Wednesday 19th March - Main Conference Day OneWednesday, 19 March 2025 - PT (Pacific Time, GMT-08:00)

• Accelerated clinical process development and CMC timeline
• Downstream process characterization workflow and case study
• Approach on Tier 1 and Tier 2 process characterization to enable PPQ and BLA
• Control strategy platform development for robust manufacturing
• Modelling consideration on future process characterization

• Signal peptides have an important role in modulating protein biogenesis, and they can significantly impact the
  efficacy, stability, and yield of therapeutic proteins.
  
  
• Every protein in the secretory pathway has a unique pool of high-performing signal peptides. Latest
  technological advances allow analyzing them in thousands to find the best performing signal peptide-protein
  combination.
  
• Examples presented will show how engineering of signal peptides lead up to 5X in expression without
  compromising protein quality.

We present a novel pilot-scale benchtop system that can run almost all major downstream purification processes, such as chromatography, tangential flow filtration (TFF), SPTFF, normal flow filtration, inline dilution, and various process intensifications (4C) and integrated processes. This platform features its powerful multi functionality with three key innovative process configurations and modular concept as well as a comprehensive industrial DCS control and data management framework in line with digital transformation. The system represents a transformative shift in bio pharmaceutical downstream processing and can play a critical POC role for tech transfer.

The biopharmaceutical industry faces increasing pressure to produce a wide range of therapeutics quickly, with high yields and consistent quality. Lonza helps companies meet these demands with integrated solutions that streamline the entire drug development process. By combining cutting-edge expression technology, efficient CHO media systems, and expert biologics services, we support drug developers and producers from late-stage discovery all the way to commercial supply.

At the core of our solutions is the proven GS® platform, designed to deliver high-yield, scalable, and stable expression for a broad range of biotherapeutics. With this platform, we help you optimize the expression of your molecule, whatever its type, helping to reduce time to market.

Supporting this, the TheraPRO® CHO Media System offers a chemically defined, non-animal origin (NAO) formulation, solution engineered to maximize protein yield and ensure scalability across research and manufacturing stages. Its advanced formulation delivers consistent performance and simplifies workflows, backed by proven performance for modern bioprocessing needs.

Lonza’s biologics services further offer end-to-end solutions for any molecule type. These services encompass drug candidate selection & optimization, process development, clinical and commercial manufacturing, and regulatory support, helping customers reach the clinic and market faster.

In this talk, we'll cover how our proven GS® platform, CHO media, and expertise in biologics enable biopharmaceutical companies to efficiently bring scalable, high-quality therapies to market, transforming scientific innovation into life-changing treatments for patients.

High-performance liquid chromatography (LC) and mass spectrometry (MS) are proven tools for the analysis of critical process parameters (CPP) and critical quality attributes (CQA) of biotherapeutics. Historically, LC-MS has been performed off-line – a process that can take days or weeks to complete. By moving LC-MS to the manufacturing floor as an on-line Process Analytical Technology (PAT) tool, relevant data can be accessed in a matter of minutes. In this presentation, we highlight an initial use case, demonstrating the utility of LC-MS to monitor and control antibody CQAs in bioprocessing. The implementation of PAT enables continuous manufacturing and empowers industry progress towards Bioprocessing 4.0.

• How CDMOs have evolved in the last 5 years and what to expect in the coming years;
• Geopolitical uncertainty and its impact on outsourced manufacturing;
• Collaboration to understand the changing needs of pharma and biotech.

• The general trend towards external manufacturing sites for mammalian-derived biopharmaceuticals requires a seamless and efficient tech transfer concept.
• This concept needs to ensure fast scale up and market supply while maintaining high quality standards and reliable processes.
• With Lonza’s strong track record in tech transfers, this session will focus on key strategies and success factors to overcome common challenges during late stage tech transfers.
• We will also share how to maintain a high standardization within a global mammalian manufacturing network, how to leverage the Lonza expertise across the globe, and how to create a streamlined road to success within each individual site.

Depth filters are widely used in the biopharmaceutical industry. They are typically made of a mixture of cellulose, filter aids, and a binder. These components can be milled and mixed in different ratios to target a wide range of pore sizes. The complex nature of the raw materials gives each filter a relatively broad pore size distribution and provides some adsorptive capacity through charge and hydrophobic interactions. The filter media thickness, pore size distribution, and adsorptive capacity make them the ‘go-to’ technology in harvest applications where a product is separated from a complex cell culture fluid.

Recent work has highlighted the importance of how flow distributes within single-use capsules, and how capsule design can affect scalability. In this work, we take a deep dive into flow distribution through depth filter capsules using a combination of CFD modeling and experimental work. CHO cell culture streams, both direct and post-centrifugation, are used to assess performance parameters such as capacity, impurity removal, and yield. We will also present scalability data across a full range of process development-scale, pilot-scale, and manufacturing-scale depth filter capsules. This data will help process development scientists and engineers understand the structure of these devices, what parameters to focus on during development, and how to set appropriate safety factors during scale-up.

Novel modalities propose unique challenges for their purification and removal of impurities - how can purification processes be optimized for these novel modalities?

• Downstream processing considerations for modalities such RNA-based-therapies, T-cell engagers, CGTs.
• Key challenges in purification, scaling, and quality control.
• Innovative solutions and strategies for optimizing these processes.