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Latest White Papers
A Basic Guide to Particle Characterization
| By Malvern Instruments
The aim of this guide is to provide a basic grounding in the main particle characterization techniques currently in use within industry and academia. It assumes no prior knowledge of particle characterization theory or instrumentation and is ideal for those new to particle characterization, or those wishing to reinforce their knowledge in the field. The guide covers introductory basics, particle sizing theory and particle characterization instrumentation, as well as a quick reference guide to help you decide which techniques might be most appropriate for your particle characterization needs. It is not inclusive of all particle characterization techniques; more information can be found at www.malvern.com.
White Papers
A Guide to OEE - Overall Equipment Effectiveness
| By Garvens
Overall Equipment Effectiveness (OEE) is an important tool in the pharmaceutical industry. OEE improvement is a critical methodology to drive improved efficiency, higher quality and reduced cost. This white paper is intended to serve as a guide for professionals who are seeking to become more efficient and to utilise their processes more effectively.
Automation > Laboratory Instrumentation > White Papers
A Guide to Pharmaceutical Serialisation - Choosing the Right Equipment Supplier
| By Garvens
In the light that the world is facing a persistent and increasing threat from counterfeit, misbranded, adulterated, or diverted prescription drugs, equipment and methods to reliably track and trace prescription drugs are critical.
Automation > Laboratory Instrumentation > White Papers
A High Quality Formulation Development and Manufacturing Company
| By Alpex Pharma
Our predominant focus is the development of solid dosage forms to deliver drugs directly into the oral cavity in order to potentially improve both the bioavailablity of the drug as well as patient compliance and convenience to it. Alpex Pharma has 28 years of cGMP manufacturing experience and formulation development.
Drug Research > Drug Discovery & Development > White Papers
A New 384 Well Storage Plate Reducing Compound Consumption and Supporting Assay Miniaturisation
| By Greiner Bio-One
Technical notes and applications for laboratory work. Please download this free white paper for more information.
White Papers
A New Approach to Outsourced Drug Development
| By INC Research
A perfect storm is forming within the biopharmaceutical industry. With a growing number of blockbuster drugs losing patent protection, clinical research executives are under immense pressure to bring new drugs to market. As sponsor companies struggle to replace the revenue loss threatened by generics, drug development is becoming more complex and expensive.
White Papers
A New Tool for Fully Automated Dissolution Systems Integrated Video-Monitoring
| By Sotax
Automated dissolution testing systems have been used extensively in QC environments to increase productivity and reduce testing costs. For these same reasons, it has also become a matter of urgency for these same reasons in the Analytical R&D and formulation laboratories. SOTAX, the market leader in automated solutions for dissolution, content uniformity and assay testing, announces the integration of video-monitoring within our new client/serverWinSOTAX plus Dissolution Software.
White Papers
A short history of cell culture media and the use of insulin
| By Novo Nordisk Pharmatech A/S
The ancestors of cell culture media were the balanced salt solutions (BSS) devised by early workers interested in studying isolated organs ex vivo. The first BSS was composed in 1885 by Sydney Ringer (1836-1910), a British clinician and pharmacologist from University College London who worked on the isolated frog heart.
Production & Manufacturing > Manufacturing > White Papers
A Simple Mathematical Model Allowing for the Prediction of Drug Release from HPMC/Lactose-Based Controlled Release Matrix Tablets
| By MEGGLE
To use a simple mathematical model to quantify drug release from matrix tablets based on RetaLac®: a co-processed blend of 50% hydroxypropyl methylcellulose (HPMC) and 50% lactose monohydrate (mechanically inseparable). To use the model to quantitatively predict the impact of the formulation design on the resulting release kinetics and to evaluate the reliability of these simulations by independent experiments.
Production & Manufacturing > Fine & Speciality Chemicals > White Papers
A Statistical Approach to Central Monitoring of Data Quality in Clinical Trials
| By CluePoints
Classical monitoring approaches rely on extensive on - site visits and source data verification. These activities are associated with high cost and a limited contribution to data quality. Central statistical monitoring is of particular interest to address these shortcomings.
