Manufacturing issues force delay for PolarityTE's skin repair hopeful | FiercePharma

PolarityTE’s skin repair hopeful has run into an FDA setback over chemistry, manufacturing and control issues. (PolarityTE) Manufacturing issues are common with regenerative medicines. And so it goes for PolarityTE’s investigational new drug submission for SkinTE. On Tuesday the Salt Lake Salt Lake City biotech revealed that it has put its investigational new drug (IND) application on hold in chronic cutaneous ulcers to address chemistry, manufacturing and control (CMC) issues raised by the agency. The FDA wants a more clear idea of the cellular makeup of SkinTE and how that relates to the product’s effectiveness, Richard Hague, president and COO of Polarity said in an interview. The company has submitted data to the FDA to address those concerns, he added. On its website, PolarityTE describes SkinTE as “donated human tissue for autologous, single application use only.” The company manufactures the product from a patient’s own tissue, using the “patient’s own body to support the regenerative process,” the biotech says. The FDA will explain the action further when it issues a clinical hold letter to the company by Sept. 21. PolarityTE submitted its application on July 23. RELATED: PolarityTE rolls out skin-regeneration platform  Despite the FDA setback, PolarityTE still sees a big opportunity…
Read More