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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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Nemera launches UniSpray, its unidose system primarily for systemic-acting drug administration
Nemera has a proven track record in developing and manufacturing complex
Ear Nose and Throat solutions. In line with clear growing market
interest in unidose system coupled with promising advantages that nasal
route could offer, Nemera is thrilled to extend its portfolio by
launching its unidose system, UniSpray, for systemic-acting drug
administration to face emergency and crisis.
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White Papers |
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The Role of the CRO in Effective Risk-Based Monitoring
Medpace
The clinical trial industry is evolving. In an effort to improve participant safety and data integrity, regulators are encouraging trial sponsors to transition from a focused on-site monitoring approach they have traditionally employed toward a risk-based approach that utilizes a combination of centralized and on-site monitoring techniques to ensure patient safety and data quality. The Risk-Based Monitoring (RBM) paradigm has many potential advantages over established monitoring practices including enhanced patient safety and data integrity, more efficient and effective protocol design, reduced costs, and the ability to strategically adjust oversight in keeping with changes in risk level.
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