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BioSolve Process Web Workshop

Thank you to all those who attended our July Webinar. Due to requests from some clients, we decided to run the repeat of the sessions in September.

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Speakers

Biography:

Jochen B. Sieck, PhD, MBA
Merck KGaA, Darmstadt, Germany

Jochen is an experienced mammalian cell culture process developer. After his Diploma in Biotechnology, he joined Novartis Bioprocess R&D, working on the scale-up and scale down of bioprocesses.

After receiving his PhD in bioprocess engineering from ETH Zurich, he worked for Novartis as a Postdoc working on establishing a new perfusion platform, which included some exposure to BioSolve.

He joined Merck KGaA, Darmstadt, Germany in 2014 as cell culture media R&D manager. The focus of his team is cell culture media development for perfusion applications, but they are also involved in developing integrated upstream solutions beyond cell culture media.

He received an MBA in Innovation and Technology Management in 2018. Now a senior R&D manager, Jochen is also involved in various corporate innovation initiatives, like continuous bioprocessing and media development for cultured meat.

Title: Economies of Scale: Key Drivers for Cultured Meat Manufacturing

Abstract: The potential of cultured meat to realize positive environmental impacts heavily depends on both technological and economical issues that need addressing. It is critical for the industry to understand the most influential cost drivers, such that innovation efforts can be focused to those areas.

Our experience as a cell culture media supplier to the biopharma industry informs that the impact of media cost on process economics is sometimes overestimated. On the other hand, the costs involved in building and operating a cell culture manufacturing facility are often underestimated.

In this project we applied a commercial software package to evaluate the cost structure and cost contributors for cultured meat processes. Several assumptions and estimations were made about bioreactor types and scales, as there are currently no exemplar commercial scale processes in operation.

In addition, we limited the scope to proven technologies and equipment applied in biopharmaceutical cell culture processes today.

The relative impact of single cell suspension, microcarrier culture, or hollow fiber bioreactors on the economics of the proliferation stage was compared. This was followed by a sensitivity analysis to determine the most influential process variables.

We will discuss which culture modality has the highest potential to scale from an economic point of view.

Furthermore, sensitivity analysis revealed the impact media performance (i.e. cell yield per liter medium) will have on process economics, compared to media cost. Results indicate that, to realize industrialization of cultured meat, the industry must accomplish early development steps previously taken by biopharma, including developing robust cell lines and serum-free, chemically defined media.

However, more and faster innovation cycles will be needed than were gained in the biopharma industry over the last decades, for cultured meat to become a viable alternative to conventional products.

Biography:

Niklas Jungnelius
Process Modeling Leader, Cytiva, Uppsala, Sweden

Niklas Jungnelius is Process Modeling Leader for Bioprocess products at Cytiva. In this role, he manages Cytiva’s internal as well as external activities in bioprocess modelling.

Niklas holds a Master of Science in Chemical Engineering from Chalmers University of Technology and has over 20 years of experience from various companies and positions in the life science industry.

Over the last 9 years, Niklas has held different strategic positions at Cytiva/GE Healthcare, contributing his expertise to areas such as biomolecule purification technology, process economics and pricing.

Title: Single-Use and Sustainability

Abstract: Environmental sustainability is a complex and increasingly important aspect of biopharmaceutical production.

This presentation will highlight various considerations in assessing environmental sustainability.

Further, it will discuss the Life Cycle Assessment (LCA) concept and findings from Cytiva’s LCA to compare environmental impact from traditional, SU and hybrid processes at various process scales in different geographical locations.

Internal Speakers:

Biography:

Adriana has over nine years’ experience in the biopharmaceutical industry in both process development and GMP manufacturing operations.

She has lead optimisation and scale-up/down, technology transfer projects, and managed feasibility and implementation projects.

Adriana has worked with a range of product types such as vaccines, recombinant proteins and antibodies at different stages of the product lifecycle.

She is responsible for modelling new novel technologies and processes, and manages external academic collaborations to support the future development of the BioSolve platform. Adriana holds an MSc and EngD in Biochemical Engineering from UCL.

Title: Cost Analysis of CAR-T Cell Therapy manufacturing and supply chain

Abstract: A cost model was described using Biosolve to measure the impact of automation and scale-out of a CAR-T manufacturing process, and associated supply chain.

The partially automated CAR-T manufacturing process was the most economical configuration by CoGs analysis. However, after scale-out and inclusion of the impact of time by NPC evaluation, the manual CAR-T process became the most cost-effective option to meet an annual demand of 5,000 patients.

Key process cost drivers were identified as the viral vector required to introduce CARs into T-cells and QC tests.

A sensitivity analysis was undertaken to aid a manufacturer on whether to produce or undertake the latter in-house or outsource.

Local and centralized CAR-T supply chain models to treat a peak demand of 5,000 patients were also compared.

The cost of treatment to the patient, including supply chain costs, was estimated to be between $78k $93k.

A sensitivity analysis of the supply chain models showed the impact of resource availability, patient demand and lengthening the bottleneck on estimated costs.

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