Friday 21st March - Main Conference Day ThreeFriday, 21 March 2025 - PT (Pacific Time, GMT-08:00)

Knock out (KO) of the BCAT1 gene encoding the first enzyme in the BCAA catabolic pathway reduces accumulation of growth inhibitory short chain fatty acid (SCFA) by-products¹. Some accumulation of these SCFAs, however, allows for robust metabolic shift and higher specific productivities². This talk describes the development of a next-gen process using high-end pH-controlled delivery of glucose (HiPDOG) technology combined with SCFA addition to improve productivity in fed-batch culture.

The growing field of antibody therapeutics is revolutionizing healthcare by offering more precise treatments for various diseases. This advancement demands that pharmaceutical companies efficiently produce high-quality proteins in large volumes. The TheraPRO® CHO Media System, an advanced formulated, chemically defined, and animal component-free media system, meets this need. Designed for ease of use, it maximizes protein production while ensuring high quality compared to leading competitor CHO media systems. It also ensures scalability and consistency across different production scales, enabling a seamless transition from research to commercial manufacturing. This innovation supports the industry’s goal to deliver effective treatments more quickly and reliably.

Innovation to upstream process development has led to higher cell culture titers of biotherapeutics, the increased titer levels have placed a greater challenge to downstream processing to operate more efficiently and reduce cost. To purify increasing amounts of biotherapeutics more efficiently, the use of high flow rates or greater resin-bed heights during downstream chromatography steps is an alluring option. A limitation of increasing chromatography flow rates is the back pressure generated by compression of the packed chromatography resin beds. As chromatography column diameter and resin bed height increases, the resin bed is susceptible to compression that reduces the permeability of the packed resin bed. By providing support of the packed resin bed through control of the hydraulic radius, the permeability of a packed resin bed can be maintained during scale up of the chromatography column. The greater the permeability of a packed resin bed, column pressure-flow dynamics can be improved. Here we introduce OMEGA, a chromatography column insert designed to modulate the hydraulic radius of the column by providing vertical supports through the packed resin bed. Using a commercially available protein A resin, chromatography column performance with and without OMEGA was assessed. OMEGA reduces the effective hydraulic radius of packed columns and increases the permeability of packed resin bed. OMEGA enables higher operational flow rates at increased resin bed height without impact to either dynamic binding capacity or purified product quality. Through the use of OMEGA, scale up hurdles are mitigated, and faster downstream processing times are unlocked across column geometries.

Catriona Crombie, Associate Director for Technology Transfer and Rare Disease Challenge Lead, LifeArc

How it will work is we have 3 Round Tables each covering a different Emerging Innovation in Upstream Bioprocessing. Each will be led by an expert. The expert will kick off and guide the discussion which will last for 30 minutes. At the end of the 30 minutes the leader will report their main conclusions to the room for a maximum of 10 minutes.

Continuous and Intensified Processing

• Transitioning from traditional batch to continuous systems.
• Integration with downstream processes.
• Regulatory acceptance and validation hurdles.
• Development of hybrid systems for phased implementation.
• Advances in perfusion systems and single-use bioreactors.
• Widespread adoption in commercial manufacturing.
• Improved efficiency, reduced costs, and faster time to market.

Automation and AI in Cell Culture

• Resistance to adopting AI-driven systems.
• Lack of data standardization and integration.
• Implementation of user-friendly AI tools with robust training programs.
• Standardized data frameworks and digital transformation strategies.
• Collaboration between tech companies and biopharma.
• Fully automated bioprocessing plants.
• Predictive analytics and AI-driven decision-making becoming mainstream.

Cell Line Engineering Advances

• Genetic stability and regulatory concerns with novel cell lines.
• Slow timelines for new cell line development.
• Limited understanding of long-term impacts of gene editing.
• Use of CRISPR and synthetic biology for targeted, efficient modifications.
• High-throughput screening to accelerate selection.
• Emergence of designer cell lines for specific therapies.

Join Thermo Fisher Scientific to learn the pathway to sustainable manufacturing at Booth #614