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PolyPid Announces Successful Commercial Good Manufacturing Practice (GMP) Audit by Israeli Ministry of Health
Successful Audit of the Company’s State-of-the-Art Manufacturing Facility Represents a Key Milestone Toward Plan to Commercialize D-PLEX₁₀₀ Globally PETACH
About this update from Polypid Ltd.
[{"type":"text","content":"Successful Audit of the Company’s State-of-the-Art Manufacturing Facility Represents a Key Milestone Toward Plan to Commercialize D-PLEX₁₀₀ Globally\nPETACH TIKVA, Israel, Sept. 21, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that the Israeli Ministry of Health has completed a successful Good Manufacturing Practice (GMP) audit of the Company's manufacturing facility without any critical or major findings. The audit was conducted as part of the Ministry of Health's routine evaluation of PolyPid’s manufacturing process for D-PLEX100. The audit concluded that PolyPid’s manufacturing facility, process and quality system conform to the requirements of current GMP for medicinal products. This audit is also valid for Europe under the provisions of the Agreement on Conformity Assessment and Acceptance of industrial products (ACAA) between the European Union and Israel. “We are pleased to achieve this important milestone which brings us one step closer to the potential commercialization of D-PLEX100 globally,” stated Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. “We can now produce D-PLEX100 at scale in order to fulfill the expected commercial demand for the product. This successful audit underscores the viability, quality and high standards that PolyPid upholds in the manufacturing of D-PLEX100 for clinical and commercial use in compliance with rigorous international standards.” About D-PLEX100 D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 i...