knowledge and capability to drive your project forward and ensure deadlines are met. Work smarter, not harder. Call Advantar Laboratories to see how we can help you streamline your development program and save you time and money today!

What does your packaging say about your product?
McKesson RxPak understands how hard you've worked to build your brand's reputation with consumers. And we know how important it is to continue strengthening this reputation. You can trust us to ensure that your image reflects your commitment to high standards.
A leading provider of packaging products and services, McKesson RxPak provides today's top pharmaceutical companies with:
• Proven expertise in compliance and consumer-friendly packaging for children and seniors
• A wide array of contract services: compliance, blister, bottling, secondary packaging, and more
• Commitment to the highest security standards

A Compliance Packaging Leader
McKesson RxPak has joined forces with Burgopak Ltd., the UK's foremost packaging innovator, to bring Burgopak's award-winning pharmaceutical compliance packaging to the United States. Burgopak's patented, simple-to-handle packaging design can help improve medication adherence and product safety, and is available in a sliding tray or blister pack.

For more information, please visit www.rxpak.com.

POWDER PROCESSING

TABLET EQUIPMENT AND ACCESSORIES

Harro Hofliger is a dynamic organization, widely recognized as a high-end supplier of production and packaging equipment, primarily to the pharmaceutical and medical device industries. In addition to our standard products, we provide innovative, custom solutions to meet the needs of our valued customers. We have delivered equipment to assemble and package an array of applications such as:

• Capsule filling
• Transdermal patches
• Capsule and tablet weighing
• Wound dressings
• Powder handling and dosing
• Dissolvable oral film strips
• Liquid and powder inhalers
• Diagnostic test strips
• Wallet packs for blisters
• Pouching
• Side and top-load cartoning
• Aseptic assembly
• And many other products with nonstandard requirements 

At Hofliger, quality begins with the first design concepts and continues through to the finished product. We bring specialized technical knowledge, machine building expertise, and full-service customer support to every project. 

Harro Hofliger Packaging Systems
1 Edwards Court, #101
Burlingame, CA 94010
350 S. Main Street, Suite 315
Doylestown, PA 18901
Contact: John Van Tol
PH: (215) 345-4256
jvantol@hofliger.com
www.hofliger.com

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