Navigation Links
Manufacturing process developed for HIV microbicide
Date:7/3/2014

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
ktedrow2@unl.edu
402-472-1962
University of Nebraska-Lincoln
Source:Eurekalert

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:
*Name:
*Comment:
*Email:
(Date:4/14/2016)... TEL AVIV, Israel , April 14, 2016 /PRNewswire/ ... in Behavioral Authentication and Malware Detection, today announced the ... has already assumed the new role. Goldwerger,s ... for BioCatch, on the heels of the deployment of ... In addition, BioCatch,s behavioral biometric technology, which discerns unique ...
(Date:3/31/2016)... , March 31, 2016  Genomics firm Nabsys has ... CEO, Barrett Bready , M.D., who returned to ... the original technical leadership team, including Chief Technology Officer, ... Product Development, Steve Nurnberg and Vice President of Software ... the company. Dr. Bready served as CEO ...
(Date:3/22/2016)... India , March 22, 2016 /PRNewswire/ ... market research report "Electronic Sensors Market for Consumer ... Proximity, & Others), Application (Communication & IT, ... Geography - Global Forecast to 2022", published ... industry is expected to reach USD 26.76 ...
Breaking Biology News(10 mins):
(Date:6/27/2016)... ... 2016 , ... Newly created 4Sight Medical Solutions ... healthcare market. The company's primary focus is on new product introductions, to include ... are necessary to help companies efficiently bring their products to market. , The ...
(Date:6/27/2016)... , June 27, 2016  Liquid Biotech ... the funding of a Sponsored Research Agreement with ... tumor cells (CTCs) from cancer patients.  The funding ... CTC levels correlate with clinical outcomes in cancer ... data will then be employed to support the ...
(Date:6/24/2016)...  Regular discussions on a range of subjects including policies, ... entities said Poloz. Speaking at a lecture to ... he pointed to the country,s inflation target, which is set ... "In certain areas there needs ... economic goals, why not sit down and address strategy together?" ...
(Date:6/24/2016)... Brooklyn, NY (PRWEB) , ... June 24, 2016 , ... ... 15mm, machines such as the Cary 5000 and the 6000i models are higher end ... height is the height of the spectrophotometer’s light beam from the bottom of the ...
Breaking Biology Technology: