From Quantification to Characterization: How Analytics Drives Efficient Cell Line Development

Cell Line Development (CLD) is essential in the journey to groundbreaking therapeutic products. Early integration of advanced analytics significantly improves the precision and efficiency of selecting optimal cell lines. Accurately verifying attributes like titer earlier in CLD can accelerate the developmental timeline and reduce costs.

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Rapid IgG Quantification in Cell Culture Supernatant

CLD researchers have grappled with the time-consuming and labor-intensive process of identifying high-producing cell lines and selecting the best candidate for further development of therapeutic antibodies. Production efficiency hinges on selecting cell lines that exhibit robust antibody expression. Traditionally, IgG quantification has posed significant challenges:

• Labor-intensive process - The process can take hours or even days to produce results

• High complexity and cost - Screening hundreds or thousands of clones slows timelines and increases cost

• Bottlenecks in scalability - Manual or slow processes impact high-throughput screening needed for commercial viability

To address these challenges, laboratories require a faster and more efficient approach to IgG quantification. Leaning on the innovative IgG quantification tools, like the Beckman Coulter Life Sciences Valita Titer Assays, offers a solution.

• Automation and high-throughput - Ideal for large-scale screening efforts

• Rapid results - Reduces the time required to assess IgG titer to just minutes.

• Simple workflow - Involves a simple “add, mix and read” process

• Significant efficiency gains - Rapid identification of high-producing cell lines, streamlining development timelines

The Valita Titer Assay advances IgG quantification and supports the rapid identification of cell lines for therapeutic antibody production.

We see a way to fully characterize intact proteins 95% faster

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We see a way to accelerate the CLD clone picking process by 8X and reduce waste by 50%.

Fast-Track Protein Characterization and Quantification

Monoclonal antibodies (mAbs) are a crucial class of biotherapeutics due to their high specificity, efficacy and adaptability for treating various diseases. However, enzymatic cleavage and chemical post-translational modifications (PTMs) during manufacturing introduce charge variants, which can considerably influence the properties of mAbs both in vitro and in vivo. Therefore, characterizing charged heterogeneity is essential for assessing critical quality attributes (COAs). Key points include:

Impact of charged variants

• Affect antibody binding, tissue penetration, distribution and antibody pharmacokinetics

• Can compromise efficacy, safety or stability if not properly controlled

Critical Quality Attributes

• Encompass a spectrum of properties that must adhere to predefined limits or ranges

• Ensures the final therapeutic product meets the required quality standards, ensuring safety, efficacy and potency

Imagined Capillary Isoelectric Focusing (icIEF)

• Offers a high-resolution separation of protein charge variants

• Effectively differentiates variants with similar isoelectric points

• Widely used to monitor CQAs and product quality attributes

Challenges in PTM characterization

• Traditionally requires multiple advanced analytical techniques

• Involves time-consuming workflows, often taking several weeks

Intabio ZT system

• Enables direct coupling of icIEF charge variant analysis, UV quantitation and high-resolution mass spectrometry (MS)

• Facilitates confident identification of intact proteins

• Streamlines workflow, reducing the time to results from weeks to about one hour for routine samples

• Offers significant advantages over ion exchange chromatography with fraction collection

The careful selection of cell lines significantly shapes the later phases of development, ensuring the quality and efficacy of the end products. A finely tuned CLD process consistently generates pre-qualified, high-yielding cell lines and streamlines the selection process. These innovations provide early detection of unsuitable cell lines, enhancing manufacturing efficiency by reducing waste and operational costs while accelerating time to market.

To learn more about our analytical solutions or explore ways of partnering with us, contact an expert from the Life Sciences companies of Danaher today.