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.
An organized effort across the biopharmaceutical industry, including drug substance manufacturers and suppliers, is needed to address and meet the needs of industry regarding raw material quality and consistency.
Are the methods used for developing the current generation of biopharmaceuticals, monoclonal antibodies, hormone replacements, etc., applicable to the next generation of Cellular and gene therapies?
Our technical automation and instrumentation experts continuously evaluate and implement automation technologies and systems that move us toward Industry 4.0. Our experts deliver solutions in automation strategies and evaluation, SCADA and control system upgrades, building automation, and technology obsolescence management plans.
Using our integrated EPCMV process allows us to deliver exceptional manufacturing facilities to the clients we serve. We understand the complex nature of the systems and structures in the facilities we produce. From bioreactors to powder transfer systems, cosmetics to medical devices, we are at the forefront of the latest advances in the industry. Our approach takes a holistic view of each project. We provide the latest, proven concepts to deliver exceptional results for the clients we serve.
Autologous (patient-derived) therapies represent unique challenges to processing. One-patient, single-batch is a radical change from the scale our industry is accustomed to. At this level the filling is more analogous to limited Phase 1 clinical trial materials or even preclinical applications. The logistics and required compliance of manufacturing these personalized therapies is drastically different and presents a combinatorial explosive problem. One aspect of this process where traditional methods fall apart is filling of these therapies.
In our tutorial series on viral vector production, GE scientists share their insights on virus production and how to tackle viral vector manufacturing challenges. In one episode a scalable production process for adenovirus is presented.
Cost, clean-up and downtime are just a few things to consider when construction a cleanroom. Following is an overview of the advantages of modular project execution versus stick-built construction.
Material and specifications of the cGMP compliant, FM Global Approved AES Pharma Wall and AES Pharma Walkable Ceiling systems.
Challenges to overcome in the CAR T manufacturing process include lengthy production times 11 21 days), product variability associated with open handling steps, and high manufacturing costs Here we examine and evaluate individual CAR T cell unit operations, commercial reagents, and equipment with process closure potential to develop an improved workflow and increase product consistency.