Downstream

Solving Cost and Supply Challenges in Biopharma Downstream Processing

In only five years, the number of FDA approvals for monoclonal antibody (mAb) therapies has more than doubled. These therapies continue to lead resource investment as biopharmaceutical companies drive to get these innovative, life-changing therapies to market faster. Yet mAbs downstream processing — which accounts for roughly 60% of the production cost of a biologic drug — hasn’t kept up with advances in upstream processing. Much of this challenge stems from downstream processing’s need to move biological materials through a…

Critical Steps to Consider During Customized Host Cell Protein (HCP) ELISA Development

The manufacturing of recombinant drugs requires comprehensive monitoring of process-related impurities, such as HCPs, as they may pose a significant health risk to patients. EMA and FDA approval relies on robust analytical data to prove acceptable HCP clearance. The enzyme-linked immunosorbent assay (ELISA) is the gold standard method for monitoring HCP content during product development and batch release testing within clinical and commercial phases. Supporting data from various orthogonal methods, including 2D Western Blot/2D DIGE analysis and mass spectrometry, should…

Designing a Plasmid DNA Downstream Purification Process

mRNA plasmid-based DNA vaccines, and advanced modalities using viral vectors, are at the forefront of the fight against cancer, cardiovascular, immunological, and infectious diseases. To reach their full potential and benefit as many patients as possible, however, workflows used for their manufacture must achieve greater efficiency. A critical step in the process is production of plasmid DNA (pDNA), which traditionally, delivers low yields and requires complex purification schemes. This new process development book provides you with guidance for your plasmid…

Innovations in Single-Use Technology Help Advance Downstream Processing

Biopharmaceutical manufacturers across the globe are trying to rapidly expand their production capacity to meet the growing demand for new therapies. A key challenge they face is to scale that expansion cost-effectively while protecting the quality and integrity of their production processes. One way they are achieving this growth is through expanded use of single-use systems (SUS). This informative new Avantor® Technical Article details several ways SUS technology can help improve throughput and productivity in key downstream processes that routinely…

Case Study – Merck Process Transfer and Scale-Up of Batch Chromatography to Multi-Column Platform

Traditional batch chromatography has high operating costs. Merck sought to evaluate the relative performance and costs of an MCC system. Learn how Merck achieved resin savings and productivity gains by implementing multi-column chromatography with the Sartorius BioSMB System. Key Learning Objectives: Learn how Merck achieved 3.5x higher productivity with MCC compared to batch mode See how the shift resulted in 80% reduction in chromatographic resin use Find out how Sartorius experts supported Merck’s process transfer Access this case study and…

Visit and work with the M Lab™ Collaboration Centers from the comfort of your own lab

Welcome to the M Lab™ Collaboration Centers where life science innovators come to explore big ideas, learn new techniques, and rapidly move from complex problems to just-right solutions–together. Using world-class remote technologies, you can do all this from the comfort of your own lab! We have expanded the walls of our labs by using the latest technology to bring you virtual visits or livestream trainings to support all areas of process development, implementation, and optimization. When you bring a problem…

Converting an ELISA Assay into an Octet® BLI Quantitation Assay

Enzyme-linked immunosorbent assays (ELISA) are routinely used to quantitate molecules and despite their popularity, these assays are labor- and time-intensive. Quantitation assays on the Octet® platform can be considered automated forms of ELISA but allow a myriad of benefits compared to standard ELISA assays, notably the ability to detect lower affinity interactions and a reduced hands-on time for the scientist. As with ELISA, the signal reported in quantitation assays is either directly or inversely proportional to the amount of bound…

CO2 Transmission Into Bulk Drug Substance Containers

Ingress of carbon dioxide into bulk drug substance (BDS) containers that are stored and shipped on dry ice is a serious and often understated problem. Bottles are a container of choice for freezing and shipping BDS due to their durability and convenience, compatibility with standard laboratory equipment, shelving and racking, and standard shipping containers. However, not all bottles are tested for CCI, nor does this testing guarantee leak-free performance once frozen. Carbon dioxide can readily enter bottles either through the…

Virtual Demonstration of the BioSMB Multi-Column Chromatography Platform

In this virtual demonstration, our intensified processing solutions expert provides a virtual demonstration of the BioSMB multi-column chromatography platform — a fully scalable single-use solution that reduces resin usage and enables manufacturers to explore continuous processing. The demo starts with an overview of the BioSMB PD system for small-scale manufacturing and then continues with the BioSMB Process systems for clinical and commercial manufacturing. Key learning objectives: Learn how the BioSMB system offers a 3-5 fold increase in productivity, yielding up…

The Critical Role of Predictive Bioreactor Characterization in Pharmaceutical Process-based Upscaling

In bioreactors, microorganisms or cell cultures produce complex therapeutic proteins and other biopharmaceuticals. The industrial production of those active pharmaceutical ingredients usually involves a seed train: the cells are run through many cultivation systems, which become larger with each passage (Upstream Process). An adequate number of cells for the inoculation of large-scale production bioreactors of 10,000 liters or more is generated. A prominent example from the growing mammalian cell culture processing sector is the upstream production process of monoclonal antibodies.…