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European Biopharmaceutical Review

Fighting the Global Threat

The discovery of penicillin by Alexander Fleming in 1928 revolutionised medicine. This antibiotic soon became one of the most widely used in treating common bacterial infections, as well as pneumonia, tuberculosis, syphilis, and more (1). However, the Nobel Prize winner also predicted how an irresponsible use of penicillin could lead to the development of resistant bacteria, resulting in losing the antibiotic efficacy and death caused by a lack of alternative treatments. His concern has become a real-life scenario, affecting the medical sector and animal husbandry on a global scale.

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Adrian Fellows has been involved in R&D − particularly in the fields of disinfection and infection control − since 1972. He has filed numerous successful patents in these areas and others, including thermal devices and chemical specialities. Adrian filed the first patent applications for disinfectant wipes in the early 1970s, led a multinational team in an EU framework R&D program, and was a visiting research fellow at Huddersfield University, UK. Since 2005, he has been R&D director for Gama Healthcare, which has become a leading presence in global infection control. More recently, Adrian has been involved in leading collaborative projects in developing novel means to combat AMR.
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Adrian Fellows
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News and Press Releases

Northway Biotechpharma Celebrates 15 Years of Growth and Success

Vilnius, Lithuania, July 16, 2019 ─ Northway Biotechpharma, a leading biopharmaceutical contract development and manufacturing organization (CDMO), celebrates its 15th anniversary today. As a midsized CDMO, Northway Biotechpharma is able to provide flexibility and responsiveness backed by a strong foundation in science and technology. The company focuses on understanding its customers and meeting their specific needs without binding them to one single approach. It is able to react rapidly to unexpected project changes, adjusting timelines, capacities and other activities to meet its customers’ evolving needs. On average, Northway Biotechpharma has 25–30 development projects underway each year, ranging from gene cloning to final drug product manufacturing.
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Extractables and Leachables Testing: A Risk Based Approach

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Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime. Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance. Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure. This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
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2020 Avoca Quality and Innovation Summit

3-4 June 2020, Amsterdam, The Netherlands

The 2020 Avoca Quality and Innovation Summit will take place 3-4 June 2020, in Amsterdam, The Netherlands.
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