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Latest White Papers
Binders in Tablet Manufacturing – What You Need to Know
| By Spectrum Chemical
In this regard, selecting an appropriate binder becomes difficult because dissolution and binding properties oppose each other and a balance must be found. Furthermore, the effectiveness of the binder is not intrinsic, but is influenced by many other variables in the formulation components and process. This paper provides an overview of the popular choices available, as well as some considerations for optimal binder selection
Production & Manufacturing > Fine & Speciality Chemicals > White Papers
Understanding the true cost of projects
| By Malvern Instruments
Choosing the right approach for implementing on-line particle sizing. To read more, click here
White Papers
What NSF’s Remediation Projects Are Saying About the Industry
| By NSF Health Sciences Pharma Biotech PBR
NSF Pharma Biotech Consulting is in a unique position in that our team is regularly and intimately involved in a range of GMP remediation projects across the world and across all dosage forms. Offering companies a different perspective on current industry thinking or for us to review and verify that the proposed CAPA will be effective across the full range of key attributes. These attributes include cost, timeframe, GMP compliance, sustainability, simplicity and ease of presentation to clients and regulators.
White Papers
1.10 cDrop Protocol for TRIzol RNA Extract Quantification and Content QC
| By Trinean
This cDrop protocol is developed for specific RNA quantification of extracts from a variety of sample origins (human, animal, plant) using extraction kits based on the one-step extraction method using a guanidinium thiocyanate-phenol- chloroform reagent-mix developed by Chomczynski (1). Commercial available variants include the TRIzol® kit (Invitrogen), TRI Reagent® (MRC), RNAzolTM (MRC) and RNA STAT-60TM (Tel-Test).
Drug Research > Drug Discovery & Development > White Papers
1.14 Droplet UV/VIS Quantification of Native Proteins in Biopharmaceutical Processing
| By Trinean
Biopharmaceuticals are mainly produced by microbial fermentation or in animal cell cultures. As a consequence, a cascade of procedures including purification and characterization are required throughout the processing chain to obtain the protein at the desired level of purity and potency. Within these processes, quantification of the protein of interest is mandatory at critical steps to maintain confidence in the processing results and fidelity in the end product.
Drug Research > Drug Discovery & Development > White Papers
1.17 Maxwell®16 Blood purification Kit App and Maxwell®16 LEV Blood DNA Kit App
| By Trinean
A spectral content profiling application on the cDrop™ software is available for quantification and contamination analysis of DNA isolations from blood using the Maxwell® 16 Blood DNA purification Kit and The Maxwell®16 LEV Blood DNA Kit. In this note we describe how to use this application and how to export and interpret the results.
Drug Research > Drug Discovery & Development > White Papers
1.19 Qiagen® EZ1 Tissue DNA app
| By Trinean
A spectral content profiling application on the cDrop™ software is available for quantification and contamination analysis of DNA isolations from cells using the Qiagen® EZ1 Tissue DNA kit. In this note we describe how to use this application and how to export and interpret the results.
Drug Research > Drug Discovery & Development > White Papers
1.2 DropSense96 and its DropPlates, a Versatile Tool for Nucleic Acid and Protein Droplet Quantification
| By Trinean
As the demand for molecular tests increases, automated systems for biomolecule isolation and sample analysis are becoming popular. These facilitate integration of the complete molecular test in a full automatic set-up with liquid robots and bar-coded sample tracking resulting in a significant higher throughput while minimizing tedious manual repetitive tasks. The Trinean technology is a unique combination of the DropSense96 droplet plate reader, the 96well DropPlate microfuidic consumables and the DropQuant analytical software enabling direct quantification of small biomolecule samples in these high throughput, automated workflow.
Drug Research > Drug Discovery & Development > White Papers
1.20 Quantification of His-tagged IgG antibodies after IMAC Ni-column purification
| By Trinean
Trinean introduces a new cDrop™ application suited for the quantification (OD280) of IgG antibodies and derivatives like Fab fragments during purification by IMAC Ni-columns using imidazole-containing buffers.
Drug Research > Drug Discovery & Development > White Papers
1.3 Micro-volume Protein Quantification using the DropSense96 Droplet Plate Reader
| By Trinean
The measurement of protein concentration in aqueous samples is an important assay in biochemistry research and protein production facilities. Spectrophotometric protein quantification assays are commonly used methods to rapidly determine the concentration of a protein. They utilize the direct UV absorbance of the protein at 280nm in combination with its extinction coefficient or an indirect dye-based methods like BCA, Lowry and Bradford assays.
