The DoD Medical Countermeasure Systems-Chemical Defense Pharmaceuticals (MCS-CDP) Joint Product Management Office has a requirement to develop and deliver FDA licensed butyrylcholinesterase (BChE).
BChE is a bioscavenger prophylactic countermeasure against organophosphate nerve agents, binding nerve agent in the bloodstream before it can exert effects in the nervous system.
DynPort Vaccine Company LLC, a CSC company, is the prime contractor for this effort.
On behalf of DVC, the MCS-CDP JPMO is seeking interest by research or commercial entities with the capability to perform process development activities at small scale to intermediate scale in order to identify a source raw material and process to fit to the commercial scale requirements of this DoD contract.
Source raw material and historical manufacturing information will be provided by DVC.
Capability requirements include:
- Acceptance of human plasma derived source material into the process development facility
- Storage of the source material at -80OC (up to 50kg of starting source material per run)
- Development and optimization of the purification process at the 1-5kg scale and 50kg scale
- Manufacture and testing of an interim Reference Standard (RS) to support process development and optimization activities
- Implementation of analytical methods to be used during process development and RS production effort, including but not limited to total protein, enzyme activity, and HPLC-based methods.
- Project Management support including status meetings and monthly reports with technical, schedule and cost elements
In addition, the selected contractor must be able to meet a November 2015 down select of source material and process for commercial scale manufacturing.
Further details are available via Solicitation Number: W911QY-15-S-DAMD17.
