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Brochure: Thermo Scientific HyClone® Rapid Response Production™ Thermo Scientific HyClone Rapid Response Production (RRP) Service can facilitate your research, product and process development. 03/15/2010 387.0 KB
White Paper: For Potent Product, Reliable Resource Is Required Probiotics, products that contain scientifically documented live microorganisms, are increasingly being used by consumers around the world. Market growth could potentially be significant, offering sizable opportunities to scientific-minded companies aware of the complexities of probiotics. By Ropack, Inc 03/11/2010 148.0 KB
Datasheet: SART System™ The SART System™ is designed to allow aseptic liquid transfer between two areas with different containment classifications. The SART System™ consists of an external port, an internal port and a disposable connection device – Gammasart ATD™. 03/10/2010 59.1 KB
Datasheet: Opta® SFT The Opta® SFT Sterile Connector is a single-use device, composed of pre-sterilized female and male coupling body, that allows a sterile connection in biopharmaceutical manufacturing processes. 03/10/2010 71.8 KB
Brochure: BIOSTAT® CultiBag RM The BIOSTAT® CultiBag RM is the new generation of disposable bioreactors utilizing rocking motion for mixing with low shear. The combination of a new generation of Sartorius Stedim Biotech engineered control capabilities launches the disposable bioreactor system into a new era of cultivation. 03/10/2010 215.3 KB
White Paper: Computer System Validation And FDA Inspections Often, the FDA comes to inspect your facility for reasons other than your computer system validation (CSV) program. However, because so many of our business processes are governed by electronic systems, the topic of CSV inevitably comes up during the course of an inspection. By Michael Gregor 03/08/2010 69.8 KB
Article: A Focus On The Science And The Business RXi Pharmaceuticals was founded by one of the codiscoverers of the RNAi mechanism and recent Nobel laureate Craig Mello, Ph.D., professor of molecular medicine at University of Massachusetts. Dr. Mello is still a member of the company’s scientific advisory board. By James Netterwald, Ph.D. 03/08/2010 89.3 KB
White Paper: Can Your Cold Chain Hurt Your Company’s Brand? Consider how important it is for the physicians administering your drugs to have a good perception about your company. And by good perception, I don’t mean that they just are satisfied with the drugs you produce, I mean they like the drugs and your company in general; they feel confident that you’re top-notch. Sure, there is a lot of marketing that goes into creating that perception, but what you may not realize is that your cold chain processes and technologies can have just as big an impact on a customer’s perception as any advertising or marketing campaign. By Dan Schell, Life Science Leader magazine. 03/08/2010 70.5 KB
White Paper: Fiscally Fit Facilities: A New Look At What It Means To Be Lean Optimizing the fitness of a manufacturing facility requires a multifaceted approach, using a combination of lowering operating expenses, increasing throughput, and reducing inventory. By Cindy Lieberman 03/07/2010 62.3 KB
Feature Article: Demonstrating Comparability For Well-Characterized Biotechnology Products Challenges and approaches in demonstrating comparability of a well-characterized biotechnology product after manufacturing changes can be as varied and complex as the products themselves. Participants at the January 2005 CMC Strategy Forum sought to discuss and agree on common implementation strategies for different manufacturing change scenarios. By John Towns and Keith Webber 03/04/2010 252.8 KB
Feature Article: Integrating Modular Design — Build Execution Strategies Into Biotech Projects One of the earliest and most important decisions in a biopharmaceutical facility construction project is choosing a project execution strategy. This choice affects cost, schedule, and quality of the immediate project as well as further operations throughout the facility life-cycle. By Kevin L. Koffke and R. Grant Merrill 03/04/2010 317.2 KB
