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Of Paramount Importance

Parenterals are an important segment within the drug delivery field, assuming approximately 30% of the market share. One factor driving this is the substantial emergence of new therapeutic antibodies and advancements in biotechnology, resulting in many improved medications that have led to enhancements in patient wellbeing and life expectancy (1,2).

The realisation and proliferation of recombinant DNA technology led to the development of protein drugs. In particular, the development of monoclonal antibodies (mAbs) as drugs has increased significantly over the past few years. From 2014 onwards, 64 mAbs have been approved, are pending or are in review in Europe and the US. Additionally, more than 200 are in a clinical study stage. As explained by Dr Steven J Shire, mAbs are very specific, binding to a single antigen target, which may lead to fewer side effects than small molecule drugs (3).

Product Control


Biopharmaceuticals are frequently administered through injection using pre-filled syringes (PFSs); however, proteins are inherently unstable, sensitive to heat and oxidisation and have the propensity to aggregate (4-6). This generates the need to control the stability and quality of the drug product (DP), mitigating possible interactions in a risk-based approach for preventing effects on drug efficacy, pharmacokinetics and clinical consequences affecting patient safety.

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William Dierick is Director of Technology Development Global Pharmaceutical Solutions at Terumo: a global R&D company that offers drug delivery devices and injection technology, cardiology and cardiovascular systems, transfusion, patient monitoring and clinical systems. With 40 years of experience in the medical and pharma sector, he has held various positions in the company, covering quality assurance, production and product development to marketing, corporate planning and business development. William serves as expert of ISO/TC76 and ISO/TC84 and is an active member of MedTech Europe and volunteer at PDA.

Dr Piet Christiaens is Scientific Director at Toxikon Europe where he develops analytical methods and protocols for E&L studies for the medical and pharma industries. He oversees all laboratory operations at the company and is supporting the European business development. Piet received his PhD from the Analytical Chemistry Department of the University of Leuven, Belgium, in 1991. 

Dr Wim Van Rossom graduated with an MSc in organic chemistry in 2006 and received his PhD in 2010 from the Catholic University of Leuven, Belgium. In 2011, he moved to Japan where he spent two years as a Postdoctoral Fellow at the National Institute for Materials Science designing synthetic approaches towards macrocyclic structures. He was selected by the European Commission for a Marie Curie Career Integration Grant in 2013 to continue his research at the University of Southampton, UK, as Research Fellow on the topics of supramolecular anion recognition and transmembrane anion transport. Since 2015, he has been Study Director at Toxikon Europe, focusing on E&L studies in parenteral applications. 
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William Dierick
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Dr Piet Christiaens
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Dr Wim Van Rossom
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Pharmacovigilance and Risk Management Information in Centralised Applications in the EU

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Getting a new medication approved for the EU market through the centralised procedure can be complex and needs expertise. The new EU pharmacovigilance legislation (Good Vigilance Practice, GVP) is now in effect and applicants need to be fully compliant. It is critical to have a thorough understanding of the regulatory process and requirements, and the expectations with regards to the pharmacovigilance system and the risk management plan. Ensuring consistency and an appropriate level of detail in the documentation submitted as part of the approval process will help prevent unnecessary delays.
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ASPIRE: International EDGE Conference

28 February - 1 March 2018, The Vox Conference Centre, Birmingham

The ASPIRE international conference is taking place on the 28th February and 1st March 2018 at the Vox Conference Centre in Birmingham. The conference brings together members of the research community including research professionals from the NHS, Clinical Trial Networks and international organisations. The ASPIRE conference will allow delegates to share knowledge and best practise with the focus on enhancing the efficiency and productivity of clinical research across the UK and beyond.
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