Drug Research > Drug Discovery & Development > White Papers
1.5 Specific dsDNA Quantification UV/VIS-based cDrop™ Method vs Picogreen® Fluorescent Assay
| By Trinean
Precise quantification and normalization of isolated genomic DNA is critical for advanced molecular testing in life science research and molecular diagnostics. UV-Vis based quantification has long been the method of choice, mainly because of its convenience. However, determining the DNA concentration based on the absorbance at 260nm suffers from interference of components such as RNA, proteins and phenols. Alternative methods, such as the PicoGreen® based Quant-iT™ assay, based on fluorescence enhancement upon binding with dsDNA have been developed to address this issue.
Drug Research > Drug Discovery & Development > White Papers
1.7 Quantifying Amplicons in Non-Purified PCR Reactions: Direct Assessment of Product Yield
| By Trinean
The polymerase chain reaction (PCR) is a fundamental tool in molecular biology and clinical testing. Most genetic tests rely upon the power of PCR to enrich specific target-sequences prior to analysis. Analytical methods like sequencing are relatively expensive and labs want to minimize the resources spent on samples that don't meet the requirements of concentration and quality to deliver a reliable result.
Drug Research > Drug Discovery & Development > White Papers
10th Middle East Regulatory Conference (MERC) 2013. Collaboration, Partnership and Interaction: Authority and Industry
| By Drug Information Association
This is the 10th DIA Middle East Regulatory Conference in partnership with the Middle East Regulatory Network (MERN). The MERN is an ad hoc regional network of the EFPIA (European Federation of Pharmaceutical Industries and Associations). The MERN works in partnership with regulatory authorities and the pharmaceutical industry in the Middle East to develop legislation and regulatory practices that enable patients to have access to good quality medicines, including innovative medicines.
Regulatory Affairs > White Papers
12 Key Considerations When Purchasing a Rheometer
| By Malvern Instruments
This whitepaper outlines the 12 key considerations when purchasing a Rheometer.
White Papers
14th DIA Conference on European Electronic Document Management (eDM) 20–22 November 2013 Dublin, Ireland
| By Drug Information Association
During the middle ages alchemists were looking for the Philosopher’s Stone. As it was believed, the mythical substance could not only turn lead into gold, but also prolong life and restore youth. Although the goal was never achieved, alchemy paved the way to scientific methods and so to the medical advances of today. This has transformed our lives in more than one way.
Regulatory Affairs > White Papers
26th Annual EuroMeeting Vienna 2014, 25th - 27th March 2014 ACV, Vienna, Austria
| By Drug Information Association
The Annual EuroMeeting is DIA’s largest conference in Europe, attracting more than 3,000 professionals from industry, government, academia, as well as patient groups and students. It is unique in the quality of its content and speakers, and in the opportunity to network with like minded professionals, regulators and thought leaders. Early-bird rate for DIA Members – register by Tuesday, 11 February 2014 and save €185! Register onsite at DIA 2013 to save an additional €100!
Regulatory Affairs > White Papers
505(b)(2) Services
| By inVentiv Health
Extending the life of a therapeutic can substantially enhance its value. The 505(b)(2) approval route was designed to encourage innovation, extend the life of a product, and provide an opportunity for market exclusivity, while minimizing the time and cost required for traditional clinical studies. For some products, the reference drugs can be relied upon for the safety and efficacy information (non-clinical and clinical), with some additional work required to establish comparability.
White Papers
7th Annual DIA Clinical Forum Dublin, Ireland on 8–9 October 2013.
| By Drug Information Association
The DIA Clinical Forum is known as a conference that brings together experts from different fields, including data management, clinical operations, drug safety, medical affairs, medical information and medical writing. Experts share their expertise and experience with people from other companies and disciplines. Making the presentations and workshops relevant to the day to day work of participants has always been the focus of previous programme committees – and I am glad to confirm that this won’t be any different this year.
Regulatory Affairs > White Papers
7th DIA/EFGCP/EMA Medicines for Children Conference, 24th-25th September 2013, London, UK
| By Drug Information Association
This year’s DIA/EFGCP/EMA paediatric conference will take place in the seventh year of the EU Paediatric Regulation. Over 1’000 Paediatric Investigation Plans (PIPs) have been submitted so far and paediatric aspects are now an integrated part of drug development.
Regulatory Affairs > White Papers
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