INITS selected Repligen’s KrosFlo® KR2i and KrosFlo® KMPi TFF Systems for its Biomanufacturing Facility

Montpellier, France – November 2025 — As part of the continued development of its Shared Manufacturing Organization (SMO), INITS is proud to announce the selection of two advanced Tangential Flow Filtration (TFF) systems from Repligen: The KrosFlo® KR2i and KrosFlo® KMPi TFF systems.

These cutting-edge systems will play a central role in enabling INITS’ clients to perform flexible, scalable, and GMP-compliant drug substance manufacturing — particularly in the field of cell and gene therapy.

• Three KrosFlo KR2i systems and one KrosFlo KMPi system will be installed in INITS’ 3,200 m² GMP facility in Montpellier.

• The KrosFlo KR2i TFF systems accommodate volumes ranging from 2 mL to 15 L, whereas the KrosFlo KMPi supports volumes between 100 mL and 500 L, facilitating efficient scale-up from lab-scale development to pilot-scale manufacturing.

• Repligen’s platforms provide flexible, automated process control with single-use technology, reducing validation time and minimizing cross-contamination risks.

  
  

Advanced TFF Solutions for End-to-End Bioprocessing

• KrosFlo® KR2i TFF system: This compact, automated TFF pump system is ideal for small-volume microfiltration and ultrafiltration processes up to 15 L, with recirculation volumes as low as 2 mL. It is compatible with flat-sheet cassettes and hollow fiber filters — making it an optimal choice for early-stage process development and scale-up.

• KrosFlo® KMPi TFF System: Designed for pilot-scale production, the KMPi system supports volumes from 0.1 L to 500 L. With a minimum recirculation volume of approximately 100 mL, this system enables highly reproducible scale-up while reducing fouling and maximizing recovery. Its single-use flow path design eliminates cleaning validation, shortens development timelines, and mitigates the risk of cross-contamination.

Together, these two systems will allow INITS to offer a seamless transition from lab-scale development to clinical manufacturing, all on one unified platform — maintaining consistent system architecture, software, and design throughout the lifecycle of production.

Solutions to Empower Biotech Innovators

The flexibility, automation, and scalability of the Repligen KrosFlo® systems are fully aligned with the INITS SMO model, where clients produce their own GMP batches under expert support for  Project Management, Training, Regulatory, Quality Assurance (QA), Quality Control (QC), and Supply operations.

“By integrating Repligen’s best-in-class filtration technologies into our SMO model, we can provide our clients with flexible and robust bioprocessing capabilities that evolve with their needs.” said Amel HADRI, CEO & Founder of INITS.

“We are delighted to support INITS in bringing their SMO concept to life,” adds Surendra BALEKAI, Vice President of Systems for Repligen. “Our KrosFlo® TFF systems are designed for flexibility and scalability, making them the perfect fit for organizations like INITS that aim to accelerate biomanufacturing while ensuring the highest standards of quality and compliance.”

About Repligen Corporation

Repligen Corporation is a global life sciences company that develops and commercializes highly innovative bioprocessing technologies and systems that enable efficiencies in the process of manufacturing biological drugs. We are “inspiring advances in bioprocessing” for the customers we serve; primarily biopharmaceutical drug developers and contract development and manufacturing organizations (CDMOs) worldwide. Our focus areas are Filtration and Fluid Management, Chromatography, Process Analytics and Proteins. Our corporate headquarters are located in Waltham, Massachusetts, and the majority of our manufacturing sites are in the U.S., with additional key sites in Estonia, France, Germany, Ireland, the Netherlands and Sweden. For more information, please visit www.repligen.com, and follow us on LinkedIn.

About INITS

INITS is an innovative service company dedicated to supporting biotech companies in their pharmaceutical development journey. Since 2013, INITS has supported more than 250 clients across Europe and internationally.

INITS operates through two divisions:

• INITS Consulting: INITS provide end-to-end support across all pharmaceutical development phases — in CMC, Regulatory strategy, Clinical supply, Quality Assurance, and Audits.

• INITS SMO: Currently in development and operational in Q2 2026, INITS SMO is a shared bioproduction facility that offers biotech companies a unique environment for Drug Substance manufacturing, with full support from INITS (Regulatory, QA, QC, Analytical, Supply Chain). For Drug Product manufacturing, INITS will act as a traditional CDMO, handling Fill & finish, Packaging, and product release operations

For more information about INITS, visit https://inits.fr.