Sponsored Content

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.…

Simplifying the Route to GMP with a
Risk-Based Approach to Single-Use Implementation

Adopting single-use systems (SUS) is an attractive solution for current challenges within the biopharmaceutical industry. However, before implementing single-use solutions, biomanufacturers must ensure that the required SUS product quality attributes are met. In this special report, subject-matter experts from Sartorius provide insights into SUS implementation strategies for biopharmaceutical manufacturing. Their discussion covers four pillars: forming a regulatory strategy, addressing flexible radiation-sterilization processes, assessing extractables and leachables (E&L), and assuring system integrity and robustness. Then, the writers present a case study…

ADC Development and Manufacturing: Simplify, Derisk, and Accelerate the Timeline

Antibody–drug conjugates (ADCs) are complex therapeutics that offer a unique combination of selectivity and potency. Commercial demand for ADC therapeutics is projected to continue to increase while facing a very complex development, manufacturing, and supply chains challenges. Given the complexities of ADC development and manufacturing, there are clear advantages to partnering with a single contract development and manufacturing organization (CDMO) that offers a complete set of services. As ADCs continue to grab a larger share of clinical pipelines, it becomes…

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…

Industry Perspective: The Financial Benefit of Fully Closed Processing

MilliporeSigma conducted a global market survey on fully closed processing for biopharmaceutical manufacturing and gathered industry viewpoints on the topic. This paper provides key findings from the research, as well as insights and perspectives from industry experts on the shift towards closed processing and its effects on the facility of the future. The future of bioprocessing lies not in isolated, traditional systems but in closed, connected, and continuously enabled processes. This new approach to manufacturing is being leveraged by the…

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…

Development of Advanced Feed Media and Supplements for a Robust, Cost-Effective, and High-Productivity Process

This webcast features: Yaron Silberberg, PhD, Chief Scientist, Ajinomoto CELLiST Korea Co., Inc. Cell culture media composition and upstream bioprocess conditions are crucial factors affecting protein yield in the production of biologics and biosimilars. Recently, advanced new techniques were developed that use IT approaches, including computer simulation of bioprocesses, AI tools, and ‘multiomics’ methods for analysis of cellular metabolic pathways. These techniques allow optimization of both process and media composition for maximizing culture performance and protein production. In this webcast,…