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European Biopharmaceutical Review


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News and Press Releases

First cellularized collagen membrane implant to regenerate heart tissue in patients with ischemic heart disease

• 3P Biopharmaceuticals and Viscofan go ahead with this innovative project of regenerative medicine for cardiac use • Beginning of Phase I clinical trial in a group of 10 patients
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White Papers

Extractables and Leachables Testing: A Risk Based Approach

RSSL

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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Industry Events

CPhI Festival of Pharma

5-16 October 2020, Virtual

A virtual gathering for the pharmaceutical industry, the CPhI Festival of Pharma has been created to fill the gap left by in-person events at a time when travel and gatherings are off the cards.
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