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March 3, 2008

BioTech Buzz: The Problem With Peptides

When people think about biotechnology, they most likely think of highly technical research or pharmaceuticals.

But there are an infinite number of businesses that spring up to serve the industry. One such niche business are peptide manufacturers. In Central Massachusetts alone there are several, including 21st Biochemicals in Marlborough and New England Peptide in Gardner.

But what exactly are peptides, and how does a company make money selling them? I asked Dave Robinson, CEO of New England Peptide, which has about 30 employees.

Peptides, which are proteins made up of fewer than 100 amino acids, are manufactured at New England Peptide using synthetic amino acids bonded to a small resin particle. Amino acids are added to the resin, along with chemicals to both encourage and discourage certain chemical reactions, in a predetermined “recipe,” according to Robinson.

At the end of the process, the peptides are separated from the resin and given a purity rating depending on the completeness of the amino acid bonds and the level of remnant catalytic chemicals in the peptide mixture. Purer peptides command a higher price, and take longer to make, Robinson said.

The process is fairly straightforward, as far as advanced biochemical manufacturing goes.

Peptide Disparities


Unfortunately, Robinson said, all peptides are not created equal, and there is some wiggle room for some manufacturers when applying all-important purity gradients to the end result.

 “The sad truth is that all peptides are not created equally,” Robinson said. “One company might use a different technique of purification and it might mask impurities. A scientist might assume something is of the right purity, and if it doesn’t achieve the desired result, he might move on. But had it been produced as purely as requested, it might have been exactly what they were looking for.”

The problem of uniform peptide quality is a growing one, Robinson said, as innovative new delivery methods are opening the doors for more peptide-based therapeutics.

New England Peptide supplies quality control information with every custom peptide it produces, in order to give scientists a traceable history of the compound’s production.

“There’s so much market pain around the issue,” of inconsistent peptide quality, Robinson said. “There’s not enough information out there to provide, in our opinion, the level of education required to help scientists. We spend a lot of time educating them what to look for.”

The company also does a rigorous quality control of all of its raw materials upon their receipt, Robinson said. It’s a part of the process where some other companies may cut corners in order to lower costs, but in the end “you get away from it what you put in,” Robinson said.

New England Peptide’s focus on product quality has gotten them noticed. The company has sold custom peptides to more than 1,000 customers in 30 countries since its founding in 1998.

The firm is now comfortably “middle-aged” as far as peptide manufacturers go, Robinson said, and their prosperity is a testament to the sustainability of their “quality first” business model.

Robinson said the company plans to stick around long enough to make it into old age. In order to meet those goals, the company will soon move beyond purely research-grade peptide production and move into commercial and clinical trials-grade peptides in the near future.

“In terms of opportunity as we see it, the biggest opportunity is in that market,” Robinson said. “We’ve been hearing it a lot from our customers, asking us to step in and fill that segment which is not being addressed as it should.”

Doing so will require FDA approval and some modifications and expansion at their 10,000-square-foot Gardner facility, or elsewhere, Robinson said. In order to meet the strict FDA-mandated manufacturing guidelines for commercial peptides, production will have to be set off from the research-grade materials.

Robinson said there is room to grow at the company’s Gardner facility, and plans to expand locally. He did not rule out expansion in other towns in the Worcester or Greater Boston area, however.

While declining to give a set timetable for expansion, or speculate on costs or sources of funding, Robinson said his company is currently taking steps to ensure a hasty entrance into the commercial peptide market.

“This is something we want to do prudently but aggressively,” he said. “We feel there’s an urgent need, and so we’re moving aggressively in that direction.”        

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