Author Archives: BPI Contributor

Ending CO2 Transmission Problems Using Purillex® Containers

This webcast features: Eric Isberg, Vice President, Life Sciences, Savillex. 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. This webinar outlines two studies performed by a major biopharmaceutical company to determine the closure style and torque specification of Purillex® PFA bottles required to ensure no carbon dioxide ingress during storage and shipping of BDS products on dry ice. Key takeaways: Understand the correlation…

Accelerating Cell Line Development with an Efficient, Combined Platform Approach

The determination of product critical quality attributes (CQAs), key process parameters and indicators (KPPs and KPIs respectively) is a critical step for process efficiency during cell line development. Thousands of clones are typically screened with the goal of finding those that are stable, produce high yields of the bioproduct and exhibit desired CQAs. Screening and process optimization activities are typically carried out at the small scale in bioreactor cultures and are aimed at ensuring that results translate to larger bioreactor…

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.

Analytical Tools to Improve Production of Full Capsids in Initial Stages of AAV Process Development

This webcast features: Ivana Petrović Koshmak, PhD, Head of Upstream Process Development, BIA Separations, now a Sartorius company. Empty AAV capsids are known contributors of immunogenicity in gene therapy products. Reducing them below 10% during downstream process is difficult if they constitute the vast majority of total AAV produced in harvest – the solution is a further optimization of harvest. Determining the factors that improve production of full AAVs is possible at the initial stages of upstream process development, with…

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 and challenges in passage through the intestinal membrane, a key step to entering the systemic circulation. As such, formulators have developed a toolkit of enabling formulation techniques to increase bioavailability, including solid-state modification, formulation with lipids, and complexation with cyclodextrins. However, the high degree of complexity of these approaches, as…

Streamline cGMP Viral Vector Analytical Challenges With Robust and Sensitive Impurity, Fragment Sizing, and Oncogene Quantitation Assays

This webcast features: Jonas Buege, Product Manager, Thermo Fisher Scientific. The therapeutic potential of viral vector-based gene therapies is tremendous, but with some recently adverse outcomes in clinical trials, the safety of these drugs has come into question. Both regulatory agencies and manufacturers are working hard to define appropriate critical quality attributes and identify process-related impurities crucial to ensuring patient safety. These requirements increase the demand of analytical development teams working on viral vectors, over traditional biopharmaceuticals, to utilize novel…

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…

Comprehensive Virus Clearance Evaluation Using Micro-Scale Membrane Adsorbers

This webcast features: Sherri Dolan, Global Technology Consultant for Virus Clearance, Sartorius. When it comes to establishing a viral clearance process, ensuring patient safety is a top priority. To ensure this, regulators require that manufacturing processes have a validated cGMP purification process that can remove and/or inactivate a variety of viruses. Additionally, process efficiency and cost, among other factors, play a role in small- and large-scale manufacturing processes. Many biopharma manufacturers are not yet utilizing the full loading potential of…

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…