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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...
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Issue 1 2015
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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…
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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…
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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…
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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…
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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…
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The role of water activity in the microbial stability of non-sterile pharmaceutical drug products
Aqueous, multiple-use, non-sterile drug products are susceptible to microbial contamination during their shelf life. To protect these products from this potential hazard to patients, they are formulated with antimicrobial preservatives. Other product attributes employed using the hurdle concept to prevent microbial contamination include: low pH, low redox potential, reduced storage…
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Near-Infrared Spectroscopy (NIR): In-Depth Focus 2015
This free-to-view NIR In-Depth Focus reveals the fascinating evolution and future perspectives of near-infrared technology in the lively opening article, plus we examine the benefits of combining NIR spectroscopy with process analytical technology...