Contract Research & Services > Clinical Trials > White Papers
A Survival Guide to Temperature Data in Life Sciences, by Almac
| By Almac
Regulations continue to evolve globally within the distribution arena of the Life Sciences industry. Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01)1 as well as Good Distribution Practices Supply Chain Integrity2 has made the most significant impact. There is an increased focus on companies being able to prove the quality and integrity of their drug product throughout the entire supply chain. The industry is facing stricter compliance demands from regulations and regulatory agencies are not always given clear guidance.
White Papers
A Unique Solution for Generation of Reliable Intracellular Cytokine Staining Data
| By BD Biosciences
The BD FACSVerse™ system is a high-performance flow cytometer that incorporates easy-to-use, task-based workflows that streamline every stage of operation. A predefined assay module based on the BD FastImmune™ intracellular cytokine detection kits offers a quick and easy solution to generate reliable and consistent intracellular cytokine staining data. It can also be used as a starting point for creating custom assays. For more information please download this free Application Note.
Automation > Laboratory Instrumentation > White Papers
ABB Consulting - Safe, Reliable, Efficient Operations
| By ABB
Worldwide experience delivers world class performance. In today’s global process industries there is no room for outmoded practices or cherished traditions. Results count.
Production & Manufacturing > Process & Production > White Papers
Accurate Mass Measurement of High Concentration Samples by LCMS-IT-TOF
| By Shimadzu PBR
Time of flight (TOF) type mass spectrometers are used because they are capable of providing accurate high-resolution mass information. Mass accuracy for TOF analysers can deteriorate under certain conditions when analysing high concentration samples
White Papers
Achieving Cost and Process Efficiencies with Online Endpoint Coordination and Adjudication
| By Merge eClinical
Clinical trials increasingly rely on endpoint adjudication to better assess patient events and provide standardised endpoint classifications. The increased trend toward the use of endpoint adjudication in a wider variety of clinical trials is being driven by regulatory, clinical, business and technology trends:
White Papers
Addressing the Needs of Drug Discovery with the MicroCal PEAQ-ITC Instruments
| By Malvern Instruments
This white paper highlights the advantages of the new ITC instruments—MicroCal PEAQ-ITC and MicroCal PEAQ-ITC Automated systems and MicroCal PEAQ-ITC Analysis Software. The software allows analysis of binding interactions complicated by the presence of inactive protein material, incorrect protein concentration, and/or inaccurate concentration or heterogeneity of compound solutions.
White Papers
Adherent Packaging
| By MeadWestvaco MWV
Finding ways to reduce healthcare costs has never been more important; Ted Lithgow, President of MWV Healthcare puts the case for adherence-enhancing pharmaceutical packaging.
White Papers
All-Purpose Protein Sample QC Using a Novel Micro-Volume Platform with Spectral Content Profiling Software
| By Trinean
Accurate total protein quantitation of purified proteins, cell lysates, affinity-column fractions or other complex protein samples is crucial for robust biochemical testing during biopharmaceutical development as well as production. As the presence of chemicals doesn't allow simple A280 protein quantification, more labor-intensive alternatives for quantification are used. Examples are the colorimetric Bradford or BCA assay, which negate to a large extent the presence of contaminants but require multiple steps and show variation depending on the sample composition and time point of measuring within the ongoing reaction.
Drug Research > Drug Discovery & Development > White Papers
Almac Explores Interactive Response Technology: An Untapped Source of Historical and Real-Time Data for Risk-Based Monitoring
| By Almac
Risk-based monitoring has attracted the support of a diverse group of organisations in recent years. Regulators have released guidance encouraging the use of risk-based approaches to clinical trial quality, vendors have created technologies to support such methods, and large pharma companies have pooled their resources to drive adoption. Yet, despite this flurry of activity, the industry has overlooked a potentially useful source of real-time and historical data.
White Papers
Almac Presents Modern Perspectives on Peptide Synthesis, an Introduction
| By Almac
The complexity of synthetic peptide products, whether as reagents used in research or as therapeutic APIs, is increasing. As researchers understand more about the biochemical systems which are targeted, and invent ever more sophisticated products, manufacturing methods must keep pace. We look in this article at a number of challenging product classes, the specific problems they present, and potential solutions: Long peptides; Multi-peptide cocktails; Site-specifically modified products.
