When a clinical trial requires local or point-of-care laboratory testing, managing the resulting data can be a significant burden to both the sponsor and...
Frontage Laboratories | 01-Dec-2019
| Technical / White Paper
Biologics are complex large molecules derived from living organisms or manufactured from cells, and they have inherent structural heterogeneity. Indeed,...
Frontage Laboratories | 01-Oct-2019
| Technical / White Paper
Over the years, the pharmaceutical industry has made steady progress in improving the safety of drugs in development. Consequently, in 2015, only 14 percent...
Frontage Laboratories | 01-Oct-2019
| Technical / White Paper
Frontage is the first and only laboratory to validate Quanterix’ Simoa HD1 Analyzer for performing immunoassays. Most of the advanced instruments used...
Frontage Laboratories | 21-Aug-2019
| Technical / White Paper
Immunogenicity is the leading reason that biologics fail in clinical trials, and thus it has become imperative for drug development programs to include...
BBK Worldwide | 24-Jul-2019
| Technical / White Paper
Despite growing evidence, the myth that physicians won’t refer patients to clinical trials persists, perpetuated by the belief that they fear losing their...
In May 2018 Outsourcing-Pharma.com, in association with InnovoCommerce, conducted its second annual ‘state of the industry’ survey on its user base of...
You have the power to make a difference. To make new therapeutics that improve quality of life and inspire a healthier world. To do this, you need a manufacturing...
The data used to determine the success of a cleaning validation is built upon both the effective evaluation of the manufacturing plant and the robustness...
Butterworth | 26-May-2016
| Technical / White Paper
The International Conference of Harmonisation (ICH) guidance document on elemental impurities, Q3D, reached step 4 in December 2014, meaning the final...
Butterworth | 24-Sep-2015
| Technical / White Paper
The classic Modified Atmosphere Packaging (MAP) application, in the pharmaceutical industry, uses medical grade nitrogen to purge atmospheric oxygen and...
ACM Global Central Laboratory | 19-May-2015
| Clinical Study
Until recently, sponsors and CROs engaged their central laboratory simply for routine safety testing. However, as clinical trial protocols have grown in...
Butterworth | 12-May-2015
| Technical / White Paper
Samplestorage, handling anddelivery are as important in the determination of residual solvents as the analysis itself. This paper provides practical advice...
Merge eClinical | 01-Apr-2015
| Technical / White Paper
Intense competition in the prescription drug market is driving pharmaceutical companies to expedite their drug discovery and development processes. Pharmaceutical...
Merck KGaA, Darmstadt, Germany | Recorded the 09-Apr-2015 | Webinar
Pyrogens in pharmaceuticals, medical devices, biotherapeutics and cosmetics can cause fevers in humans and are potentially life-threatening. Yet standard...
Butterworth | 27-Jan-2015
| Technical / White Paper
The European Pharmacopeia (Ph Eur) is moving away from the historical thin layer chromatography technique for the determination of Ninhydrin-positive substances,...
World Courier | 24-Nov-2014
| Technical / White Paper
The BRIC nations will account for $248 billion in pharmaceutical Sales by 2016. Global Pharma will spend $8 billion on cold chain logistics in 2014 These...
The role of the Qualified Person (QP) in the pharmaceutical industry is mandated by law. Every holder of a relevant Manufacturers Authorisation (human...
The recently introduced EU Guidelines on the Good Distribution Practice of Medicinal Products for Human Use, (first published on March 8th 2013 as 2013/C...
World Courier is continuously looking out for trouble on a local and global scale. Areas of conflict that might affect transport routes? A hurricane?...
Almac Group | 04-Aug-2014
| Technical / White Paper
UNDERSTANDING THE CHALLENGES OF TEMPERATURE CONTROLLED INVESTIGATIONAL MEDICINAL PRODUCT DISTRIBUTION IN EMERGING MARKETSTemperature deviation within the...
ACM Global Central Laboratory | 17-Jun-2014
| Clinical Study
Metabolic syndrome, a serious condition impacting adults and children in all genders, races and ethnicities, can lead to fatal outcomes if not detected...
Marken’s new customs-bonded warehouse within the Marken depot in Frankfurt, Germany allows Marken to store pharmaceuticals with an origin outside the European...
Butterworth | 06-May-2014
| Technical / White Paper
A method to identify the presence of heavy metals in pharmaceuticals was introduced in the United States Pharmacopoeia more than 100 years ago. Today pharmaceutical...
