Monitoring contamination in continuous manufacturing of biologics

Interdisciplinary Areas: Engineering and Healthcare/Medicine/Biology

Project Description

Biologics are large complex molecules produced by microorganisms and mammalian cells. They are typically polypeptides or proteins such as monoclonal antibodies, cytokines, and fusion proteins. The sale of biologics in major pharmaceutical companies is expected to grow from 22% in 2013 to 32% in 2023. The manufacturing process for biologics is challenging and expensive because it needs to be closely monitored at multiple steps. One of the biggest hurdles in the manufacturing is the monitoring of contaminants such as aggregates, cell debris, bacteria, and viruses. 

This project will develop methods for monitoring bacterial contamination in continuous manufacturing of biologics (such as monoclonal antibodies). In addition, the project will also determine the appropriate response to the detection of such a contamination in the manufacturing process to minimize impact on the production.  

Start Date

July 2019

Postdoc Qualifications

Must have a PhD in one of the following or related fields: biological engineering, biomedical engineering, chemical engineering, microbiology, health sciences, industrial engineering, analytical chemistry. Must be interested in research in the field of biologics. Must demonstrate excellent communication skills, in the form of published papers and conference presentations. Prior experience with biosensors is desirable.  
 
Co-advisors
 
Mohit Verma
Assistant Professor
Birck Nanotechnology Center
Department of Agricultural and Biological Engineering
msverma@purdue.edu
www.vermalab.com
 
Arezoo Ardekani
Associate Professor
School of Mechanical Engineering
ardekani@purdue.edu 
https://web.ics.purdue.edu/~ardekani/ 
 
References
 

1. Gronemeyer, P., Ditz, R. & Strube, J. Trends in Upstream and Downstream Process Development for Antibody Manufacturing. Bioeng. Basel Switz. 1, 188–212 (2014).

2. Kelley, B. Industrialization of mAb production technology: the bioprocessing industry at a crossroads. mAbs 1, 443–452 (2009).

3. Yazdi, S.H., Ardekani, A.M. Bacterial aggregation and biofilm formation in a vortical flow. Biomicrofluidics, 6, 044114 (2012).

4. Verma, M. S., Chen, P. Z., Jones, L. & Gu, F. X. Branching and size of CTAB-coated gold nanostars control the colorimetric detection of bacteria. RSC Adv. 4, 10660–10668 (2014).

5. Verma, M. S. et al. Sliding-strip microfluidic device enables ELISA on paper. Biosens. Bioelectron. 99, 77–84 (2018).