See how the different unit operations in a laboratory-scale monoclonal antibody (mAb) process can be connected and integrated into a semi-continuous process.
Building upon the success of the robust HyPerforma bioreactors first launched in 2006 and updated in 2013, we introduce our newest innovation: the Thermo ScientificTM HyPerformaTM DynaDrive Single-Use Bioreactor. This single-use bioreactor was designed to accommodate modern cell culture processes and has features that will help you save time and costs and enable your bioprocessing and scale-up success.
Improvements in single-use systems have allowed implementation of high-demand cultures in emerging bioprocess workflows, while progressive advances in media optimization and improved clone genetic selection have underscored the perceived performance limitations of single-use bioreactors (S.U.B.s). This study presents how strategic enhancements of Thermo Scientific™ HyPerforma™ S.U.B.s have revealed improvement in mixing and mass transfer performance compared to legacy S.U.B. designs.
Adherent cell cultures, such as those with Vero cells, are often more challenging than their suspension-based counterparts with scale-up methods that require optimization of agitation and other operating parameters. This application note presents how Thermo Scientific™ HyPerforma™ Single-Use Bioreactors (S.U.B.s) can be enhanced for scaled-up growth of adherent cells on GE Healthcare Cytodex™ 1 microcarriers in serum-free medium, in culture volumes of 50 L, 250 L, and 500 L.
With many end users now demanding streamlined operations, high-density culture in fed-batch modes, even higher production by perfusion cultures, and contrastingly gentle operations required in microcarrier applications, standard S.U.B. offerings must keep pace with the ever-evolving needs of the bioprocessing industry. Read about recent enhancements that are helping keep up with these increasing demands.
Learn what challenges exist when developing biologic drugs to be efficacious but safe and how novel analytical techniques, like surface plasmon resonance, can help circumvent these issues and optimize development.
Biomolecules are becoming more complex. Bio-Rad’s newest hydrophobic AEX chromatography resin, Nuvia aPrime 4A, is designed with distinctly balanced modes for better interactions to purify your toughest targets. Now you can triumph with even the most challenging biomolecules. Learn more about Nuvia aPrime today and experience a wider design space delivering high purity and yield.
Bispecific antibodies (bsAbs) represent a fast-growing class of molecules offering new therapeutic perspectives. Their development is still hampered by the difficulty to produce such complex molecules composed of multiple polypeptide chains. Therefore, producing bsAb in a single-cell system, whatever the format, turns out to be the most attractive strategy.
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.