* New manufacturing method uses tailor-made enzyme
* Approach will reduce the use of heavy metals
By Julie Steenhuysen
CHICAGO, June 17 (Reuters) - Merck & Co Inc (MRK.N) will soon be using a bio-engineered enzyme to make its diabetes drug Januvia in a greener approach to drug manufacturing that both improves yield and cuts cost, researchers said on Thursday.
The new method, detailed in the journal Science, replaces conventional chemistry with lab-produced enzymes engineered to have specific properties, said Skip Volante, vice president and global head of Process Research at Merck Research Labs.
“We’re creating an enzyme that can do a chemical reaction,” Volante said in a telephone interview.
The process will reduce the use of the heavy metal rhodium that Merck now uses to make the popular diabetes pill, known generically as sitagliptin, Volante said.
The work is the product of a collaboration between Merck and Codexis Inc (CDXS.O), who both have been nominated by the Environmental Protection Agency for the EPA Green Chemistry Challenge Award.
A team lead by Christopher Savile of Codexis used a “directed evolution” approach to evolve an enzyme to have more desirable properties.
“What we do is that we engineer the genes that carry the code for the enzyme of interest,” Savile said in an e-mail.
Then they screen the enzymes produced by these genes to see if the have the properties needed for a specific chemical reaction.
“Every organism in nature contains enzymes that perform the chemical reactions required to sustain life. We engineer such enzymes to function in a chemical plant,” Savile said.
Enzymes are greener catalysts than those currently used in manufacturing since they are organic and biodegradable, Volante said in a telephone interview.
The team started with a natural enzyme that contained the basic properties to do the chemical reaction needed to make Januvia, then genetically altered bacteria that make the enzyme to bring out characteristics needed for the chemical reaction.
The result was a so-called “bio-catalyst” that can can be used to replace a process that previously relied on rhodium to do the trick
“A big factor is we get a 10 to 13 percent increase in yield by doing this,” Volante said, and the process cuts waste by 19 percent over the existing manufacturing process.
Volante said the company still needs to get the process validated by regulators, but it plans to scale it up as soon as possible. (Reporting by Julie Steenhuysen, editing by Anthony Boadle)