BPI White Papers

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.

Application Note: Early-Stage Process Optimization for Seamless Scaling of MSC Therapies

A single dose of MSC therapy could consist of billions of cells per patient. To sustainably meet this clinical demand, cell expansion processes must be transformed from static cultures to suspension-based systems. This application note describes an efficient approach to process optimization in a scale-down model for suspension-based cell expansion. Read more to learn how to: • Comprehensively screen media and components for optimal cell growth • Rapidly characterize phenotypic and functional CQAs of MSCs • Develop process knowledge early…

Your Ultimate Guide to CMC Testing Support for Gene and Cell Therapy

The development of Advanced Therapy Medicinal Products (ATMPs), such as gene and cell therapy products, has made significant progress in the treatment of many diseases, including cancer, genetic, and autoimmune disorders. With the promise to enhance treatment, greatly reduce side effects, and potentially cure many types of diseases and disorders, these therapies are in high demand, and biopharma companies are in a race to the clinic. However, these technologies are very complex in nature and are vastly different than traditional…

Poloxamer: A Simple and Powerful Solution for Accelerating Dissolution

While oral administration remains the most popular route for drug delivery, many of the active pharmaceutical ingredients (APIs) in use and development today exhibit low bioavailability, owing to low solubility which leads to a lower passage through the intestinal membrane, a key step to enter the systemic circulation. As such, formulators have developed a toolkit of enabling formulation techniques to increase bioavailability, including solid-state modification, formulation with lipids, salt formation with meglumine and complexation with cyclodextrins. However, the high degree…

Simplifying Biotherapeutic Manufacturing and Quality Control with Label-Free Biosensor Technology

Bio-Layer Interferometry (BLI) systems are used throughout biotherapeutic discovery, development, manufacturing and quality control (QC) workflows to simplify and streamline measurement of process and product attributes. They offer an excellent alternative to assays performed using time- and labor-intensive methods such as ELISA and HPLC. These label-free assays can be run fully automated, require much less user intervention, and provide a simplified workflow. Following an introduction to the principles of BLI, we highlight how the Octet® BLI platform has been used…

Keys to Establishing a Robust Mammalian Cell Line Development (CLD) Platform

Risk management and the establishment of a robust mammalian cell line development (CLD) platform is key in the effort to bring biologics into the clinic as quickly as possible while also achieving high productivity and maintaining expected product quality. Utilizing the same mammalian cell platform early in the lead molecule discovery efforts as that used for eventual GMP production provides critical manufacturability and developability data while also delivering consistent cell culture growth characteristics and product quality and titer information to…