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Latest White Papers
Early Phase Research
| By Pierrel Research
Comprehensive Expertise from First-In-Human through Proof-Of-Concept. Pierrel Research Early Phase experts team from First-In-Human through Proof-Of-Concept provides integrated solutions in strategic clinical drug development and its implementation.
Contract Research & Services > Contract Research > White Papers
ECG Assessments During the Development of Oncology Compounds
| By PRA Health Sciences
Assessment of ECGs during the development of oncology compounds is challenging. Toxicity of these compounds often precludes the inclusion of healthy volunteers while a higher variability of ECG parameters in oncology patients can be expected due to disease, comedication, and co-morbidities. Recently, it was shown that the extraction of ECG data using the High Precision QT technique of iCardiac and Exposure Response analysis can result in a conclusive ECG assessment with a limited number of volunteers. Applying these techniques in a small-sized oncology study with dedicated PRA staff presents a unique opportunity for a conclusive and efficient cardiac safety assessment by ECG.
Contract Research & Services > Contract Research > White Papers
Effect of Excipients on Protein Formulation Viscosity
| By Malvern Instruments
In the development of injectable biotherapeutics, drug efficacy and patient experience are both very important parameters. In order to maximize activity and efficacy, biotherapeutics are usually delivered intravenously or subcutaneously in high concentrations, typically >100g/mL, due to their short half-life in plasma.
White Papers
Effective Photo Stability Testing
| By BINDER Pharma
Photo stability testing is important in developing and manufacturing a wide range of products for some or all of the following reasons. Outside of the necessary guidelines, unfavorable appearance, recessive or misaligned efficacy, physical changes, chemical changes and microbiological changes are some the important factors that must be looked at.
Production & Manufacturing > Process & Production > White Papers
Effectively Outsourcing Medical and Laboratory Equipment Procurement
| By Woodley Equipment Company
With investigator sites located across the globe, it is increasingly important to ensure that they all have the right equipment to undertake a clinical trial to its successful conclusion. Robin Wickham, general manager, explains how Woodley Equipment Company can source the most appropriate equipment for you, and ensure a smooth trial is delivered on time and in budget.
Contract Research & Services > Clinical Trials > White Papers
Efficient SEC-UV-RI-MALS Analysis of Protein Aggregates
| By Tosoh Bioscience
Static light scattering in combination with size exclusion chromatography is a valuable tool for verifying purity of monoclonal antibodies (MABS) as such or as a quick check while the downstream processing takes place. Besides fluorescence detection, light scattering is one of the most sensitive methods to detect protein aggregates.
Drug Research > Drug Discovery & Development > White Papers
Elemental Impurity Analysis in Pharmaceuticals
| By Butterworth Laboratories Ltd
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 companies are still using essentially the same method, the USP <231> Heavy Metals Limit Test. This paper will give an overview of the current method limitations, considerations for the new methodology and the risk-based assessments being carried out by manufacturers.
White Papers
Elemental Impurity Analysis in Pharmaceuticals – The Road To Implementation of ICH Q3D
| By Butterworth Laboratories Ltd
Elemental impurities have been a hot topic since 2009 when the International Conference of Harmonisation (ICH) commenced work on a new standard to provide a global policy to limit these impurities in drug products and ingredients. Their guidance document, Q3D, reached step 4 in December 2014, meaning the final draft is recommended for adoption to the regulatory bodies of the European Union, Switzerland, Japan, USA and Canada.
White Papers
ELISPOT Assays Provide Reproducible Results Among Different Laboratories for T-cell Immune Monitoring - Even in Hands of ELISPOT's Inexperienced Investigators
| By CTL Laboratories
Measurements of antibodies in bodily fluids (e.g., by ELISA) have provided robust and reproducible results for decades and such assays have been validated for monitoring of B-cell immunity. In contrast, measuring T-cell immunity has proven to be a challenge due to the need to test live cells in functional assays ex vivo. Several previous efforts looking into the reproducibility of ex vivo T-cell assays between different laboratories, or even within the same laboratory, have provided rather discouraging results.
Contract Research & Services > Clinical Trials > White Papers
Enabling Drug Delivery Deal Making
| By Aveva Drug Delivery Systems
Transdermal drug delivery: Time for a closer look. To find out more download this free white paper.
Production & Manufacturing > Manufacturing > White Papers
Enhanced Aggregate Detection: Monitoring
| By Malvern Instruments
The high sensitivity of dynamic light scattering (DLS) to protein aggregation explains the wide use of Zetasizer instruments within the biopharmaceutical industry. Since the amount of light scattered by a particle is proportional to size, trace amounts of aggregate can be detected and sized using DLS.
White Papers
Enhanced Residual Solvents Analysis: A Practical Approach to Sampling, Transport, Storage and Analysis.
| By Butterworth Laboratories Ltd
Residual solvents are organic volatile chemicals used or produced in the manufacture of active pharmaceutical ingredients (API), excipients or drug products, which remain in the material at the end of the manufacturing process. Their control is important in limiting exposure and guidelines exist to maintain patient safety, not just to satisfy competent authorities. It is a requirement that all pharmaceutical substances comply with ICH limits even if not required by individual monographs or if no compendial monograph exists.
White Papers
Enhanced Sampling and Calibration Procedures for the Analysis of Residual Oxygen in Nitrogen Purged Pharmaceutical Packaging by GC-TCD
| By Butterworth Laboratories Ltd
In recent times there has been a large increase in the type and number of products packaged using Modified Atmosphere Packaging (MAP) procedures. The majority of these processes concern the removal of oxygen from packaging systems in order to reduce oxidative degradation of the product and increase shelf life. Whilst most of the historical development of MAP took place within the food industry, over the last 20 years there has been a large growth in its application within the pharmaceutical sector.
