Take Control of Your Bioprocess Development

Significance of the topic

Upstream bioprocess development demands rapid and data-driven optimization of cell lines and manufacturing protocols. Direct measurement of product quality attributes (PQAs) and culture media characteristics at the point of decision accelerates development, improves therapeutic efficacy, and reduces costly optimization cycles.

Objectives and overview of the study

This whitepaper introduces an integrated solution combining the BioAccord LC-MS System, Sartorius Ambr 15 bioreactors, and Andrew+ automation. The primary objective is to enable process engineers to obtain actionable analytical data within 24 hours, streamline clone selection, and optimize bioprocess parameters with near real-time feedback.

Methods and instrumentation

• BioAccord LC-MS System: A high-throughput, easy-to-operate platform with dedicated workflows for intact mass analysis, subunit analysis, peptide mapping (MAM), released N-glycan profiling, and media component screening.
• Sartorius Ambr 15: Automated microbioreactor platform supporting parallel cultivations (24-48 at 10–15 mL scale) for clone selection, media/feed development, and early-stage process optimization.
• Andrew+ Pipetting Robot with OneLab: Automated sample preparation workflows for concentration normalization, protein cleanup, subunit and glycan analysis, ensuring reproducibility and traceability without specialized programming.

Main results and discussion

The integration of in-lab LC-MS reduces result turnaround from up to four weeks (partner lab analysis) to less than 24 hours. Key performance metrics include a 6-minute intact mass run time with automated data processing and interpretation, comprehensive glycoform and modification profiling, and tracking of titers, identity, purity, and low-molecular-weight variants. Media analysis workflows quantify over 200 components in 20 minutes per sample without additional preparation, achieving sub-ng/mL sensitivity and automated structural elucidation of unknowns. Seamless communication between the LC-MS system and the Ambr 15 ensures continuous feedback and informed decision-making throughout the process.

Benefits and practical applications

• Accelerated decision-making through near real-time analytical feedback.
• Reduced development timelines and operational costs by minimizing iterative optimization.
• Enhanced clone selection and process efficiency based on direct PQA and media data.
• Accessible, user-friendly workflows for non-expert operators.

Future trends and potential applications

• Integration of AI-driven analytics for predictive process control and advanced multi-attribute monitoring.
• Further automation of end-to-end bioprocess platforms linking bioreactor control with inline analytics.
• Expansion of real-time MS monitoring for emerging critical quality attributes and process parameters.
• Adoption in quality control and continuous manufacturing frameworks across biopharmaceutical industries.

Conclusion

The combined workflow leveraging BioAccord LC-MS, Sartorius Ambr 15 bioreactors, and Andrew+ automation empowers rapid, robust, and accessible PQA and media analyses. This integrated approach enables process engineers to make informed decisions, accelerate development timelines, and enhance bioprocess performance and product quality.

Reference

Waters Corporation. BioAccord LC-MS System for Bioprocess Development. Milford, MA, USA; 2022.