White Papers
Almac: Changing the Dynamics of Temperature Controlled Shipping Solutions
| By Almac
In the typical clinical trial today, the cost of shipping and distributing supplies accounts for approximately 60 percent of the overall clinical supply chain. And when the cost of product spoilage from temperature excursions is added into the mix, it is no wonder that pharmaceutical companies, Clinical Research Organizations (CROs), and logistics vendors are all eagerly searching for efficiencies and ways to carve costs out of the process.
White Papers
Almac: Crystallisation of Pharmaceutical Compounds
| By Almac
The Almac Group explores the chemist's role in protecting intellectual property. It provides development and manufacturing services for Active Pharmaceutical Ingredients (APIs) to pharmaceutical industries worldwide. Over the past 40 years, we have made numerous discoveries that have become powerful intellectual properties (IPs) for our customers.
White Papers
Alternate Selectivity for Polar Compounds in Hydrophilic Interaction Liquid Chromatography (HILIC) Using a New Amino Type HILIC Column
| By Tosoh Bioscience
Hydrophilic interaction liquid chromatography (HILIC) offers unique advantages for the separation of very polar compounds when compared to reversed-phase chromatography. A new silica based HILIC phase was developed to provide additional selectivity options in HILIC separations. The separation of water soluble vitamins on the new TSKgel NH2-100 HILIC column and on the well known TSKgel Amide-80 HILIC column demonstrates the differences in selectivity.
Drug Research > Drug Discovery & Development > White Papers
Amino Acid Analysis in Pharmaceuticals
| By Butterworth Laboratories Ltd
The European Pharmacopeia (Ph Eur) is moving away from the historical Thin Layer Chromatography technique (TLC) for the determination of Ninhydrin-positive substances, to more specific and sensitive methods utilising Liquid Chromatography (LC) or Amino Acid Analysers. This paper will explore the history of the test, the benefits of the change and considerations for validation of the LC approach to analysis.
White Papers
An Assessment of the Suitability of the Xcelodose 600 System in the Filling of Blended Products
| By Capsugel
In wall poster format, this study captures how Capsugel's Xcelodose 600 filling machine works with blended products. Complete with methods, results, diagrams, a conclusion and acknowledgements.
Production & Manufacturing > Fine & Speciality Chemicals > White Papers
An Introduction to DLS Microrheology
| By Malvern Instruments
Microrheology techniques involve tracking the motion of dispersed probe (or tracer) particles in a complex fluid, to extract local and bulk rheological properties of the matrix. Analogous to mechanical rheometry techniques, a stress is applied to the system by motion of the probe particle, and the deformation (or strain) is measured through changes in the probe particle position.
White Papers
An Introduction to OMNISEC RESOLVE
| By Malvern Instruments
This technical note describes the features and benefits of OMNISEC RESOLVE. It also includes a discussion of the value of OMNISEC as a complete system as opposed to upgrading an existing conventional system to advanced detection.
White Papers
An Introduction to OMNISEC REVEAL
| By Malvern Instruments
This technical note describes the system and explains how OMNISEC sets a new standard in molecular characterization.
White Papers
Analis: Powerful Solution for all Single Station R&D Presses
| By Medelpharm
Analis™ allows you to do the following: acquire all the data captured on your press, visualise your data, input additional information (hardness, out of die thickness, dissolution, etc.), export to another software, and use all the reporting and analysis tools included in the package.
Production & Manufacturing > Process & Production > White Papers
Analysis of cationic polymers by Size Exclusion Chromatography with TSK-GEL®
| By Tosoh Bioscience
In recent years water soluble cationic polymers are gaining more and more interest in different applications ranging from hair conditioning to gene transfection and drug delivery. The molecular weight distribution of polymers is usually characterized by SEC coupled with refractive index, viscometric or laser light scattering detection.
Drug Research > Drug Discovery & Development > White Papers
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