White Papers
Ensuring Accurate and Repeatable Measurement of Proteins Using the Zetasizer APS
| By Malvern Instruments
In this application note, well known protein samples were used in a crosscontamination test to investigate the accuracy and repeatability of the Zetasizer APS dynamic light scattering (DLS) system.
White Papers
Ensuring Trial Validity by Data Quality Assurance and Diversification of Monitoring Methods
| By CluePoints
Errors in the design, the conduct, the data collection process, and the analysis of a randomized trial have the potential to affect not only the safety of the patients in the trial, but also, through the introduction of bias, the safety of future patients. Trial monitoring, defined broadly to include methods of oversight which begin when the study is designed and continue until it is reported in a publication, has a role to play in eliminating such errors.
Contract Research & Services > Clinical Trials > White Papers
Enyzme Application Table
| By Johnson Matthey Fine Chemicals
Johnson Matthey Catalysis and Chiral Technologies provides an extensive set of biocatalysts providing a focused library resulting in quicker screening and maintaining a high hit rate standard. Every enzyme in our kit is 100% reproducible and available at commercial scale. More details on the reactions and products can be found online at: www.jmcct.com
Production & Manufacturing > Fine & Speciality Chemicals > White Papers
ePRO Helps Sponsors Deliver a More Patient-Centric Study
| By CRF Health
There is now a greater demand for patient input during clinical research, with many more clinical studies collecting patientreported outcome (PRO) data.
Contract Research & Services > Contract Research > White Papers
ePRO Migration and Usability Testing of Patient-Reported Outcome (PRO) Measures.
| By RWS Group
A paper by PharmaQuest (a member of the RWS Group) and Isis Outcomes.
White Papers
Estimating BSA Aggregation Kinetics with Dynamic Light Scattering and Raman Spectroscopy
| By Malvern Instruments
Towards a unified biophysical characterization platform: Combining dynamic light scattering and Raman spectroscopy*.
White Papers
Evaluating Product Delivery Characteristics from a Bottle, Tube or Spray Pack
| By Malvern Instruments
Many consumer products are packaged in tubes or bottles where product application involves pumping the product through a nozzle. Such products tend to be shearthinning products where the viscosity drops during the extrusion process due to the increasing shear rate, and then recovers on exiting the nozzle as the shear rate is reduced.
White Papers
Evaluating Product Texture Using Oscillatory Testing on a Rotational Rheometer
| By Malvern Instruments
Formulating products to have both the correct functional and sensory attributes can be a difficult task. The latter in particular relies heavily on user feedback which can take considerable time and effort to attain. In addition it is not always easy to interpret such feedback in the context of material properties and hence rheological data.
White Papers
Evaluating the Rheological Properties of Hyaluronic Acid Hydrogels for Dermal Filler Applications
| By Malvern Instruments
Hyaluronic acid (HA) is a naturally occurring polysaccharide frequently used as a functional ingredient in many topical and subcutaneous anti-ageing treatments such as dermal fillers, which exploit the polymer’s unique viscoelastic properties for effective soft tissue augmentation. When administered subcutaneously, HA builds an elastic network within wrinkles and rhytides to give the skin a plumper and fuller look.
White Papers
Evaluation of the BioFlo® 320 Process Capabilities
| By Eppendorf
This poster characterizes the capabilities of the BioFlo320 in terms of key process parameters including oxygen transfer rate (OTR), volumetric mass transfer coecient (kLa), tip speed, mixing time, and water consumption. These data enable quantitative analyses of bioprocess engineering parameters, thus allowing potential users to gain insight into the system’s cell culture and fermentation capabilities.
White Papers
Exhibit at Pittcon - the Magnet for Scientific Innovation
| By Pittcon
Pittcon is the leading showcase for scientific and technical innovation. Thousands of conferees from around the world visit Pittcon each year to evaluate new products and technologies, formulate purchase decisions and make valuable business connections. There is no better place to pursue laboratory business opportunities. To find out more, download this free brochure.
White Papers
Exosomes and Microvesicles: Characterisation by Nanoparticle Tracking Analysis
| By Malvern Instruments
While the principles underpinning the Nanoparticle Tracking Analysis (NTA) technique have been described in an earlier white paper, it must be reiterated that the use of high intensity laser beams combined with a low-background optical configuration allows particles of deeply sub-micron dimensions to be visualised, the lower range of particle sizes measureable depending on particle refractive index.
White Papers
Exosomes and Microvesicles: Characterization by Nanoparticle Tracking Analysis
| By Malvern Instruments
NTA utilizes the properties of both light scattering and Brownian motion in order to obtain the particle size distribution of samples in liquid suspension. A laser beam is passed through the sample chamber, and the particles in suspension in the path of this beam scatter light in such a manner that they can easily be visualized via a 20x magnification microscope onto which is mounted a camera.
White Papers
Extending the Boundaries of QbD
| By Malvern Instruments
The last decade has seen a shift within the pharmaceutical industry towards a design space approach to development and manufacture, an agenda underpinned by ICHQ8, Q9 and Q10 and the concept of Quality by Design (QbD). However, because a design space approach naturally focuses attention on the areas of a project that are potentially the most vulnerable to failure it has broader value for risk management.
White Papers
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