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European Biopharmaceutical Review
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Proteins, proteins, proteins. They are a main feature in our spring edition of EBR –
perhaps not surprisingly, considering the continued increase in
adoption to clinical practice of high-value, high-performing protein
therapeutics and the need for their manufacture at scale by the
biopharmaceutical industry.
Rentschler Biotechnologie’s Dr Stefan R Schmidt and Dr Birgit Schwab
would argue that, considering the market size and recent numbers of US
and European approvals in these drug classes, the future for mid-size
contract development and manufacturing organisations lies in complex
proteins or ‘modern biopharmaceuticals’; monoclonal antibodies and
proteins for cancer and autoimmune conditions in particular (see full
pdf). In their articles, Christian Loch from AVMBioMed (see full pdf)
and Kim Plasman, Kris Gevaert, Francis Impens and Tony Montoye (see full
pdf) agree that, at present, proteomics is the best means for capturing
this vital information.
AVMBioMed highlight the need to consider the importance of
post-translational modification in defining the human protein
repertoire, and the Trinean team plus Kris Gavaert and Francis Impens
flag the need for further improvements in quality to move proteomics
towards a unified regulatory process.
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News and Press Releases |
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Avacta Announces FDA Approval of its Investigational New Drug (IND) Application for AVA6000
Cambridge and Wetherby, UK, 29 November 2021: Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer® and pre|CISION™ platforms, is pleased to announce that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for AVA6000. This will allow the Group to expand its Phase 1 clinical trial, ALS-6000-101, into clinical trial sites in the United States.
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White Papers |
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Detecting Integrity Breaches in a range of Pharmaceutical Blister Package Types using Sepha VisionScan
Sepha Limited
Demonstrating the integrity of pharmaceutical blister packs is critically important, as any defects can affect the shelf life and efficacy of the contents. Compared to bulk packaging, blister packs offer improved product integrity, tamper evidence and reduce the likelihood of misuse. Packs can be composed of either a thermoformed polymer or cold formed aluminium tray, with a number of individual pockets to hold the product. After the tablets or capsules are placed in the pockets, the packs are heat sealed with a paper or foil laminate sheet. These various stages can be completed separately or integrated into a single form, fill and seal process. There is a risk of microbial containment or degradation of the contents if any defects are present in the packaging. Such defects can take the form of rips or pinholes in the tray, or lid materials, faulty seals and channel leaks between pockets.
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