Case Study: Thermo Scientific CONNECTS At GPSG Brazil Delivers Enterprise-Level Productivity Linking Laboratories To ERP Pharmaceutical manufacturing companies such as GPSG Brazil are required to control the quality of their analyses according to specific US FDA guidelines, which apply to electronic format records that are created, modified, maintained, archived, retrieved or transmitted in their laboratories. These regulations are valid even for records that are not used in a submission, such as training records and SOPs. By Thermo Scientific Brand Products, Part of Thermo Fisher 03/04/2010 1.08 MB
Poster: Promega’s ADP-Glo™ Kinase Assay Performed On BMG LABTECH’s PHERAstar FS And POLARstar Omega BMG LABTECH presented the poster Promega's ADP-Glo Kinase Assay performed on BMG LABTECH's PHERAstar FS and POLARstar Omega at LabAutomation 2010. In this poster we discussed the ability of the PHERAstar FS as well as the POLARstar Omega to perform the ADP-Glo™ assay from Promega in a 384-well format. By BMG LABTECH, GmbH 03/03/2010 370.4 KB
Technical Bulletin: Thermo Scientific Nalgene InVitro Biotainers Thermo Scientific Nalgene InVitro Biotainers are safe, sterile, single-use containers ideal for storage, transport and freezing applications of critical reagents and bulk intermediates such as vaccine and protein therapeutic preparations. 03/02/2010 462.2 KB
Application Note: In-Situ Micro-Volume Bicinchoninic Acid Protein Assay Standard protocols for bicinchoninic acid (BCA) assays using vials or microplates have been modified for use with the Take3™ Multi-Volume Plate suitable for micro-volume analysis. Protein samples and BCA working reagent are added sequentially directly to the microspots of the Take3 plate, incubated, then read on the Epoch™ Multi-Volume Spectrophotometer. By Peter Brescia, MSc. and Peter Banks, Ph. D., BioTek Instruments, Inc., Winooski, VT 03/02/2010 173.4 KB
Article: How To Improve Your Implementation Of Two-Dimensional Preparative HPLC The biologics and natural product industries rely heavily on separation technology. Sample analyses are undertaken on the analytical scale, and isolation and purification are undertaken at the preparative scale. Key target components are often isolated to provide standard reference materials for future product quality assurance testing. By R. Andrew Shalliker and Georges Guiochon 02/26/2010 404.9 KB
Datasheet: Early Formulation Development Patheon and Solvias AG have partnered to provide customers with integrated early development services. 02/26/2010 820.6 KB
Datasheet: Cytotoxic Contract Manufacturing BSP is a partner alliance of Patheon, providing solutions to develop and manufacture high potency cytotoxic products. 02/26/2010 784.9 KB
Podcast: Redefining The CRO Listen to Bob Burford Ph.D. Managing Director, Aptuit Consulting. 02/25/2010 6.17 MB
Datasheet: Low Solubility Compounds For tackling the bioavailability challenges of BCS (Biopharmaceutical Classification System) class II and IV compounds, proven formulation development, analytical and manufacturing capabilities are available at Patheon’s facilities. 02/25/2010 749.8 KB
Datasheet: Pharmaceutical Drug Delivery AcuForm™ technology has a proven track record of once-daily dosing, improved treatment tolerability, and enhanced patient compliance. It can be a preferred delivery system for new chemical entities, or a differentiating formulation for life cycle management. 02/25/2010 853.0 KB
Podcast: The Role And Importance Of Informatics In Today's Clinical Trial Environment Listen to Doug Meyer, Senior Director for Aptuit Informatices, discussing the role and importance of informatics in today's clinical trial environment. 02/25/2010 12.91 MB
Datasheet: Pharmaceutical Analytical Development Our analytical chemists will develop and validate laboratory methodologies for your new active pharmaceutical ingredient or product, and then monitor its ongoing stability. At Patheon, we support every step of the formulation and clinical manufacturing process. 02/25/2010 827.1 KB
Podcast: Molecular Design As A Strategy For Solving The Critical Path Problem Listen to Stephen Bryn, Ph.D., Chairman of the Aptuit SAB & Professor Purdue University. 02/25/2010 7.58 MB
Datasheet: Cephalosporin Contract Manufacturing Patheon is one of a select number of outsourcing companies to offer dedicated sterile cephalosporin manufacturing facilities for a range of dosage forms. 02/25/2010 751.3 KB