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:4/28/2016)... April 28, 2016 First quarter 2016:   ... 966% compared with the first quarter of 2015 The ... 589.1 M (loss: 18.8) and the operating margin was 40% (-13) ... Cash flow from operations was SEK 249.9 M (21.2) ... guidance is unchanged, SEK 7,000-8,500 M. The operating margin ...
(Date:4/26/2016)... , April 27, 2016 ... the  "Global Multi-modal Biometrics Market 2016-2020"  report to ... ) , The analysts forecast the ... CAGR of 15.49% during the period 2016-2020.  ... number of sectors such as the healthcare, BFSI, ...
(Date:4/15/2016)... 15, 2016  A new partnership announced today ... underwriting decisions in a fraction of the time ... and high-value life insurance policies to consumers without ... With Force Diagnostics, rapid testing (A1C, Cotinine and ... (blood pressure, weight, pulse, BMI, and activity data) ...
Breaking Biology News(10 mins):
(Date:5/3/2016)... ... May 03, 2016 , ... In a list published by the Boston ... 76 fastest-growing private companies; a small percentage of the state's 615,000+ small businesses. The ... percent change in revenue from 2012 to 2015. , As this award ...
(Date:5/3/2016)... , May 3, 2016 ... Assessing Developers and Producers of Those Competitor Biologics  ... to Companies, Activities and Prospects ,  Who ... companies? And what are their sales potentials? Discover, ... you see results, trends, opportunities and revenue forecasting. ...
(Date:5/2/2016)... Willoughby, Ohio (PRWEB) , ... May 02, 2016 ... ... website. Designed with its clients in mind, the fresh look and added functionality ... capabilities. , “Recent years have seen a dynamic shift in agriculture – from ...
(Date:4/29/2016)... ... April 29, 2016 , ... Amendia, Inc., a ... procedures, today announced the completion of a significant transaction and partnership that positions ... customers and partners. Kohlberg & Company, L.L.C. (“Kohlberg”), a leading private equity ...
Breaking Biology Technology: