Biopharmaceutical Analytics Unveiled: Expert Insights and Customer Success Stories

The global demand for plasmid DNA (pDNA) production is increasing rapidly, driven by advancements in gene therapy. As a crucial component in the synthesis of mRNA, AAV, and other therapeutic vectors, pDNA production requires innovative approaches to enhance yield and purity.

Customer experience highlight:

Ahmet Hilmi Tekin, Senior Operational Scientist at BioNTech Manufacturing Marburg, shares the struggles and successes of establishing a pDNA manufacturing platform. At BioNTech Marburg, a small-scale plasmid DNA manufacturing facility meets the needs of mRNA-based vaccinations for routine use and pandemic preparedness. The PATfix pDNA analysis platform has become a valuable tool in their process development and optimization efforts, enabling rapid insights into every step of their manufacturing process.

Feature demonstration:

The PATfix pDNA analytical platform represents a significant advance in pDNA analysis, offering a seamless solution for monitoring pDNA throughout the entire production process. Unlike other assays, PATfix provides precise measurement of individual pDNA isoform concentrations and tracks pDNA levels in lysate samples, ensuring accuracy at every stage of downstream processing. Additionally, the platform serves as an invaluable tool for optimizing plasmid lysis and controlling linearization reactions.

Key Takeaways:

• Learn about the latest trends and challenges in pDNA production and their impact on the biopharmaceutical industry.
• Discover innovative analytical solutions that provide reliable in-process control for pDNA process development and production.
• Hear from BioNTech Manufacturing Marburg about their experiences and successes using the PATfix platform.
• Engage in an interactive Q&A session to get your questions answered and gain deeper insights into optimizing your pDNA processes.

Production of mRNA involves complex IVT mixtures, including target molecules, process- and product-related impurities, all with similar biophysical characteristics. Designing a correct hardware setup for reproducible analytical separation of these large biomolecules is a significant challenge. In this session, we explore innovative solutions for streamlining mRNA production.

Customer experience highlight:

Michael Daume, Group leader, Downstream Process Development for Nucleic Acids at WACKER Biotech, will discuss how the company develops novel manufacturing technologies and processes for both RNA and DNA manufacturing. These developments require sophisticated and easy-to-use analytical methods, such as HPLC-based techniques. In this presentation, Dr Daume will discuss how WACKER Biotech uses PATfix to gain valuable insights into the development of novel mRNA processes.

Feature demonstration:

In this presentation, we analyze in vitro transcription (IVT) reaction time points, providing insights into reaction kinetics by monitoring critical IVT components. The PATfix software simplifies sample visualization, enabling precise quality assessment and impurity identification. Its wide mRNA linearity range ensures accurate quantification through calibration curves. Additionally, the platform includes methods for polyadenylated mRNA quantification and robust quality control, separating samples by size to reveal abortive transcripts, target size molecules, and double-stranded RNA.

Key Takeaways:

• Understand the complexities of mRNA production and the challenges associated with separating large biomolecules.
• Learn how to accelerate your process development workflows with rapid feedback (5–15 minutes per sample) and user-friendly software for data processing, visualization, and sharing.
• Hear from scientists at WACKER Biotech, who have successfully implemented these solutions to optimize their mRNA production processes.
• Participate in an interactive Q&A session to get your questions answered and gain deeper insights into improving your mRNA production.

Lipid nanoparticles (LNPs) are cell-specific delivery systems capable of encapsulating various payloads, including different nucleic acids. Their characterization proves to be a significant challenge due to their complex composition and structure.

Customer experience highlight:

Dan Peer from Tel Aviv University | NeoVac Ltd. and Tristan Kovacic from Sartorius BIA Separations share challenges and achievements in developing LNP formulations. NeoVac leveraged the PATfix LNP Switcher to enhance the safety and reliability of their LNP-based therapeutics. The system has become an invaluable tool in their process development and optimization efforts, providing quick and comprehensive insights into every step of their LNP formulation process.

Feature demonstration:

The PATfix LNP Switcher offers a unique characterization approach to LNP formulations, addressing the limitations of traditional assays that often require multiple time-consuming steps. Utilizing an innovative 2D chromatographic method with two different separation stages, the PATfix Switcher determines crucial LNP quality attributes in a single run without any sample preparation. Unlike other assays, it allows for simultaneous quantification of both encapsulated and naked nucleic acid cargo, including co-encapsulated species, and provides estimates of mRNA fragmentation and LNP size.

Key Takeaways:

• Understand the key parameters for characterizing LNPs.
• Discover liquid chromatography methods for encapsulation efficiency, lipid composition, load integrity, and size analysis.
• Hear from NeoVac how the PATfix LNP Switcher system has become crucial in enhancing the safety and reliability of LNP formulations by providing comprehensive insights into their development and optimization.
• Participate in an interactive Q&A session to enhance your LNP characterization processes.

Adeno-associated viruses (AAVs) are widely used vectors for gene therapies, due to their safety and high transduction efficiency. With the increasing demand for faster AAV process development, rapid at-line analytical solutions are essential. Join us for the fourth session of our virtual event, where we explore advanced solutions for AAV process development and characterization.

Customer experience highlight:

Shriarjun Shastry, Scientist at North Carolina State University’s Biomanufacturing Training and Education Center (BTEC), emphasizes the importance of analytics in ensuring the quality, safety, and efficacy of AAV vectors in gene therapies. His studies focus on optimizing AAV purification strategies from crude lysates. The PATfix system is employed by BTEC in routine process analytics, offering a comprehensive approach that includes steric exclusion chromatography and size exclusion chromatography for titer analysis, as well as ion exchange chromatography to determine the ratio of empty and full particles. The system’s functionality is enhanced by the support of multiple inline detectors, making it a crucial tool in BTEC’s analytical processes.

Feature demonstration:

This presentation explores the PATfix system’s capabilities for AAV analytics in both upstream and downstream processing, utilizing CIMac analytical columns and various orthogonal methods. The empty/full ratio of AAVs is determined using the AEX-fingerprint method, AAV concentration is measured with the CEX-fingerprint method, and protein impurities are assessed via the SEC-fingerprint method. The AEX-fingerprint method uniquely determines the AAV empty/full ratio from harvest or samples before the capture step, a capability not possible with the other orthogonal methods discussed in the presentation, which require more purified samples for accurate analytics.

Key Takeaways:

• Discover the significance of orthogonal analytics for AAV characterization, including the evaluation of empty-full ratios.
• See how integrated analytical systems with multiple detectors accelerate process development and market delivery of AAV products.
• Learn how scientists at the BTEC have enhanced their AAV production process, improving accuracy and workflow efficiency, and gaining unique insights.
• Engage in an interactive Q&A session to get your questions answered and optimize your AAV workflows.