Special Issue "Biopharmaceutical Process Development"
A special issue of Bioengineering (ISSN 2306-5354).
Deadline for manuscript submissions: closed (30 September 2014)
Prof. Dr. Christoph Herwig
Process development for the industrial production of biopharmaceutical drug substances is still time consuming. In addition, the process continues to have a high risk to fail at the manufacturing scale, due to high variability of biological origin and of the various input materials.
Not long ago, the regulatory bodies launched the Quality by Design (QbD) initiative, which proposes a systematic, science driven and risk based approach to process development. However, the current interpretation of QbD is mainly data driven, using statistical approaches, identifying correlations (“How” parameters and attributes are correlated), without emphasizing “Why”. Therefore, QbD is perceived to be laborious and does not reach the full potential of its intention.
The current special issue emphasizes scientific and risk based methods to accelerate bioprocess development while allowing a mechanistic approach for process understanding and safe scale up. As a consequence, it is reviving QbD also as a new business opportunity.
We look forward to receiving your contributions to these cutting edge issues.
Prof. Dr. Christoph Herwig
Manuscript Submission Information
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- integrated bioprocess development
- microbial and mammalian host organisms
- biopharmaceutical drugs
- upstream and downstream processing
- scale up, scale down models
- multivariate explorative analysis
- mechanistic modeling
- hybrid modeling
- bioprocess control