Biotech and life sciences custom molder and designer PolyLinks Inc. is adding two Class 10,000 clean rooms that it expects will help the company double its annual sales during the next five years.
The first clean room, expected to be completed in the first quarter of 2012, will have nine all-electric presses that will largely be used to mold and assemble microfluidic types of products for the biotechnology industry, said Joe Malasky, president of the Asheville, N.C., company.
“We will be essentially adding all new presses,” ranging in clamping forces from 27-210 tons, Malasky said in a phone interview. He said the 5,000-square-foot clean room will be used to make genetic, diagnostic and cellular biology products for the biotech industry.
“We are expanding because we want more business,” said Malasky. “If you don't have the capacity, you can't go out and get more sales.”
Malasky said PolyLinks has been “more than doubling” sales during the last 15 years. However, he said sales for 2011 will be “a little less” than the company's $4.7 million in 2010. But he expects the firm's sales to rebound to $5.5 million next year and to $7 million by 2013.
“We hope in five years to be well over $10 million in revenues,” Malasky said.
Space has been set aside for the second clean room, which will be 4,500 square feet, and the equipment for that clean room will be added as new projects are started, and business grows, he said.
The clean room expansions are part of an overall $3 million expansion strategy that PolyLinks embarked upon in the summer of 2010 for its 45,000-square-foot complex.
The expansion and renovation of the building — about 75 percent complete at this point — will give the company a medical complex in Asheville that has clean room manufacturing, engineering and design, tooling and machining, clean room assembly and packaging, and a biotech startup business incubator that will have its own lab.
“We want our Asheville site to be a biotech development center that companies in the region can use as a business incubator for cutting-edge biotech devices,” Malasky said.
Last fall, for example, PolyLinks finished work on 8,000 square feet of space that will house the company's administrative and engineering staff. That portion of the complex also includes a conference area for hosting manufacturing forums, technology exchanges, and other meetings focused on boosting biotechnology business in the region.
“A lot of industries can't collaborate well enough and fast enough,” Malasky said. “We want to provide office space, developmental labs, and access to our manufacturing expertise for entrepreneurial-minded companies striving to bring innovative medical devices and biotech products to the market.”
“I always tell people we are not just a molder, not just a tool maker,” he said. “We do that, but in-depth. We can help you design, prototype it, validate it and do pilot production.”
“We are about helping you make a successful product, getting it validated and getting your initial run out there,” Malasky said “We are committed to making the customer successful.”
PolyLinks moved from a 5,000-square-foot building in nearby Arden to its existing facility in Asheville two years ago after renovating what previously had been a printing plant. “We took an old, dirty, dilapidated place filled with ink and now it looks like a hospital,” Malasky said.
PolyLinks' customers include Becton Dickinson, Illumina, Akonna Biosystems, Advanced Liquid Logic, Celula Inc., Applied Biosystems and Stovall Life Sciences.
For example, PolyLinks did the tooling development and the product manufacturability work for the BD AutoShield Duo. The BD AutoShield Duo is a pen needle, largely used in diabetes injections, that passively covers the front and back needles, eliminating exposure after use.
It also has helped to develop microfluidic devices that are part of diagnostic platforms and tools.
Two examples of those diagnostic tools: a medical device that looks like a lapel pen that determines the eye color of an unborn child, and another product — similar in appearance to a credit card — that contains a person's genetic makeup, and, when swiped, provides information on what medicines a person is taking and when they need to be taken.