Monoclonal antibodies (mAbs) are highly complex biomolecules easily affected by changes in the biopharmaceutical manufacturing process. Something as simple as a temperature fluctuation can produce a change in higher order structure (HOS) that renders the mAb less active or inactive. Whether your mAb is an original product or a biosimilar, our comparability studies are designed to ensure robust and reproducible mAb production.
Our Product Characterization services offering combines mAb physicochemical and structural information with the activity profile captured from binding, affinity, and potency bioassays to better understand the function of your drug—its critical quality attributes. All testing is performed in a GMP qualified laboratory and is compliant with ICH guidelines, FDA, and EMA regulations.
Many different impurities are present in or generated during the mAb manufacturing process. We work to make sure your biotherapy’s development program isn’t derailed by process or product contaminates that can arise from raw input materials, occur as residual processing agents, or formed as reaction by-products.
Before your mAb therapy reaches a patient, it is important to ensure product safety and efficacy. This includes understanding the effects of environmental conditions—temperature, humidity, light, container interactions—on your mAb. We offer a full portfolio of lot release and stability testing services performed to GMP guidelines.
The ambr® 250 modular bioreactor vessel is designed for gentle stirring and optimum growth of cell lines and offers a cost-effective, scalable process development of cell and gene therapies solution.
The ambr® 250 modular is an innovative new high performance benchtop bioreactor system for parallel microbial or cell culture in 100 - 250 mL single-use vessels.
The Thermo Scientific™ HyPerforma™ Glass Bioreactors are available in 1, 3, 7, and 15 L sizes. They offer easy operation and rapid assembly and are manufactured with the highest standards for materials and surface finish. Developed using a computational fluid dynamics (CFD) simulator, the HyPerforma Glass Bioreactor impellers provide maximum mixing with minimum shear force, resulting in a higher average kLa. The cold finger has been replaced by a cooling loop to increase the thermal surface. Laboratory performance tests have demonstrated a cooling rate two times better than a sample of products from other suppliers. Control can be bidirectional, which allows a single-wall vessel to be used for mammalian applications and fermentation processes* (needs two kits).
Read more about solutions offered from Thermo Scientific including the HyPerforma™ G3Lite™ Controller, TruBio upstream software, HyPerforma S.U.B., TruFlow gas mass flow controller (MFC) and other products for your process development and production operations.
Flexible, reliable, and configurable bioprocessing solutions
The Thermo Scientific™ HyPerforma™ G3Lite™ Controller is an open architecture control system that can be integrated with any single-use bioreactor such as the Thermo Scientific™ HyPerforma™ Single-Use Bioreactor (S.U.B.) (Available in sizes ranging from 50 L to 2,000 L). The system consists of a control tower that leverages intelligent transmitters, mass flow controllers (MFCs), pumps, sensors, and Thermo Scientific™ TruBio™ software that facilitates easy, reliable, and repeatable process development and commercial cell culture processes. HyPerforma G3Lite Controllers are fully self-contained, movable units that can be operated as stand-alone (for 1 vessel) or networked for multiple vessels. They are engineered to optimize capital cost for use in non-GMP and cGMP-certified production facilities.
Reliable Process Control
The Thermo Scientific™ HyPerforma™ G3Lab™ Controller can control most brands of single-use or autoclavable bioreactors or fermentors that are ≤50 L, including stirred- tank and rocking models. The controller operates using Thermo Scientific™ TruBio™ software, which provides easy process scale-up or scale-down and the configurability to modify your control strategy along with your process. The enclosure contains state-of-the-art transmitters along with power supplies, pumps, input/output (I/O) modules, and the hardware required to connect to the control network, providing maximum control capability.
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