Specific risks associated with SUS integrity assessed as part of the contamination control strategy (CCS).

Virus filtration is a robust mechanism to ensure virus safety of biotherapeutic manufacturing processes and must be validated under simulated worst case pr...

This panel discussion was recorded during the Process development virtual summit in June 2025. The discussion is featuring the R&D scientists behind Cytiv...

Ion exchange chromatography (IEX) is one of the most applied unit operations in the downstream processing of complex biomolecules. The performance of such ...

In silico process development, and especially mechanistic modeling, is gradually gaining acceptance in the bioprocessing industry. In this talk, we explore...

All your efforts and focus on discovery and preclinical work are finally coming to a successful culmination, and now you need to quickly move into clinical...

Here we explore a case study on optimizing and scaling up a plasmid DNA process. Our Fast Trak™ process development services team used design of experiment...

The number of monoclonal antibodies (mAbs) with high-concentration formulation is expected to grow annually by 13% between 2024 and 2029. Meeting this dema...

Due to the high cost and complexity of using real viruses in process development, virus clearance is traditionally tested only in phase 1 and 3 clinical tr...

In silico chromatography process development with the GoSilico™ chromatography modeling software can speed up PD work and simultaneously improve process un...

Using modeling during process development can improve efficiency. In this presentation we discuss the benefits and considerations for process development s...

In this presentation you will learn about how ÄKTA™ avant chromatography system can be used to design in buffer formulations to be used in large scale inli...

In this presentation we describe and evaluate various strategies for the monoclonal antibody (mAb) capture step. We look at factors to consider when choosi...

The US FDA considers buffers as crucial raw materials in the production of active pharmaceutical ingredients (APIs) or intermediates from cell culture or f...

Trace metals in complex cell culture media (CCM) can have a significant impact on critical quality attributes of recombinant therapeutic proteins. Raw mate...

Polypropylene glycol (PPG) with a 1000-2000 Da molecular weight range was recently identified as a cytostatic impurity in poloxamer 188 (P188), demonstratin...

Good bioreactor scaling strategies are important for both scale-up and scale-down in process development through commercial manufacturing. Learn the ins an...

Risk analysis and practical solutions for pre-use post-sterilization integrity testing (PUPSIT) implementation. Learn more about PUPSIT without the pain.

While digital transformation is the way of the future, knowing where and how to start your organization’s journey toward digital evolution can be challengi...

Manufacturing challenges with high concentration biologics. Challenges associated with the higher concentration of active ingredients and formulation compo...