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Development of Allergen Immunotherapies

Desentum, a biopharmaceutical company that specializes in developing allergen immunotherapy (AIT) products, has partnered with contract development and manufacturing organization (CDMO) Biovian to advance hypoallergens based on targeted modifications to recombinant proteins. I spoke with Kati Sallinen (director of strategy and communications at Desentum) and Jonne Vaarno (project manager at Biovian) about their companies’ development of AITs and a potential platform to treat different types of allergies. Our Discussion We all know someone with an allergy, and many people have…

Improving Gene Therapy Viral Vector Manufacturing Economics: Modelling Bioprocess Costs

Gene therapy viral vector manufacturers strive to reduce time to market and cost per dose to ensure treatment affordability and patient access. Approved and commercialized AAV-based gene therapies Luxturna® and Zolgensma®, for patients suffering from vision loss and spinal muscular atrophy, are the first of many gene therapies that are expected to reach the market in the coming years. One major bottleneck is the cost per dose of the treatments, with Luxturna® costing almost half a million dollars per eye…

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…

Delivering on the Promise of Bispecifics: State-of-the-Art Bispecific Antibody Development

Bispecific antibodies (bsAbs) have transformed the field of immunotherapy. However, moving these life-changing therapeutics from the bench to the clinic can be time-consuming and costly. Further, challenges such as aggregation, degradation, fragmentation, and denaturation may ultimately hinder a program from advancing to the clinic. Partnering with a CDMO with relevant experience and technologies can be critical for safely and cost-effectively manufacturing bispecific antibodies. With Selexis’s cell line technology and KBI Biopharma’s manufacturing and analytics, we lead the industry in technologies…

Stability Assessment of mRNA Formulations – Toward the Development of Degradation Assays for mRNA-based Vaccines

This webcast features: Caio Henrique Barros, PhD, Research Scientist, National Institute for Bioprocessing Research and Training & James Geiger, PhD, Field Application Scientist, PerkinElmer. The COVID-19 pandemic has demonstrated the potential of mRNA vaccines to protect against infectious diseases. These unprecedented circumstances have also highlighted the instability of the mRNA molecule, which required the first COVID vaccines to be distributed at ultracold temperatures. This limitation has intensified efforts to develop mRNA formulations that are sufficiently stable at room temperature. Dried…

LentiVector platform: The first and leading commercial lentiviral-based gene delivery system

Oxford Biomedica’s LentiVector platform, which delivered the first FDA and EMA approved CAR-T cell therapy, enables the successful development of breakthrough gene and cell-based medicines. Discover more about the platform and our long and broad clinical and commercial track record, which spans over 25 years. Oxford Biomedica’s LentiVector platform enables the successful development of breakthrough gene and cell-based medicines. We have a long and broad clinical and commercial track record in the gene therapy field spanning over 25 years. Our…

Biologics Manufacturing Without the Big Bioreactors

Over the past few decades, the biotechnology industry has brought to patients a medical revolution with the most advanced medicine ever seen. Yet much of the world’s population cannot afford or get access to these breakthrough therapeutics. That is in part a consequence of the high associated costs of development and biomanufacturing, extended times for regulatory review and approval, and a lack of regional manufacturing and dependable supply chains (because of facility costs and a scarcity of expertise). The recent…

Using Monolith-Based Chromatography to Monitor In Vitro Transcription Reactions

In vitro transcription (IVT) is a critical step in messenger RNA (mRNA) production. In a March 2022 webinar, Rok Sekirnik (head of process development for mRNA and plasmid DNA (pDNA) applications at BIA Separations, part of Sartorius) explained that optimizing concentrations of reagents used during IVT helps to maximize the amount of mRNA that is produced. Drug developers have great need for analytical methods that can measure IVT in real time. Sekirnik showed how CIMac PrimaS monolith chromatography columns enable…

Ask the Expert: Using High-Throughput Analytical Systems to Facilitate Binding-Kinetics Assays

Critical quality attributes (CQAs) must be characterized thoroughly to establish a biopharmaceutical’s potency, efficacy, and safety. Such characterization involves some of the most difficult analytical activities that are performed in a biologic’s product life cycle. There is great need for analytical tools that can facilitate such studies. In March 2022, Dr. Kalhari Silva (head of scientific research at Custom Biologics) and Dr. Bob Dass (senior scientist at Sartorius) joined BPI to describe how Octet biolayer interferometry (BLI) technology can be…

High Performance With GMP Ready CHT Prepacked Process-Scale Columns

This webcast features: Khaled S. Mriziq, PhD, Senior Marketing Manager, Process Chromatography, Bio-Rad Laboratories. In this webinar, we will present performance data for the newly launched, GMP ready CHT™ Ceramic Hydroxyapatite prepacked process-scale columns. This will include HETP and asymmetry data that shows excellent column performance and shipping stability over a range of column diameters. The columns are designed to eliminate any headspace formation during transportation. Cycling and pressure data will also be presented. Foresight Pro Columns can be used…