In recent years, process development teams have had to continually adapt to evolving therapeutic modalities and process technologies. There has been exponential growth in complex data generation requiring biopharma companies to rethink how they manage that data at scale.

While AI is a hot topic in every industry, the massive potential for impact within biotech - from predictive insights to shortened development times - has resulted in companies racing to unlock the potential, which means structured data is now a strategic imperative. Is your process development organization ready to take advantage of machine learning, LLMs, and advanced analytics?

In this virtual session, we’ll focus on top digital considerations for your process development teams to focus on as you enter this next wave of innovation. Key topics include:

• Establishing data models that support new modalities, evolving science and align with industry standards (ISA88)
• Leveraging integrations across instruments and systems to automate data capture
• Structuring and standardizing data across R&D teams to ensure data is findable, accessible and interoperable
• Making data AI and ML ready

Speakers:

Michael Schwartz
Product Specialist, Process Development
Benchling

Justin De La Cruz, Ph.D.
Solutions Consultant, Process Development
Benchling

Pharma and life sciences manufacturing is among the most sophisticated in terms of the resulting products and complexity of processes. Advances in computing have helped to drive the life sciences revolution and generate enormous amounts of useful manufacturing data. With strong leadership these advances offer a means of constant process improvement, mitigates complexity, and enhances profitability. This example driven session will describe how a modelling and data driven culture can be developed, the resulting benefits, and how to avoid pitfalls.

Speaker:

Joseph Pekny
Professor
Purdue University

The Biopharmaceuticals R&D Cell Therapy Department holds the ambition of developing and delivering Cell Therapies to address Cardiovascular, Renal, Metabolic, Respiratory and Immunological diseases. With focus on ex-vivo manipulation of cells, the department works cross-functionally both internally and externally to deliver therapeutic candidates - while building innovative manufacturing solutions to achieve clinical realization. At the end of this webcast, the attendees will have acquired knowledge on the initial design and build of process development platforms in a large biopharma setting and will learn about the scalable manufacturing workflows for cell therapies.

Speaker:

Tania Incitti
Associate Principal Scientist
Astrazeneca

A variety of parvovirus removal filters having unique membrane structures and chemistries are commercially available. However, some filters show performance characteristics such as rapid fouling, reduced flux and virus breakthrough when faced with variable feed stream conditions and others achieve high flux but tend to foul quickly. The recent push for process intensification requires the capability to reach high capacity, either by high throughput or extended run duration, without fouling or flux decay. The recently launched Planova S20N filter was specifically designed to improve operational efficiency and flexibility by providing higher throughput, robust virus removal capability and stable protein filterability. We will present the characteristics and results of customer-led and internal evaluations on Planova S20N filters, including studies related to continuous processing. We will show how Planova S20N is up to the challenge of providing viral safety in virtually any biologic manufacturing process.

Speaker:

Christine Stouffer
Senior Research Associate
Asahi Kasei Bioprocess America, Inc.

High-performance biomanufacturing processes are needed to accelerate the time-to-market of safe and efficient drugs. Finding raw materials to allow the production of safe drugs is crucial to ensure efficient processes.

Trypsin and Insulin are key ingredients used in pharmaceutical bioprocessing. Trypsin enhances virus activation in adherent cell-based viral vaccine production, while insulin promotes cell proliferation and productivity. Novo Nordisk Pharmatech’s TrypsiNNex® and Recombinant Insulin are high-purity, recombinantly produced animal-free raw materials, enabling a more robust production and reducing the risk for contamination.

TrypsiNNex® is expressed and kept in an inactive form until stabilization resulting in a high and consistent proportion of β-trypsin. This makes it ideal for virus-vaccine production.

By activating cell proliferation and productivity in a wide range of different cell types, Recombinant Insulin is a key ingredient in serum-free cell culture media for vaccine, mAbs, and cell therapy development.

We will describe how TrypsiNNex® and Recombinant Insulin can improve process efficiency, thanks to their unique properties.

Speakers:

Sara Bursomanno, PhD
Global Product Manager
Novo Nordisk Pharmatech A/S

Marie-Louise Lunn, PhD
Global Product Manager
Novo Nordisk Pharmatech A/S

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 molecule formats.

Their unique strength lies in the combination of their extensive commercial expertise and development capabilities. This enables them to provide the complete value chain, from early stages to launch and commercial supplies, for microbial derived biopharmaceuticals.

Discover how they can help drive your biologic breakthroughs towards a healthier future.

Speakers:

Athelney Woolnough
Director Business Development/Key Account Management BioXcellence
Boehringer Ingelheim

Franz Schuster
Strategy Implementation Manager Biopharma Austria
Boehringer Ingelheim

Nikolaus Hammerschmidt
PhD, Head of Unit Downstream Development, Process Science RCV Vienna
Boehringer Ingelheim

During the early phase of biopharmaceutical process development, it is of great importance to understand the behavior of impurities. As the process development generates more samples and knowledge through broad and targeted screening, a fast, sensitive, and robust method is needed to measure product quality, such as HCPs. We use the Gyrolab platform to understand our processes in terms of HCPs as early as possible. For this purpose, we have developed a generic workflow to quantify HCPs in different units (Process Development and Quality Control) using various methods (Gyrolab, Mass spectrometry, and ELISA) from process development to production scale. The procedure, in particular our experience with the Gyrolab platform and comparative measurements, will be presented in the talk.

Speaker:

Martin Voigtmann
Senior Scientist Analytical Development
Boehringer Ingelheim RCV GmbH & Co KG

How to amplify downstream processing efficiency of viral vectors, extracellular vesicles, and nucleic acid targets with next-generation nanofiber technology. This webcast will cover development of strategies to address the rapidly expanding pipeline of complex and diverse modalities that are currently challenging for cell and gene therapy. We will look at how you can achieve intensified productivity through an integrated approach that combines disruptive technologies with existing single-use infrastructures.

Speaker:

Marc Hummersone
Senior Director, R&D
 Astrea Bioseparations

This session will dissect the biosynthetic bottlenecks affecting manufacture of next generation biopharmaceuticals and introduce methods to overcome them. Using examples spanning mRNA, protein, cell and AAV product-formats, I will discuss why “difficult” molecules fail, and how we can create purpose-built manufacturing platforms from the ground up by designing optimized cell factories, expression vectors and culture media formulations.

Speaker:

Adam J Brown
Associate Professor of Biopharmaceutical Engineering, CTO
University of Sheffield