What We Do
BioFlex Solutions – a Repligen company – offers expert design and custom manufacturing of single-use bioprocessing products. We provide a comprehensive range of products, including bioprocessing bags, bottles, and tubing assemblies. All manufacturing is done in our new state-of-the-art ISO Class 7 certified cleanroom, located in San José. We offer fully custom-tailored solutions for your bioprocessing needs, supported by a design team with over 35 years of experience to help bring your vision to life.
Quality Management System
At BioFlex Solutions, 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 ISO 9001:2015 certified, our quality system also incorporates many aspects of ISO 13485:2016 and cGMP standards. Our products are manufactured in an ISO Class 7 certified cleanroom, ensuring the highest level of control. At BioFlex Solutions, we strive to pass the most stringent evaluations – our customer’s audits. Our systems have met the demanding requirements of leading biopharmaceutical manufacturers, and we welcome the opportunity for you to review our qualifications with your team.
Bags
BioFlex Solutions offers expert design and custom manufacturing of single-use bioprocessing products. We provide a comprehensive range of solutions that include bioprocessing bags, bottles, and tubing assemblies. All manufacturing is performed in our state-of-the-art ISO Class 7 certified cleanroom, located in San José. We deliver fully custom-tailored products to meet your bioprocessing requirements, supported by a design team with over 35 years of experience dedicated to turning your ideas into reality.
Bottles
BioFlex offers bottle assemblies made with industry standard Nalgene bottles with overmolded cap assemblies. A variety of sizes from 60mL – 20L are available. Bottles can be integrated with sampling assemblies, bag manifolds, filter sets or any other tubing assembly. Customization is our specialty. Please contact us to share your bottle challenges.
BioFlex 2D MediaBags
BioFlex™ bags are advanced single-use liquid-handling systems engineered for biotech and pharmaceutical applications. They replace traditional rigid-walled plastic and glass tubes, flasks, bottles, and carboys with modern disposable bioprocessing bags. Using single-use bags minimizes cross-contamination risk, reduces cleaning and validation costs, and shortens overall process turnaround time.
BioFlex™ bags are manufactured in an ISO Class 7 cleanroom using FLEXCLR BPM multilayer film, featuring an inert mLLDPE product-contact layer and an EVOH gas-barrier layer to ensure excellent compatibility with sensitive biological processes. All materials exceed USP Class VI plastics testing requirements.
Designed to be fully self-draining, BioFlex™ bioprocessing bags allow smooth dispensing without dip tubes. Their optimized geometry eliminates air entrapment and prevents foaming, ensuring consistent, reliable performance.
BioFlex™ 2D MediaBags are suitable for storage and processing of a wide range of liquids, including media, buffers, process intermediates, and biological products. All materials are manufactured in the U.S.A. and gamma-irradiated at 25–40 kGy for sterility assurance.
FlexBottle assemblies use industry leading components and tubing
Starting with Cellon, Nalgene or our standard PETG bottles, we add our fully molded stopper assembly with weldable C-Flex 374, AdvantaFlex or Flexelene TPE in 2 and 3 port designs for media and buffer additions. Assemblies are available for bottle sizes 125ml, 250ml, 500ml, 1000ml, 2L, 4L, 5L in PETG, PC and HDPE bottle materials, providing biocompatibility and chemical compatibility for a wide variety of bioprocess applications. As with our other products, we can customize our FlexBottle assemblies to meet most application requirements. All assemblies are Gamma Irradiated at 25-40 kGy.
The Science Behind Our Innovations
Our biotech solutions are designed to help you achieve your research goals. Explore our platform and see how we can help you.
Patient-centered care – we put the needs of our pOur biotech solutions are designed to help you achieve your research goals. Explore our platform and see how we can help you.atients first in everything we do.
