American Peptide set to finish expansion

VISTA — With the expansion of American Peptide’s manufacturing plant due to be completed this month, Vista is about to become an even stronger player in San Diego County’s biotech community.
Peptides are chains of amino acids with thousands of functions in nature. They thwart bacteria. They transport potassium in the bloodstream. They even give beef stew its unique taste.
Now that the human genome has been mapped, researchers can tailor peptides to combat cancer with unprecedented accuracy, and the peptide industry has boomed as a result. Ninety percent of American Peptide’s clients are developing drugs to fight cancer.
There are plenty of exotic applications as well, everything from topical hair growth to battling constipation. American Peptide has even synthesized a modified neurotoxin found in an obscure sea creature for use as an anesthetic during surgery.
American Peptide has been making peptides in Sunnyvale for 21 years. In 2002, the company opened a new facility in Vista solely for the purpose of making a higher end product for clinical trials.
“It actually works out really nicely with San Diego being the hub for a lot of customers,” Quality Control Director Scott Caton said. “There’s also a lot of fill/finish industries in the area so our customers can kill two birds with one stone.”
With peptides, a little goes a long way. American Peptide is one of the top five producers in the world and yet the Vista facility makes only 50 kilograms of product every year.
Until now, this has been sufficient, because the drug industry is something like a pyramid. At the bottom are the myriad businesses with an experimental pharmaceutical product. They test their drug in a series of clinical trials on larger and larger numbers of people. At each successive phase of testing, most of the drugs wash out for lack of performance or safety reasons. Few make it to Phase 3, the final clinical stage, and even fewer make it to market as a salable medication.
Phase 1 and 2 studies typically need peptides in 100-gram lots. Once a drug gets to Phase 3, however, kilogram-sized orders become common. With many of its customers reaching Phase 3 and beyond, American Peptide is expanding to fill the demand.
Besides being a peptide CMO, American Peptide Company offers value added
services such as process development, scale up production,analytical/ process validation, stability studies, CMC, DMF, and regulatory support. With offices in USA and presence in Japan, South Korea, England, APC is dedicated to delivering quality peptides to pharmaceutical and
biotech companies worldwide.
After construction is done, the expansion will have to go through regulatory scrutiny, but Shakoori said he expects that won’t produce much delay. American Peptide expects its new production suites to be online by May, quintupling production.
“In the news you hear about places closing doors and people losing their jobs,” Hu said. “For us, it’s the opposite.”

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