FlexBiosys – a Repligen company – offers expert design and custom manufacturing of single-use bioprocessing products. We offer a comprehensive range of products that include bioprocessing bags, bottles, and tubing assemblies. All manufacturing is done in our new state-of-the-art ISO Class 7 certified cleanroom, located in Branchburg, NJ. We offer completely custom tailored solutions for your bioprocessing needs, and have a design team with over 35 years of experience to help you make your vision a reality.
At FlexBiosys, quality is built into our process. We operate a quality system that is ISO 9001:2015 certified and securely maintain full traceability of our manufactured goods. While we are ISO 9001:2015 certified, our quality system also maintains many aspects of ISO 13485:2016 and cGMP standards. Our products are manufactured in an ISO Class 7 certified cleanroom, to ensure an absolute level of control. At FlexBiosys we strive to pass the most stringent evaluations – our customer’s audits. Our systems have satisfied the most demanding requirements of biopharmaceutical manufacturers and we welcome the opportunity to you to review our qualifications with your team.