Product innovations > Technical Papers
Data sheet
Effective Controlled Substances Supply Chain Management - DPT Labs
23-May-2012 -
At a time when supply chain management has become increasingly complex, managing the unique challenges of the controlled substance supply chain can seem daunting for companies lacking in‐house capabilities and resources. Effective management of the controlled substance supply chain and...
Technical / white paper
Clinical Trial Logistics in Africa: Ensuring Quality, Compliance and Control within the Pharmaceutical Supply Chain - World Courier
01-May-2012 -
WORLD COURIER is the market leader in the handling, transport, storage and distribution of temperature-sensitive pharmaceutical products and biological specimens in Africa and worldwide. It offers a fully-integrated GxP-compliant pharmaceutical supply chain system, strong knowledge of the local regulatory environment,...
Technical / white paper
The new product development reality - Parexel
23-Apr-2012 -
While winning FDA or other regulatory approval is a formidable hurdle, it is no longer the end game when it comes to defining if the development of a product is truly successful. In today's health care reality, the new finish...
Technical / white paper
Implementing LEAN Techniques in Quality Control - Baxter
17-Apr-2012 -
Applying LEAN techniques can result in improved productivity, workflow efficiency and cost savings. The Quality Control Laboratory at Baxter’s contract manufacturing facility in Halle/Westfalen, Germany, has been applying LEAN techniques since 2007 with the goal of reducing release lead times....
Technical / white paper
A Clinical Perspective on IV Medication Delivery - Baxter
09-Apr-2012 -
Management of medication delivery through intravenous (IV) administration is a complex and challenging task for pharmacists. The information provided reflects research conducted assessing medication delivery practices and preferences.
Technical / white paper
SGS-Clinical-Influenza Clinical Trials… - SGS
02-Apr-2012 -
Development of influenza vaccines is critical; but, there is also a need for new influenza treatments. This article presents an overview of challenges faced when conducting an influenza treatment study based on two recently managed clinical trials.
Technical / white paper
Sample Prep Proposed USP<233> Elemental Impurities - SGS
27-Feb-2012 -
Proper sample preparation is crucial when analyzing for trace metals using inductively coupled plasma (ICP). This paper illustrates how solubility of the test article may not be the primary factor when choosing a sample preparation method.
Technical / white paper
How to Approach Identification of Anomalous Peaks - SGS
22-Feb-2012 -
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 resources to resolve. The unknown peak can be caused by many things ranging from simple...
Technical / white paper
The Scientific Path to Cycle Development - Baxter
20-Feb-2012 -
To optimize lyophilization cycle times and improve stability for complex injectables, Baxter’s BioPharma Solutions contract manufacturing business established the Lyophilization Center of Excellence, an industry-leading resource for development of high-quality freeze drying.
Data sheet
Overcoming the Challenges of Clinical Trial Supply Distribution - Almac Group
15-Feb-2012 -
The distribution of clinical supplies globally can be a challenge for any trial, especially with many new emerging markets. Almac Clinical Services provides contract services to the clinical trial supply industry serving both Pharmaceutical and Biotech companies worldwide and has...
Data sheet
Ensuring Quality & Regulatory Compliance w/ Service Providers - DPT Labs
25-Jan-2012 -
In recent years, the pharmaceutical industry has given greater priority and attention to quality assurance and regulatory compliance than ever before. With the FDA’s heightened focus on safety, regulatory agencies are increasing their presence in the manufacturing arena to ensure...
Technical / white paper
New Challenges in Early Clinical Development - SGS
24-Jan-2012 -
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 to shorten the time to go-no-go decisions and decrease cost. It is increasingly important to...
Technical / white paper
Risk-Reducing Solutions for Global Study Logistics - World Courier
01-Jan-2012 -
Dr. Rüdiger Lomb, Global Director, Quality & Technical Compliance for World Courier, discusses the merits of using a fully-integrated closed-loop supply chain system to improve compliancy and reduce risk in keeping with current ICH requirements.
Technical / white paper
Glycosylation of Proteins: Structure & Analysis - SGS
06-Dec-2011 -
Glycosylation is one of the most widely observed, and structurally diverse, forms of post-translational modification of proteins and glycans have been shown to have a range of specific biological roles. Mass spectrometry-based techniques provide an extremely powerful tool for glycan...
Technical / white paper
Crystallization – Understanding and developing the process - Solvias AG
28-Nov-2011 -
In order to achieve controlled production of a desired polymorphic form it is essential to primarily understand the product and be intimately familiar with the process. Furthermore, scaling up the crystallization process requires an expert team of experienced scientists working...
Case study
Application of a partner-driven approach in winning and maintaining outsourced pharmaceutical business - Alkermes
17-Nov-2011 -
Alkermes' Contract Pharma Services provides solid dosage form product development, formulation solutions and manufacturing services for the pharmaceutical market. With a long and successful history in the development and manufacture of pharmaceutical dosage forms for pharmaceutical markets worldwide, previously as...
Technical / white paper
Characterisation of Biopharmaceutical Proteins -
14-Nov-2011 -
Over the next five years it is anticipated that there is going to be an explosion in the numbers of biosimilar products coming to market as patents expire. This paper describes the array of the more common techniques used in...
Technical / white paper
Improving Signal Detection in Drug Safety - SGS
07-Nov-2011 -
Early identification and management of emerging drug safety issues are a major concern of industry stakeholders. Electronic capture systems for AE reporting now allow for faster accumulation of data and the ability to perform complex analysis.
Technical / white paper
Using the Four Pillars to Support Data-Driven Feasibility Success - INC Research
03-Nov-2011 -
Download our latest Foresight articleThe challenges of clinical trial recruitment are well-known to drug developers. Yet while difficulties on the macro level are well-recognized, it is the micro-level details that ultimately determine the success or failure of enrollment efforts in...
Technical / white paper
Securing the Supply Chain: Third-Party Contingency Planning for Clinical Trial Transport - World Courier
01-Nov-2011 -
WORLD COURIER is widely recognized as the largest and most experienced specialty courier service with a network of 150 company-owned GxP-compliant, ISO 9001-certified offices operating in 51 countries worldwide. Its superior transport network is complemented by 13 state-of-the-art and fully...