September 2020

Ask the Expert: Translating Inhaled and Nasal Technologies for Biologics Delivery

Gastric delivery is unachievable for most biopharmaceuticals, so drug developers formulate biologics primarily for intravenous infusion or injection. However, inhaled and nasal delivery options are attracting considerable attention because they enable targeted delivery of a wide range of therapeutic proteins. On 23 June 2020, Mark Parry (technical director at Intertek) presented an “Ask the Expert” webinar that described critical considerations for inhaled and nasal delivery for biologics. Parry’s Presentation Because biopharmaceuticals are complex products, developers need compelling reasons to choose…

Ask the Expert: Ultrapure Gelatin Can Optimize Your Excipient Screening for Vaccine Formulation

In his 28 May 2020 “Ask the Expert” presentation, Jeroen Geeraerts (business development manager at Rousselot) highlighted that, as of May 2020, 118 candidate vaccines for the novel coronavirus (SARS-CoV-2) had reached clinical or preclinical evaluation. Of those, 11 use inactivated and live–attenuated approaches, which require strong stabilizing agents to maintain vaccine potency. Geeraerts explained why inactivated and live–attenuated vaccines require stabilizing agents and why vaccine companies prefer pharmaceutical-grade gelatin for such applications. Next, Geeraerts described how his company’s X-Pure…

Ask the Expert: An Innovative System for Advanced, High-Throughput Aggregate Analysis

Distinguishing aggregated active pharmaceutical ingredients (APIs) from other particle types is critical to evaluating a protein product’s stability, but standard characterization tools struggle to discriminate proteins from nonproteins with similar sizes, shapes, and morphologies. In a 25 June 2020 “Ask the Expert” webcast, Bernardo Cordovez (founder and chief scientific officer of Halo Labs) introduced his company’s Aura subvisible-particle analyzer. He explained how the device combines an innovative microscopy technique with sophisticated imaging software to characterize subvisible particles more quickly and…

Democratizing Access to Cancer-Related Proteomic Data

The US National Cancer Institute (NCI) has launched the Proteomic Data Commons (PDC), a next-generation proteomic data repository that will facilitate data access, sharing, and analysis to speed development of precision-medicine therapies for cancer. Housed within the NCI’s Cancer Research Data Commons (CRDC), PDC hosts several multiomic data sets that have corresponding genomics and imaging data elsewhere, simplifying their access to enable integrative research. Increase Access to Enable Discovery Mass spectrometry (MS)–based proteomic profiling for pancancer analyses could enhance our…

Improving Bioprocess Expression Systems: A Clean Alternative to CRISPR/Cas9

Chinese hamster ovary (CHO) cells have emerged as a robust platform for bioprocessing serving both early and late-stage biotherapeutic drug supply. However, these cells and other hosts (e.g., HEK293), can be optimized for even greater potential through advanced gene editing. For example, when the endogenous glutamine synthetase (GS) gene is knocked out in CHO cells, a sixfold increase in high-producing cell lines is achieved (1). In another study, CHO with annexin A2 (ANXA2) and cathepsin gene (CTSD) knockouts were introduced…