Thursday, August 13, 2026 – Conference Day 1Thursday, 13 August 2026

• Challenges:
  • Limited infrastructure for advanced bioprocessing.
  • Navigating regulatory complexities for biosimilars and CGT.
• Discussion Points:
  • Role of government policies in fostering innovation.
  • Strategies to overcome cost and scalability barriers.

The transition from cell line development to commercial manufacturing is a critical determinant of biologics success. This talk reframes the production clone as a critical raw material (CRM), emphasizing its central role in ensuring consistent product quality and reliable manufacturing performance.

A structured, risk-based approach to developing a robust, de-risked clone will be presented, with early integration of developability assessments such as stability, productivity, product quality, and scalability. Key strategies to mitigate manufacturing risks—including control of clonal variability, ensuring genetic and phenotypic stability, and alignment with platform processes—will be discussed.

The role of high-throughput screening, predictive scale-down models, and data-driven decision-making in accelerating clone selection while minimizing late-stage failures will also be highlighted. Case-based insights will demonstrate how adopting a CRM mindset for the production clone enables consistent performance and supports reliable, scalable commercial supply.

Reserved for Partners

• Challenges:
  • Variability in feedstock quality affecting cell growth.
  • Scaling up cell culture processes while maintaining consistency.
• Discussion Points:
  • Innovations in cell line engineering (e.g., gene editing, transposons).
  • Best practices for media optimization and bioreactor design.

Reserved for Partners

Protein A chromatography has become the dominant capture step in the downstream purification of monoclonal antibodies and Fc‑fusion proteins because of its exceptional selectivity, robustness, and suitability for platform processes. Primary objective of Protein A capture step is to maximize product recovery while achieving the highest attainable eluate pool concentration. Equally important—though often underappreciated—is the necessity to ensure that the Protein A eluate is intrinsically compatible with subsequent downstream unit operations such as, low‑pH viral inactivation and ion‑exchange chromatography.

This discussion examines the strategic selection and formulation of equilibration, wash, and elution buffers, with particular emphasis on buffer concentrations, ionic strengths and buffering capacities, to consistently achieve both high capture‑step performance and seamless integration with subsequent purification processes.

The impact of rising upstream titres on downstream purification design Next-generation chromatography resins and purification technologies to manage increased product loads

Resin optimization and lifecycle management to maximize capacity and performance Innovations in buffer management to improve efficiency and sustainability

Membrane chromatography and alternative separation technologies redefining downstream throughput

Capacity matching strategies to align downstream operations with intensified upstream processes

Managing impurity profiles in high-titre processes, including aggregates, fragments, and charge variants

Ensuring product quality and process robustness in high-throughput purification workflows.

Reserved for Partners

Analytical strategies in biopharmaceutical development must evolve alongside product understanding, manufacturing maturity, and regulatory expectations. However, development teams often struggle with determining what analytical data are truly needed at different stages of development. Generating extensive analytical data too early can slow development and create unnecessary complexity, while delaying critical frameworks, such as potency strategies or key product characterization, can introduce significant risk later in the program.

This presentation will outline a practical, phase-appropriate approach to analytical strategy across the product lifecycle, from early product understanding through late-stage control strategy. Drawing on development experience across advanced modalities including viral vectors and mRNA platforms, the presentation will illustrate how analytical priorities evolve from exploratory characterization to methods that support manufacturing development, comparability, and regulatory readiness.

Lessons from these modalities will be translated to established biologics and biosimilars, highlighting how thoughtful analytical planning can accelerate development while strengthening product and process understanding.

As CMC expectations grow more stringent, analytical characterization is no longer just confirmatory — it’s strategic. This session will examine how enhanced analytical methods support Chemistry, Manufacturing, and Controls (CMC) justifications, and how analytical insights can de-risk tech transfer and regulatory review. Looking at new technologies such as MAM.

• Multi-Attribute Method (MAM) implementation
• Mass spectrometry advances and applications
• Charge gradient and aggregate characterization

• Discussion Points:
  • Latest advancements in analytical tools (e.g., HPLC, ELISA).
  • Case studies on overcoming analytical challenges in bioprocessing.