As manufacturers across the industry continue to pursue mRNA-based therapies, it is important they understand the challenges they may face in their journey and what solutions could help overcome them.

The need to increase efficiency and productivity has led scientists to develop a machine learning solution that can optimize the way that developers analyze and characterize their early drug candidates.

Iwan Bertholjotti, director of commercial development of bioconjugates, and Dr. Bernhard Stump, head of development of bioconjugates, discuss the complexity and uncertainty that defines the bioconjugates market and how companies can position themselves to mitigate that uncertainty at every stage of development.

In this study we evaluate the performance of the Pall NAB Nanosep centrifugal device for the isolation of SARS-CoV-2 viral RNA from human saliva samples spiked with heat inactivated virus using reagents (RCOM1 and RCOM2) from two commercially available kits for extraction of viral RNA.

The most problematic step in the purification of synthesized biomolecules is the clarification of the sample once the cells are lysed. The lysate often contains biomolecule concentrations millions of times higher than the molecule of interest. Here we present a lysate sample preparation procedure using the AcroPrep™ Advance filter plate for lysate clearance that effectively removes unwanted cellular debris from samples.

Standard techniques often involve multiple purification steps, each associated with significant product losses, therefore requiring large amounts of starting DNA to guarantee sufficient vector and insert material to complete subsequent ligation and transformation steps. In this paper, we describe the use of these ultrafiltration devices in various steps of the cloning workflow that can provide a more streamlined process and compare them against traditional methods of subcloning PCR-generated fragments.

Overexpression of proteins has enabled access to highly purified proteins in large quantities for research and increasingly for medical purposes. However, the clarification process can be quite cumbersome, especially during early discovery, when working with multiple cultures of relatively small culture volumes. This application note demonstrates how the Pall AcroPrep 24-well Cell Clarification and Sterile Filtration Plates have proven quite useful for clarification of mammalian cell cultures such as CHO-cells, by combining the cell clearance and sterile filtration functionality in a single device.

Realizing the potential of mRNA requires focus on key areas and strategies that could help alleviate the bottlenecks in this growing market segment.

William B. Jones, Senior Vice President of Pharmaceutical Development at Corvus Pharmaceuticals, discusses his company’s selection of CDMO for its CPI-006 antibody program, which is currently under development as an oncology drug and investigation as a therapeutic for immune disorders and infectious diseases.

Companies that want to accelerate their biomanufacturing operations and use their resources efficiently need access to technologies and solutions that can safely and efficiently complete their workflow from idea to injection.