Vetter Pharma International GmbH | 15-Apr-2014
| Technical / White Paper
Realizing the full potential of an injectable drug compound is no small task. In the months and years that lead from the discovery phase to the rigorous...
Information not available | 13-Feb-2014
| Technical / White Paper
Altering the genome of cells is a powerful and increasingly necessary tool for drug discovery and research. Transposagen utilizes its expertise and a diverse...
With proposed changes to elemental impurities requirements for pharmaceutical products currently being reviewed, spectroscopic techniques for metals analysis...
Information not available | 28-Oct-2013
| Case Study
Metrics provides product development that leverages proprietary pharmaceutical technologies in the areas of: • Customized Controlled Release Drug Delivery...
Exploring New Frontiers in Direct to Patient (DTP) Home Delivery Services for Clinical Trial Materials provides an in-depth look at reasons to consider...
SGS Life Science Services | 26-Mar-2013
| Technical / White Paper
The goal of method validation is to provide proof that data from each individual sample is indicative of the actual batch content with little deviation....
With current glass slide methods, sharing and scoring slides within a study from one pathologist to another at a different organization or site, meant...
SGS Life Science Services | 03-Dec-2012
| Technical / White Paper
Sterility testing is required for companies producing pharmaceutical products and consistent and meticulous testing is essential to obtain results that...
Pharmaceutical drug product development can be an expensive and time consuming process. Many challenges are faced by pharmaceutical development companies...
SGS Life Science Services | 19-Nov-2012
| Technical / White Paper
Development of influenza vaccines is critical; but, there is also a need for new influenza treatments. This article presents an overview of challenges...
SGS Life Science Services | 22-Oct-2012
| Case Study
An extractables and leachables case study describes how a comprehensive risk assessment was performed across the entire production process of a European...
SGS Life Science Services | 03-Sep-2012
| Technical / White Paper
There is an urgent need to use innovative techniques in early development. This paper will discuss several case studies in which new clinical trial methods...
SGS Life Science Services | 09-Jul-2012
| Technical / White Paper
Download this paper to read two case studies which illustrate strategies for planning and implementing a vaccine-based infectious disease clinical trial...
SGS Life Science Services | 27-Feb-2012
| Technical / White Paper
Proper sample preparation is crucial when analyzing for trace metals using inductively coupled plasma (ICP). This paper illustrates how solubility of the...
SGS Life Science Services | 22-Feb-2012
| Technical / White Paper
The sudden appearance of an unknown peak during an HPLC analysis of a pharmaceutical product can be a critical finding causing delays and requiring considerable...
SGS Life Science Services | 24-Jan-2012
| Technical / White Paper
With many new challenges in early clinical development there is pressure to change how early phase clinical trials are conducted where the final goal is...
SGS Life Science Services | 06-Dec-2011
| Technical / White Paper
Glycosylation is one of the most widely observed, and structurally diverse, forms of post-translational modification of proteins and glycans have been...
SGS Life Science Services | 07-Nov-2011
| Technical / White Paper
Early identification and management of emerging drug safety issues are a major concern of industry stakeholders. Electronic capture systems for AE reporting...
SGS Life Science Services | 26-Sep-2011
| Technical / White Paper
Download this paper to read two case studies which illustrate strategies for planning and implanting a vaccine-based infectious disease clinical trial...
SGS Life Science Services | 30-May-2011
| Technical / White Paper
This paper gives the essential background to understanding biopharmaceutical characterization by mass spectrometry and its importance in accelerating the...
CDC Software | 10-Sep-2010
| Technical / White Paper
Many factories are currently engaged in many cost reduction initiatives that are stumbling or have dramatically slowed down. In many cases they continue...
Exploristics | 25-Aug-2010
| Technical / White Paper
Quality of Life, Patient Reported Outcomes, Composite Endpoints and Clinical Ratings Scales have important applications in clinical research and practice....
CDC Software | 17-Aug-2010
| Technical / White Paper
Increasing evidence is pointing to the realization that many plant-wide intelligence initiatives do not lead to the dramatic improvements that the business...
William Reed | 02-Aug-2010
| Technical / White Paper
White papers (or technical papers) are one of the most effective ways to generate leads for your sales team and establish your company’s reputation as...
BASi’s expanded European facility provides contract research services — preclinical, toxicology, bioanalytical, method development and pharmaceutical analysis...
William Reed | 24-Mar-2010
| Technical / White Paper
White papers (or technical papers) are one of the most effective ways to generate leads for your sales team and improve your company’s reputation as an...
