Sartorius Lab Instruments

Small-scale, multi-parallel bioreactors provide more process information for culture comparison in less time. Multiple experiments can assess different clones or cell lines, as well as the effects of pH, temperature, feeding, media, gassing rates and inoculation densities.

Ambr® multi-parallel bioreactors can handle your upstream process steps, from clone or cell line selection to process optimization, ensuring scalability because process data translates well into the 2L Univessel® SU and larger Biostat STR® systems.

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.