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
Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. Papers will be published continuously (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.
Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are refereed through a peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Bioengineering is an international peer-reviewed Open Access quarterly journal published by MDPI.
Please visit the Instructions for Authors page before submitting a manuscript. For the first couple of issues the Article Processing Charge (APC) will be waived for well-prepared manuscripts. English correction and/or formatting fees of 250 CHF (Swiss Francs) will be charged in certain cases for those articles accepted for publication that require extensive additional formatting and/or English corrections.
- 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