Automated Peptide Synthesizer Export Controls Wouldn’t Achieve BIS Goals, Companies Say

The Bureau of Industry and Security should avoid placing export controls on automated peptide synthesizers, U.S. companies said, arguing that the restrictions would hurt U.S. technological leadership and wouldn't do much to limit the proliferation of biological weapons. A Chinese national academy also opposed the controls, saying they could stifle global research and innovation.

BIS in September asked for feedback on whether it should propose controls on “certain instruments for the automated synthesis of peptides” because of their potential to be used to produce controlled toxins for biological weapons purposes (see 2209120021). But several American companies, in comments released this week, said those instruments aren’t necessarily required to create biological toxins as weapons.

“The end user can produce controlled toxins for biological weapons without this instrument manually,” said Gyros Protein Technologies, a global leader in peptide synthesis and bioanalytical technology. The technology is used only to speed up the process, the company said. “The automation of this process is only facilitating this in terms of speed. Peptides have been synthesized manually since the onset of peptide synthesis.”

U.S. export controls wouldn't “be effective in controlling the production of a peptide toxin,” said CEM, which develops laboratory instrumentation and scientific methods used by researchers and universities. CEM said a specific peptide toxin “would presumably still be able to be produced manually or with globally available simple automation” instrumentation, adding that the automated process would allow an end-user to improve “the synthesis quality for more difficult/complex peptides” and allow them to “be made at higher purity levels.”

But “a peptide toxin used for nefarious purposes would not necessarily need to be made in high purity levels required for research studies or GMP [good manufacturing practices] production levels for drug safety,” said Jonathan Collins, CEM’s vice president of business development. “I don’t think export controls on peptide synthesizers would prevent the potential production of peptide toxins.”

Controls could also hurt American technological leadership, said AmbioPharm, a U.S. pharmaceutical company. Major equipment suppliers “all sell their equipment around the world,” the company said, and any export restrictions would hurt U.S. firms’ ability to “maintain their market shares” in other countries.

“Those companies outside [the] USA are not only capable [of developing] the similar synthesizers and [taking] over the market share left by the US companies,” AmbioPharm said, “but also become the industrial leaders.”

The company also said BIS shouldn’t even look into multilateral controls. “It would not benefit humanity in general,” it said. “There are many companies in China and India who are competing for the peptide synthesis business but those companies in USA and Europe are the leaders due to their operation size and reputation.” New controls would “limit those companies in USA and Europe to [be able to] compete effectively, and those companies in China and India may compete more effectively and become the industrial leaders for peptide manufacturing in the world.”

But Gyros Protein Technologies said BIS should look into some type of multilateral control. The company said peptide synthesizer technology should remain an EAR99 technology -- a category in the Export Administration Regulations reserved for items that usually don’t require an export license -- but should be multilaterally controlled for certain military end-users and end-uses.

“This condition should be implemented as a multilateral agreement under the European Union, the United Nations and Asia Pacific export compliance regulations,” the company said. “With this multilateral agreement in place, the impact on the U.S. industry would be equivalent to its impact on the global competition while at the same time ensuring that the technology is used as intended.”

Academia Sinica, a Chinese national academy located in Taiwan, said automatic peptide synthesizers are an “indispensable instrument in research related to peptides and glycoproteins” and export controls could “considerably impact” academic research and “set back the development of biomedical technology.”

The academy also said “many” countries already impose controls on exports of toxic proteins. “Therefore, we support the existing regulations on the management of automatic chemical peptide synthesizers instead of creating new control regulations,” it said. “Automated chemical peptide synthesizers should not be subject to control, but rather be an instrument for improving the wellbeing of all mankind.”