Ask the Experts

Effective Strategies for Endotoxin Removal in Therapeutic Protein Purification

This webcast features: Heidi Jones, MBA, Market Development Manager, Chromatography Applications & Collaborations,  Bio-Rad Laboratories. Endotoxins are common pyrogenic impurities in therapeutic protein preparations that make the next steps in the purification process very difficult. They are negatively charged complex aggregates of lipopolysaccharides released in large amounts from the outer membrane of gram-negative bacteria during mechanical cell lysis and death. Their presence in even minute concentrations in therapeutic protein preparations can cause septic shock, tissue injury, and even death. In…

A Scalable, Two-Step Purification Process for Plasmid DNA

Plasmid DNA (pDNA) plays a critical role in biopharmaceutical manufacturing — e.g., by providing a template for mRNA synthesis, delivering genes of interest to production cell lines and viral vectors, and even serving as a basis for DNA vaccines. Although plasmid production in microbial hosts is a well-characterized process, downstream purification of the needed supercoiled (sc) forms can be time-consuming, resource-intensive, and difficult to scale. The latter concern is especially problematic considering how many applications require pDNA — sometimes large…

Introducing a Multitiered Classification System for Downstream Process Intensification

Process intensification (PI) provides a holistic framework to maximize the overall productivity of unit operations, manufacturing processes, or complete facilities. In a recent BPI Ask the Expert webinar, Martin Lobedann, PhD (process technology manager at Sartorius) described how PI reduces cost of goods (CoG), whether applied stepwise or in an end-to-end process. It can be driven by targets relating to the use or chemistry of consumables, cycling strategies, durations of unit operations, batch definitions, and levels of process integration (e.g.,…

Expansion into Late Drug Discovery and Early Development

The Samsung Biologics contract development organization (CDO) service has focused traditionally on cell line, process, analytical, and formulation development. Samsung Biologics has expanded its scope to support late drug discovery and increase success in early development using the S-CHOsient transient expression system and DEVELOPICK platform, as presented by Derrick Katayama (lead scientist of formulation development at Samsung Biologics). Failure rates in drug development often stem from molecular instability or selection of the wrong candidate. In this expanded program, the S-CHOsient…

An Essential PAT Technology for Downstream Processing in AAV Manufacturing

This webcast features: Racha Majed, PhD, Technical Sales Specialist, Refeyn & Quentin Bazot, PhD, Head of Innovation and Process Development, ABL, an Institut Mérieux Company. While gene therapies relying on adeno-associated virus (AAV) vectors are in high demand, so are the analytical methods that can constitute a robust process analytical technologies (PAT) toolbox. To ensure the production of high-quality AAV products, it is crucial to reliably and rapidly characterize samples based on critical quality attributes (CQAs) such as sample purity.…

Turning Biologic Innovation Into Commercial Success: Boehringer Ingelheim’s Expertise in Microbial Technology

This webcast features: Athelney Woolnough, Director Business Development/Key Account Management BioXcellence, Franz Schuster, Strategy Implementation Manager Biopharma Austria, Nikolaus Hammerschmidt, PhD, Head of Unit Downstream Development , Process Science, RCV, Boehringer Ingelheim. Boehringer Ingelheim BioXcellence™ offers comprehensive support for successful development and manufacturing, treating customers’ products as if they were their own. Their expertise spans both mammalian cell culture and microbial fermentation technologies. The microbial product landscape, a specialty market, demands a variety of manufacturing process formats to cater to different…

Tulip Tank Case Study: The Unrecognized Role of Mixing During TFF

This webcast features: Lucas Smith, Commercial Project Manager, TFF Systems, Repligen. The degree of homogeneity in the feed that is delivered to the filters is a critical, but often overlooked factor. Even small changes in the nature of the feed will drastically impact performance, resulting in deviations during diafiltration. This case study explores the impact of mixing dynamics on TFF performance. An innovative single-use Tulip Tank paired with the KrosFlo® RS 30 TFF system significantly improved performance as compared to…

Advanced Technology for Vector-Based Therapies Highlighting Stem Cell-Derived Exosomes Manufacturing Process

This webcast features: Elie Zakhem, PhD, PMP, Senior Manager, Process Development, RoosterBio Inc., Lauren Torres, Field Applications Scientist, Repligen, Jeremy Neidert, Bioprocessing Account Manager, Repligen. The number of clinical trials investigating viral vectors and MSC-EVs as therapeutic and skincare agents has been increasing greatly over the years. The complexity and fragility of the vector-based products, scalability, yield, and purity of production processes are challenges to meeting demand. With this comes the requirement to ensure that there are robust manufacturing processes…

Unmatched Productivity and Seamless Scalability: Advantages of the XCell® ATF System for Upstream Process Intensification

This webcast features: Muhammad Shamim, Field Applications Scientist, Upstream, Repligen. With the constant pressure of meeting aggressive process development timelines while continuously improving upstream cell culture yield and productivity, developing the optimal processes from the beginning is crucial. With over 500 adoptions at process and commercial scale across biopharma globally, the XCell® ATF System is a proven technology for intensified cell culture that exponentially boosts productivity, lowers costs, and expands capacity of existing manufacturing facilities in upstream bioprocessing. In this…

Innovation in Tangential Flow Filtration: Holder-Less Self-Contained Flat Sheet Cassette Device

This webcast features: Mark A. Perreault, Director, Research and Development, Repligen Tangential Flow Filtration (TFF) has been a cornerstone technology in bioprocessing, enabling the separation and concentration of biomolecules with precision and efficiency. In this study, we introduce a groundbreaking innovation in TFF technology with the launch of the first holder-less self-contained true flat sheet cassette device. This device represents a paradigm shift in TFF, eliminating the need for traditional cassettes holders while delivering performance comparable to conventional formats. In…