Thermo Scientific Cell Culture and Bioprocessing The Thermo Scientific HyClone product line in Logan, Utah helps to make the world healthier, cleaner and safer by producing leading cell culture products and bioprocessing systems for life-science research and...
Blue Heron Biotechnology, Inc. Blue Heron Biotechnology synthesizes full length, double stranded, cloned and sequence verified DNA for research use. From 1999 to 2009, Blue Heron Biotechnology has delivered tens of millions of base pairs of perfectly...
Codon Optimization Tool
Blue Heron Biotechnology's customers have a powerful Optimization for Expression Tool available at no extra charge to assist in sequence design.
Invensys Process Systems Invensys Operations Management is a leading provider of automation and information technologies, systems, software solutions, services and consulting to global manufacturing and infrastructure industries. The marketplace...
ERCFW08 Series
ERCFW08 VSDs are easy to install and operate. They are equipped with optimized software that can easily be configured through a keypad, enabling the drives...
ICTS (Integrated Clinical Trial Services, LLC). At ICTS, we believe that clinical trials are first and foremost about people. The better each person associated with a study is connected to it through clear, concise and intelligent communication, the more successful...
Size Optimization
ICTS diligent planning and implementation is designed to provide sites with the knowledge of best practices and the tools to get the job done quickly.
Zyleris Pharmatech Zyleris is specialized in developing innovative high-throughput experimentation technologies for topical and transdermal formulation development.
Apriso Apriso Corporation is a software company dedicated to providing competitive advantage for its customers. It does so by enabling organizations to adapt quickly and easily to market changes and unexpected events. Apriso’s...
CARBOGEN AMCIS CARBOGEN AMCIS exists to provide innovative solutions for drug development and supply to the pharmaceutical and biopharmaceutical industries that enable customers to bring new generation medicines to market.
We are...
Process Optimization and cGMP Manufacturing
Process optimization skills are critical in ensuring a safe and efficient scale-up from development scale to routine cGMP and eventual commercial API...
Previously, four HPLC-MS/MS methods using two columns with multiple injections were used to monitor nine CYP P450 Isozyme activities (Method I). Using this method was not efficient or cost effective. Therefore one optimized HPLC-MS/MS method (two ionization modes) was developed to monitor the activities of all nine Isozymes (Method II).
Frozen pooled (male and female) human liver microsomes ...
Pharmaceutical and biotech companies of all sizes are increasingly turning to third parties to execute some or all of their clinical supply activities. There is a need for these companies to control and track these activities in their information systems.
This article addresses the various methods in which the activities of third-party supply contractors and IVRS (Interactive Voice Response ...
Master Data Management Looking for the Pharmaceutical Solution
Property of Advantage Management Solutions, Inc 2008
Integrated data will provide Actionable benefits such as:
• Improved Marketing Analytics • Accurate Territory Alignment • Improved Sample Optimization • Accurate Call Plans • Field Force data confidence • Reduced postage • Multiple customer views • Reduced Data Steward ...
People who live and breathe maintenance every day are instinctively aware of the benefits of maintenance improvement: lowering costs and increasing output while still remaining compliant. The intent of this paper is to provide a framework for building the formal justification for investing in a CMMS (Computerized Maintenance Management System) or EAM (Enterprise Asset Management) system as part ...
The voluntary certification of a quality management system, specifically for medical devices, to ISO 13485 proves advantageous, and in many cases essential, for medical companies which export their products in the global market.
In the European Union, the fulfillment of EU Directives (e.g., Active Implantable Medical Device Directive, Medical Device Directive and In Vitro Diagnostic Directive) ...
This technical whitepaper describes the optimization of a simple motion profile based on construction of a physical system model using a simple spreadsheet. While the approach, model, and tools described in this paper are very general and can be applied to any basic motion optimization, here we focus on a specific motion optimization process recently completed for a specific DMC Client, the ...
Enterprises need to store more information, and more types of information, for longer periods of time than ever before. They need to ensure that this information is safely retained in the near term for rapid recovery and over the long term to enhance corporate governance. IT managers are demanding families of storage solutions, both hardware and software, that allow them to deploy complementary ...
The purpose of this white paper is to document and summarize the current status of the regulatory requirements set forth by different agencies like FDA (in US), ICH (in Europe), and that of Japan and China. In the first section of the paper we will provide the background information on the role of FDA, the regulatory agency in the USA, and the current state of cGMP “risk based approach” enforced ...
● Determine and quantify system noise as a function of instrument dwell time ● Demonstrate precision limits of quantification due to instrument noise ● Examine the relationship between dwell time and instrument contamination
● Model analyte for all experiments was paclitaxel, M.W. 854 Da, MRM transition 854>286 Da, HPLC mobile phase ACN/water/formic acid ● Data collected on Micromass Quattro ...
Rapid, Sensitive, General-Purpose Cleaning-Verification HPLC Methods Using Fused-Core™ Particle (FCP) Columns on Conventional Instrumentation S. Bannister1, M. Talbott1, F. Hanciles1, R. Henry2 1Xcelience LLC, Tampa, FL; 2Consultant, State College, PA
This work was undertaken to investigate the use of rapid gradients using recently introduced FCP columns on conventional instrumentation in the ...
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