The Biostat STR® Generation 3 with Biobrain® Automation Platform

Engineered for Ultimate Upstream Performance

Biostat STR^® single-use bioreactors and the Biobrain^® automation platform offer multiple configurations and convenient software upgrades to quickly adapt facilities as requirements change. The Generation 3 system is now available with integrated Repligen XCell ATF^® Technology for intensified processes and access to our best-in-class BioPAT^® toolbox. Biostat STR® bioreactors and Flexsafe STR^® bags range from 50 L to 2,000 L and can enhance speed, quality, and flexibility in process development and commercial manufacturing operations.

Biostat® B, the Universal Controller for Your Lab

The Biostat® B is our universal benchtop controller for stirred and rocking motion systems.

The multi-talented control tower opens up a new world of flexibility for your changing requirements. Use it as single or twin configuration, choose your cultivation chamber from our proven range of options:

• Conventional stirred-tank Univessel® Glass
• Single-use stirred-tank Univessel® SU

Biostat^® RM Bioreactor Powered by Biobrain^®

Engineered for Simplified Scale-Up

The Biostat^® RM is a GMP compliant, wave-mixing bioreactor. It is paired with single-use Flexsafe^® RM bags and is proven for a broad range of different cell lines incl. CHO, HEK293, stem cells, and CAR-T cells. Especially, customers working with shear-stress-sensitive cell lines and bioconjugates acknowledge benefits of the rocking motion technology.

The modular concept of the Biostat^® RM portfolio, ranging from 2 L to our unique 200 L, provides flexibility to manage your individual process needs. Biostat^® RM saves space, reduces costs, and increases yields. In addition, Biobrain^® – the commercial manufacturing-ready automation platform shared between Biostat^® RM and Biostat STR^® – enables a seamless transfer from product development to manufacturing scale. This makes the Biostat^® RM an integral part of the intensified seed train.

Clipster^® Aseptic Point-of-Use Disconnectors Clipster^® is a single-use solution for disconnecting tubing at any stage in the process while maintaining sterility. Its unique design allows installation on assembled products. The Clipster^® is robust, quick and easy to use. Operators perform the disconnection with a handheld tool, ensuring quick and easy execution even in limited space. As Clipster^® is not in contact with any fluids, it can be easily validated.

Clipster® was designed to meet the demand for increased flexibility within disconnection operations in the biopharmaceutical industry. Clipster® can serve as validated backup for unplanned disconnections. Its simple 4-step process (without product contact) eases validation and supports disconnections from R&D up to commercial production scale.

Key Features

1. Point-of-Use Installation
   At any point during assembly and processing, an operator can aseptically disconnect units

2. 4-Step Operation
   Easy-to-use operation ensures quick, robust, and repeatable disconnection
3. Sterility Assurance
   Proven during validation with bacterial challenge via immersion in Bacillus astropheus at 106 CFU/mL

The Sartocheck® 5 Plus perfectly meets today’s key industry requirements for filter integrity testing in demanding GMP environments. By combining a unique approach to Quality Risk Management, with optimal data integrity, intuitive usability and minimized risk factors for Health, Safety and Environment (HSE), it sets a new standard for filter integrity testing devices.

The regulatory focus on QRM (cf. ICHQ9 and the new Annex 1 written by EMA in cooperation with the US-FDA, WHO and PICs) also applies to filter integrity testing, as a fundamental element of sterility assurance.

The Sartocheck® 5 Plus Filter Tester uses program specific parameters allowing the automatic identification of testing anomalies in advance or during the test. This avoids time-consuming and costly deviations, potential drug recalls and 483 warning letters.

The Fast, Flexible and Intelligent Single-Use Mixer for All Mixing Steps in cGMP Bioprocessing.

Quality and efficiency are critical when it comes to mixing operations in a bioprocessing environment, and the choice of mixing equipment can dramatically affect both. In fact, a fast and flexible single-use mixer can be a competitive advantage, helping manufacturers maximize throughput and increase production.

This is what 20 years in single-use fluid management has taught us — and what we heard from customers. The Flexsafe^® Pro Mixer was designed with those principles in mind.

With the flexibility to accommodate both low-shear and rapid-mixing applications, the Flexsafe^® Pro Mixer brings unique single-use technology to a wide range of mixing steps in upstream and downstream processes.

The Flexsafe^® Pro Mixer supports quality and efficiency by reducing the risk of operator error, allowing inline monitoring and control and protecting shear-sensitive products. These benefits, along with fast installation and easy setup, make the Flexsafe^® Pro Mixer a long-term investment with an immediate return.