We are a gene therapy company for developing safe gene medicines and potent transfection reagents.
HPAEs platform technology
Toward Next Generation of High-Performance Non-Viral Gene Delivery Vectors
Our new website is under construction. Any inquries please contact [email protected]. Thanks for your understanding!
Our new address: Lab 4, Building 10, cherrywood Business Park, Cherrywood, Loughlinstown, Co. Dublin, lreland, D18 T3Y1
News
Branca Bunús gained Type II DMF ID from FDA for its BrPERfect transfection reagent!
Branca Bunús has reached another milestone with successful submission of a Drug Master File (DMF) to FDA, for its lead product, HPAE polymer-based transfection reagent. We were pleased to receive the certificate confirming Branca Bunús Ltd as a DMF holder (DMF number 39924) from June 2024.
For Biotech and pharmaceutical companies, submitting a DMF to FDA is an important step that demonstrates commitment to quality and will facilitate regulatory approval and compliance. DMFs provide details on how a substance is manufactured and processed to confirm that it meets strict regulatory standards. Various types of DMFs are in use, in this case Type II which is relevant for pharmaceutical manufacturing.
Good news from Branca Bunús Ltd!
We have achieved certification from the National Standards Authority of Ireland (NSAI) that our Quality Management System meets the requirements of international standard ISO 9001:2015.
“Gaining the NSAI certification is a significant achievement of the company as we regard our global customers as the centre of our business and our core mission is to provide high quality products and services to our customers.”
Dr Hongyun Tai, Managing Director and CEO
IS0 9001:2015 is the international standard for the most recognised quality management system worldwide and sets out standardised requirements across a wide range of industries. The QMS maintained in Branca Bunús covers the company’s processes, procedures, and responsibilities in developing and manufacturing our products including gene transfection reagent BrPERfect series. The benefits of implementing this QMS allow Branca Bunús to establish confidence in ensuring compliance with regulatory requirements and with the key focus of meeting customer needs for the quality of the products and services.