BPI White Papers

Accelerating Antibody Discovery through Gator® BLI Biosensor Technology

The development of antibodies for diagnostics or therapeutics requires comprehensive characterization of affinity, specificity, and mechanism of action. Affinity measurements could screen different isolates of an antibody to identify those that are most effective at binding antigen. Also, measurements of the capacity of an antibody to bind other compounds that are structurally related to the original immunizing antigen can help establish the likelihood of whether an antibody will cross react non-specifically with other molecules that might accompany the antigen. Binding…

Transitioning from Quantitative PCR to Droplet Digital PCR for HEK293 Host Cell DNA Residual Testing

HEK293 cells are a dominant platform for cell and gene therapy production because they are highly effective at producing large amounts of recombinant viral vectors. However, it is critical to remove trace host cell contamination from therapeutic products to avoid endangering patients. To meet rigorous regulatory guidelines, biopharmaceutical manufacturers need a HEK293 detection method that delivers high-quality, quantitative data with a simple, reliable workflow. This white paper discusses the transition from quantitative PCR (qPCR) to Droplet Digital PCR (ddPCR™) for…

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…

Increasing Dynamic Binding Capacity of Oligo(dT) for mRNA Purification: Experimental Results Using CIM 96-Well Plates

Messenger RNA (mRNA) emerged as a powerful therapeutic tool for treatments in gene therapy, oncology, and infectious diseases, as recently demonstrated by vaccines against Covid-19. mRNA is produced by an enzymatic reaction that can be rapidly designed and scaled-up, and the platform is highly adaptable to different targets. One of the greatest challenges in mRNA production is the removal of process-related impurities stemming from in vitro transcription (IVT) reaction, such as residual nucleotide triphosphates, DNA template, enzymes, abortive transcripts. Affinity-based…

Current Trends in Antibody Drug Conjugates (ADCs) Characterization: Expert Paper

We bring you a brand-new paper focused on Current Trends in Antibody Drug Conjugates Characterization, focusing on structure. Comprehensive structural, biophysical, and physico-chemical property characterization in alignment with Chemistry, Manufacturing and Controls (CMC) guidance is a requirement to achieve successful regulatory (IND) submissions. Multiple analytical technologies are required for ADC analysis with a focus on the drug’s critical quality attributes (CQA), with data interpretation conducted by experienced biopharmaceutical analytical scientists. In this review, we discuss the current trends in antibody…

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…

Regulatory Considerations for Excipients used in Lipid Nanoparticles

Lipid excipients and delivery systems such as lipid nanoparticles (LNPs) are essential for a wide variety of therapeutics including chemotherapy, analgesics, gene therapy, respiratory and ocular applications, anti-fungal applications, and vaccines. In many cases, these excipients and delivery systems play an important role in achieving the desired bioavailability. mRNA vaccines, for example, require incorporation of lipids to prevent degradation of the nucleic acid and facilitate cellular uptake of the mRNA which is required for antibody generation. The purity and safety…

Time-To-Market Record: Major EPCM Project in Just 24 Months

Boehringer Ingelheim and ZETA have had a long-standing, successful partnership. In 2019, the global pharmaceutical company approached ZETA with a significant challenge. The goal was to implement a major EPCM project at the Boehringer Ingelheim RCV site in Vienna, Austria, in just 24 months. ZETA accepted the challenge and successfully managed the entire project – called G3Leopold – as a one-stop-shop for the customer. Everything was included: from the engineering of the entire plant, the process area, the architecture, and…

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…

Selecting the Best Transfection Method – When to Use Transfection Reagents, Viral Transduction or Electroporation

No single delivery method is ideal for all situations, but researchers may routinely employ a suboptimal approach for the sake of familiarity or to avoid any start-up costs associated with new methods. In this white paper, we will describe three methods (chemical, electroporation and viral transduction) and highlight the Mirus Bio TransIT® transfection reagents and Ingenio® EZporator® Electroporation System, which are both easy to use and cost-effective.