Library > Technical Papers
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...
Technical / white paper
Container Testing: Quantifying Metal Contaminants - SGS
18-Oct-2011 -
Regulatory Agencies have clearly established the need to identify and control harmful chemicals which may leach from container closure systems into the final packaged drug product. But USP <661> colorimetric methods for detecting heavy metal contaminants are known to be...
Data sheet
Camargo: Paws-Down, Your 505(b)(2) Experts - Camargo
17-Oct-2011 -
The 505(b)(2) pathway can lead to approval for new drugs in a fraction of the time and cost required by traditional paths; but special requirements demand a thorough understanding of the FDA and its evolving standards. See us at AAPS...
Technical / white paper
Clinical Trial Logistics in Africa: Ensuring Quality, Compliance and Control within the Pharmaceutical Supply Chain - World Courier
01-Oct-2011 -
In the area of clinical trials, WORLD COURIER delivers unprecedented expertise 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...
Technical / white paper
White Paper: Vaccine-Based Clinical Trials - SGS
26-Sep-2011 -
Download this paper to read two case studies which illustrate strategies for planning and implanting a vaccine-based infectious disease clinical trial versus a therapeutic-based trial.
Technical / white paper
Ensuring Clinical Trial Success in the Russian Federation: Strategies to Manage Temperature-Controlled Logistics - World Courier
01-Sep-2011 -
In the area of clinical trials, WORLD COURIER delivers unprecedented expertise in the handling, transport, storage and distribution of temperature-sensitive pharmaceutical products and biological specimens throughout Russia and worldwide. It offers a fully-integrated GxP-compliant global pharmaceutical supply chain system, strong...
Technical / white paper
Clinical Trial Logistics in India: Managing Distribution Timelines through the Efficient Importation of Investigational Drugs - World Courier
25-Jul-2011 -
In the area of clinical trials, WORLD COURIER delivers unprecedented expertise in the handling, transport, storage and distribution of temperature-sensitive pharmaceutical products and biological specimens throughout India and worldwide. It offers a fully-integrated GxP-compliant pharmaceutical supply chain system, strong knowledge...
Data sheet
Overcoming the Challenges of Clinical Trial Supply Distribution - Almac Group
16-Jun-2011 -
Overcoming the Challenges of Clinical Trial Supply DistributionThe distribution of clinical supplies globally can be a challenge for any trial, especially with many new emerging markets. Almac Clinical Services, a provider of contract services to the clinical trial supply industry...