Thursday 18th September - Main Conference Day ThreeThursday, 18 September 2025 - ET (Eastern Time, GMT-05:00)

This talk will focus on the steps and procedures necessary to produce a drug product, starting with a biologic drug substance. This is the final step in drug manufacture and the only set of procedures that must be done aseptically. The typical testing procedures for drug product will also be discussed.

• Prioritising strategic value and technological fit over cost.
• Moving from contract oversight to building true strategic alliances and relationships.
• Leveraging CDMOs to access innovation.
• Integration for Speed: Aligning partnerships to directly accelerate development timelines and time to market.

This presentation outlines a systematic, data-driven framework for evaluating the developability of biologic therapeutics, with emphasis on pre-formulation. An IgG1 monoclonal antibody case study demonstrates key methodologies, including in silico stability profiling, forced degradation, formulation screening via DoE, and predictive modeling, to support early risk assessment and formulation strategy development.

This poster presents a customized mass spectrometry approach for sub-ppm quantitation of high-risk host cell proteins (HCPs) considered critical quality attributes. Enhancements to standard HCP-MS workflows enable sensitive detection of immunogenic or enzymatic HCPs. DnaK is used as a model to demonstrate method specificity and performance.

Join us for an enlightening session where corporate professionals and industry leaders share insights about diverse scientific career paths that students may not have previously considered.

• Discover Hidden Career Paths: Explore science roles beyond the lab and academia.
• From Research to Real-World Impact: See how scientific work drives innovation in corporate and global contexts.
• Education & Skills Roadmap: Learn the pathways and skills needed to enter and thrive in science-based industries.
• Growth & Leadership: Understand how technical roles can evolve into management and executive opportunities.
• Networking that Works: Hear how mentors and professional connections shape long-term career success.
• Future Trends: Get a look at emerging fields and where science careers are headed next.

We present the automated Cloning Platform using microfluidic GRIDs for efficient hiPSC genome editing. By leveraging interfacial tension and optical clarity, single cells are cultured in traceable nanoliter chambers. The platform delivers high cloning efficiency, reduced workflow complexity, and robust maintenance of pluripotency in genome-engineered hiPSC clones.

• Regulatory standards – 21 CFR Parts 210 and 211
• Quality Agreement development and Implementation
• Supplier Qualification and Audit – risk based approach - paperbased vs. on onsite
• Compliance and lifecycle Management
• Audit Readiness
• Q&A

We developed a fully single-use, animal-component-free platform for commercial-scale plasmid DNA production critical for rAAV manufacturing. Our process begins with systematic clone screening to verify plasmid integrity and optimize yields. Clones undergo extensive characterization including viability, plasmid retention, and ITR integrity assessments. Using single-use bioreactors (3L-50L), we achieved robust scalability through optimized media and process parameters. The platform accommodates various rAAV-related constructs. Downstream purification combines optimized cell lysis, filtration, and chromatography, yielding high-quality supercoiled plasmids with minimal impurities. Comprehensive analytics confirm quality attributes, with consistent rAAV yields from 250mL to 1000L scale.

This presentation explores Taylor & Francis Group's comprehensive approach to knowledge dissemination through author-publisher collaboration. We examine how the publishing ecosystem facilitates the transformation of ideas into impactful publications across academic, professional, and practitioner domains. The discussion highlights our streamlined proposal-to-publication pathway, emphasizing personalized author support services designed to maximize scholarly impact. Special attention is given to our innovative Focus Shortform Book Program, which addresses the growing demand for rapid-response publishing in emerging fields. Through case examples and process analysis, we demonstrate how strategic publishing partnerships create accessible knowledge platforms that advance disciplinary conversations and practical applications across global knowledge communities.

Adeno-associated viruses (AAVs) are leading vectors for gene delivery, yet current chromatographic tools face limitations including incomplete serotype coverage, low yields, short lifetimes, and harsh elution conditions. ChromaGenix has developed the first serotype-agnostic affinity resin for AAV purification, offering broad coverage, mild elution, high recovery, and extended lifetime for cost-efficient, scalable processes.

Subcutaneous delivery of biologics via self-dosing devices is increasingly essential for chronic disease management, yet development remains slow and costly—often requiring years and tens of millions of dollars due to formulation redevelopment and complex clinical trials. A key barrier is the disconnect between drug and device development, regulated under separate frameworks (21 CFR 210/211 vs. 820). This talk introduces an integrated approach for drug and device development from project inception to commercial launch and provide effective toolboxes along the development phases.

Group discussions focused on specific challenges in CDMO selection, such as:

• Phase-appropriate CDMO selection & finding CDMOs with niche capabilities (e.g., specific cell lines, advanced therapies).
• Balancing cost, quality, and timelines in the selection process.
• Building trust and transparency in the initial stages of partnership.

Discuss and feedback to the group