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Pharma Horizons: leading-edge formulation
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
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Articles
LC-MS In-Depth Focus 2015
In this free-to-view LC-MS in-depth focus, we delve into the world of glycans, and how their natural complexity necessitates sophisticated sequencing techniques, while another article aims to demonstrate the versatility of LC-MS and the ease with which it can be combined with a variety of MS systems, focusing particularly on…
Precompetitive collaborations in the pharmaceutical industry
20 April 2015 | By Dave Elder, GlaxoSmithKline and JPAG
Increasing research and development costs, low productivity, reduced product life cycles, governmental pricing containment, convergence of technologies and increasing regulatory oversight are challenges that increasingly provoke pharmaceutical companies into making precompetitive collaborations with other organisations.
Outsourcing in the analytical and microbiology area
20 April 2015 | By Roger A. Stroud, R Stroud Pharmaceutical Quality Solutions Limited
Increasing numbers of pharmaceutical companies are considering outsourcing in the area of analytical and microbiological testing, from the very smallest start-up, virtual, or small company up to the largest multinational. This article will examine the factors that lead to a company deciding to outsource, and provides invaluable guidance on the…
Drug pricing reforms: the Danish experience
20 April 2015 | By Ulrich Kaiser, University of Zurich / Susan Mendez, Melbourne Institute of Applied Economic and Social Research / Thomas Rønde, Copenhagen Business School / Hannes Ullrich, DIW Berlin and University of Zurich
Reference price systems for prescription drugs have found widespread use as cost containment tools. Under such regulatory regimes, patients co-pay a fraction of the difference between pharmacy retail price of the drug and a reference price. Reference prices are either externally (based on drug prices in other countries) or internally…
Reducing microbial contamination via sterile risk assessment
20 April 2015 | By Guenther Gapp, Lachman Consulting Ltd/Independent Consultant
Several years ago, microbiologist Guenther Gapp created a new sterile risk assessment tool (based on a hazard operability analysis [HAZOP] approach) to identify and reduce the microbial contamination and compliance risk of aseptically-produced sterile products and production plants. The following article describes the operating principle of three risk analysis tools…
Real-time biological particle counting in environmental monitoring
The methods for monitoring air in cleanroom environments: viable counting techniques (settle plates and biological air samplers) and particle counters, are long established technologies and have been widely used in pharmaceutical manufacturing environments for decades. Although innovations have taken place with both particle counters and biological air samplers, primarily in…
Manufacturing Solutions: Continuous processing
20 April 2015 | By Ivo Backx, Manager, Business & Project Development for the Pharmaceutical Industry, Siemens
Ivo Backx of Siemens discusses continuous processing in the context of the company’s Simatic PCS 7 system and PAT software...
The scope of PAT in real-time advanced control of tablet quality
20 April 2015 | By Ravendra Singh, Marianthi Ierapetritou and Rohit Ramachandran: Rutgers University
Continuous pharmaceutical manufacturing together with process analytical technology (PAT) provides a suitable platform for automatic feed-forward/feed-back (FF/FB) control of the end product quality as desired by quality by design (QbD)-based efficient manufacturing. The precise control of the quality of the pharmaceutical product requires proactive, corrective actions on the process/raw material…
HPLC: On-chip liquid chromatographic separation
High-performance liquid chromatography (HPLC) is a powerful separation technique due to its high accuracy, precision, versatility and robustness. In the development of pharmaceuticals, it is no doubt that LC is a key technology in the quality control of pharmaceuticals and pharmacokinetic studies and in the analysis of complex biological compounds…
Issue #1 2015 – Digital edition
In Issue #1 2015: Regulatory Insight, Biologics, NIR in-depth focus, Raman in-depth focus, PAT, Drug Delivery, Microbiology Series and much more...
The cost of drug counterfeiting
The World Health Organisation (WHO) in 2010 described counterfeit medicines as those which are “Deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active…
Turkey: A rising star in the pharmaceutical industry
10 March 2015 | By Özge Atılgan Karakulak and Zeynep Koray, Gün + Partners
You are waiting in line, trying to decipher several different languages spoken around you: English, Dutch, German, Arabic, French… This scene is not from an airport but rather from a Turkish hospital: thousands of foreigners, communicating through translators, visit healthcare institutions every day and numbers are increasing exponentially; in the…
TandAbs: potent and well-manufacturable bi-specific antibodies for immunooncology
10 March 2015 | By Michael Weichel, Kristina Ellwanger, Ivica Fucek, Stefan H.J. Knackmuss, Erich Rajkovic, Uwe Reusch, Claudia Wall, and Eugene A. Zhukovsky, Affimed Therapeutics AG
The bi-specific antibody format is becoming the preferred antibody modality for current development projects in the pharmaceutical industry. This is due to an unsurpassed increase in functional activity relative to traditional mono-specific monoclonal antibodies, and a breakthrough in manufacturability enabled by novel designs. One such bi-specific format, the TandAb, produces…
Continued process verification – a challenge for the pharmaceutical industry?
10 March 2015 | By Michael Rommerskirchen, Boehringer Ingelheim
Nowadays, professional quality and process data trending is key for science-based pharmaceutical development and manufacturing. Recently, the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) issued revised process validation guidance to enforce recurring data analysis as a regulatory core requirement1,2: Periodic product and process monitoring, also known…
Evaluating inhaler performance using idealised throats
10 March 2015 | By Andrew R. Martin and Warren H. Finlay, University of Alberta
The development of orally-inhaled drug products is a complex endeavour spanning multiple technical and medical fields. For the treatment of respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD), the inhalation delivery route permits the drug to be directly targeted to the afflicted organ, namely the lung. As…
