Navigation Links
Manufacturing process developed for HIV microbicide

Lincoln, Neb., July 3, 2014 Scientists at the University of Nebraska-Lincoln College of Engineering's Biological Process Development Facility have successfully produced a drug compound with potential to block HIV transmission in women.

The compound features the 5P12-Rantes molecule, discovered by scientists at the Mintaka Foundation in Switzerland to block HIV transmission by preventing the virus from attaching to human cells. Mintaka has contracted with the UNL facility to develop the manufacturing method for the compound.

The UNL facility has delivered its first batch of the compound to the non-profit research organization for formulation as a vaginal cream for use in clinical trials in South America. The facility landed the $3.8 million contract in 2010 from Mintaka to develop this biological production process for the microbicide.

The successful production run also confirms that the manufacturing process developed at the BPDF is ready to be transferred to a large-scale manufacturing facility, said Scott Johnson, Good Manufacturing Practices coordinator for the UNL facility.

Robin Offord, Mintaka's executive director, said his organization is "happy with the robust nature of the process developed at BPDF."

"Properly validated GMP production is key to Mintaka's plans to empower women and girls in developing countries with a means of protection from HIV/AIDS," he said. "Already, we have successfully transferred the technology to our collaborating institution in South Africa with excellent pilot scale results."

The BPDF's role in this phase of development illustrates the complexity of bringing drugs to clinical trial, officials said.

Good Manufacturing Practices are the strict guidelines imposed by the Food and Drug Administration for the development and manufacture of all pharmaceuticals, with rigorous procedures to test and validate every aspect of the development and production process.

UNL's BPDF meets those requirements, following strict quality control standards and scrutiny for the pharmaceutical industry, including long-term environmental and water quality testing. Johnson said the facility works closely with its clients to develop processes that will produce material suitable for use in clinical trials.

"A client will present us with a gene product they want expressed," he said. "We develop and optimize that process, then scale it up and move the finalized process to our GMP facility for production."

The successful production of 5P12-Rantes was the first to be completed in the BPDF's recently commissioned GMP plant in Othmer Hall. The GMP plant was the first in the nation to be established on a university campus.


Contact: Kimberly Tedrow, BPDF media contact
University of Nebraska-Lincoln

Related biology news :

1. Solar panel manufacturing is greener in Europe than China, study says
2. Major breakthrough in stem cell manufacturing technology
3. 3-D Printing and Additive Manufacturing: Preview issue of groundbreaking peer-reviewed journal now available
4. 3D Printing and Additive Manufacturing
5. Manufacturing a new gut to treat GI diseases
6. New technique controls dimensions of gold nanorods while manufacturing on a large scale
7. Training the future biomanufacturing workforce
8. Nanosensors could aid drug manufacturing
9. 3-D Printing and Additive Manufacturing preview issue publishing Fall 2013
10. Althea Technologies & Profectus BioSciences Sign Manufacturing Agreement For Plasmid DNA Production
11. Manufacturing crack-resistant lightweight components
Post Your Comments:
(Date:11/12/2015)... Nov. 12, 2015  Arxspan has entered into ... and Harvard for use of its ArxLab cloud-based ... tools. The partnership will support the institute,s efforts ... chemical research information internally and with external collaborators. ... for managing the Institute,s electronic laboratory notebook, compound ...
(Date:11/11/2015)...   MedNet Solutions , an innovative SaaS-based eClinical technology ... pleased to announce that it will be a Sponsor of ... to be held November 17-19 in Hamburg ... of iMedNet , MedNet,s easy-to-use, proven and ... has been able to deliver time and cost savings of ...
(Date:11/10/2015)... NEW YORK , Nov. 10, 2015 /PRNewswire/ ... refers to behavioral biometrics that helps to identify ... prevent fraud. Signature is considered as the secure ... for the identification of a particular individual because ... offers more accurate results especially when dynamic signature ...
Breaking Biology News(10 mins):
(Date:11/24/2015)... --> --> ... Synthesis Market by Product & Services (Primer, Probe, Custom ... RNAi), End-User (Research, Pharmaceutical & Biotech, Diagnostic Labs) - ... is expected to reach USD 1,918.6 Million by 2020 ... of 10.1% during the forecast period. Browse ...
(Date:11/24/2015)... Massachusetts , November 24, 2015 SHPG ... will participate in the Piper Jaffray 27 th Annual Healthcare ... Tuesday, December 1, 2015, at 8:30 a.m. EST (1:30 p.m. GMT). ... , Chief Financial Officer, will participate in the Piper Jaffray 27 ... , NY on Tuesday, December 1, 2015, at 8:30 a.m. ...
(Date:11/24/2015)... CITY , Nov. 24, 2015 /PRNewswire/ - ... "Company") announced today that the remaining 11,000 post-share ... Share Purchase Warrants (the "Series B Warrants") subject ... were exercised on November 23, 2015, which will ... Shares.  After giving effect to the issuance of ...
(Date:11/24/2015)... ... ... InSphero AG, the leading supplier of easy-to-use solutions for production, culture, and ... as Chief Operating Officer. , Having joined InSphero in November 2013 as ... promoted to Head of InSphero Diagnostics in 2014. There she has built up ...
Breaking Biology Technology: