Nygene Corp. is trying to create breakthroughs in monoclonalantibody production that will enable it to become a key playerin the world market for antibody-based products, which itprojects will grow to $6 billion by the year 2000.
The Yonkers, N.Y., company's technology is designed to enablemajor increases in current MAb production volumes, and laythe foundation for high-speed selection of specific humanantibodies.
"We started out by identifying bottlenecks in the monoclonalantibody segment of the biotechnology industry because bydefinition, they hold back demand," said Frank Brunetta,president and chief executive officer. "The two we chose arebioseparation and hybridoma cell selection."
Separation of MAbs from tissue culture fluid or ascites fluid(fluid from a mouse's peritoneal cavity) accounts for 50 percentto 80 percent of the total cost of producing MAbs, according toNygene. Standard gel technology takes hours or days to achieve50 percent to 75 percent recovery levels at 98 percent purity.Nygene's membranes can reach 85 percent to 95 percentrecovery with the same degree of purity in five or 10 minutes,Brunetta said.
This core technology has potential diagnostic applications. Thecompany's first target is the mass blood screening market forAIDS and hepatitis. Nygene said it is collaborating with anundisclosed major blood center to test its membrane-basedassay for a combined AIDS/hepatitis test using known samples.If successful, Nygene will seek a corporate partner toexclusively distribute the assay.
Another potential diagnostic use is for rapid determination ofendotoxin-causED septic shock.
In the longer term, Nygene's clone selection technology, animmunoassay for both large and small molecules, should makepractical the development of human MAbs, instead of mouse orchimeric versions, Brunetta said.
According to the company, current methodologies are limitedby the low secretion rates of MAbs by cell lines and thedifficulty of selecting human clones secreting IgG.
Nygene said its single-cell selection technology can detect thesecretion of a target monoclonal antibody by single cells ofnatural or cloned human lymphocytes, using a laser to rapidlyscan microcultures. In three days, a specific cell can be selectedfrom among 10 million negative cells.
Nygene's strategy is to collaborate with corporate partners toselect human antibodies with average market potentials of$100 million and license the MAbs to those partners.
Nygene hopes to dip into the public offerings well for $20million, said Brunetta. The company has raised $14 millionfrom private investors since its founding in 1985. -- KarenBernstein
(c) 1997 American Health Consultants. All rights reserved.