Author Archives: Katy McLaughlin

Navigating Diverse Production Challenges: Four Routes to Success

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The biopharmaceutical industry is facing continued pressures to bring high-quality drugs to the market quickly while limiting costs and meeting challenging sustainability targets. However, companies might lack the expertise, resources, and time required to establish, optimize, and scale up tailored, efficient processes that meet market demands. Process consultancy services and preengineered solutions are excellent resources that bring in new perspectives and expertise, regardless of your specific end goals. Here, we outline four key objectives, the challenges associated with meeting them,…

Re-Imagining Chromatography: Navigating the Path to Downstream Intensification

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Global access to medication is a crucial driver in the pharmaceutical industry (1). Thus, drug manufacturers are encouraged to lower their production costs while increasing productivity to bring affordable drugs to market quickly. Process intensification is a natural solution for improving facility output. So far, upstream processes have been the main focus of intensification efforts. Combined with high-performing cell lines, those strategies have created higher titers. However, manufacturers now face bottlenecks in their downstream processes, which must evolve to handle…

October 17, 2023

Designing Single-Use Facilities for Biomanufacturing Expansion

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Minimizing a facility footprint while maximizing manufacturing capacity is essential to staying agile, productive, and cost-effective — all of which are key elements to competing in a dynamic business landscape. To achieve such efficiency at commercial scale, bioprocessing facility design should be tailored to each organization’s specific needs. During scale-up, tailor-designed facility planning is critical to streamlined manufacturing of high-quality products. The size and layout of a space can otherwise become a limiting factor for long-term productivity, revenue, profit, and…

June 26, 2023

Building the Next Generation of Cell-Line–Development Platforms

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Speed to market is a critical business driver in the biopharmaceutical industry. However, drug development success also requires building a robust process that maximizes efficiency while limiting the cost of goods. Achieving time and cost savings without compromising product quality is critical. Development of a productive and stable cell line is the foundation of an efficient and high-performing bioprocess. Cell-line development (CLD) represents some of the most resource-intensive steps within a process development pipeline. Bioprocess scientists must find a balance…

May 17, 2023

Going Big in Cold-Chain Management: Anticipating Challenges and Finding Solutions for Large Volumes

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Bulk drug substances (BDS) often require frozen storage to preserve the integrity of biological material. Cold-chain management is particularly important given recent trends toward increasing globalization and decentralization and diversifying modalities. A secure cold chain is essential for maintaining a product’s critical quality attributes (CQAs) — such as drug product stability, integrity, and purity — and to prevent costly product losses. Scaling Up the Cold Chain Frozen storage at commercial scale presents its own challenges; facilities must be able to…

April 20, 2023

Save Valuable Facility Time with Single-Use TFF

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Biopharmaceutical developers and manufacturers are part of a global, dynamic, and highly competitive market. They face constant pressure to produce high-quality products within relatively short time frames and at reduced costs. Process-intensification strategies and single-use (SU) solutions are popular approaches to maximizing productivity and promoting fast, efficient, and lean processing — the pillars of next-generation facilities. Filtration is an integral part of all bioprocesses and is applied to many up- and downstream steps, including harvest, clarification, and concentration/diafiltration. Tangential-flow filtration…

February 9, 2023

Mind the Gap: Managing Relationships Between Upstream and Downstream Intensification

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Process intensification (PI) describes an integrated framework of strategies to maximize the output of a unit operation, a process, or an entire facility. By implementing PI strategies, biomanufacturers can accomplish their productivity goals by increasing production speeds and titers, reducing facility footprints, and cutting costs. Overall, such changes improve production efficiency and flexibility. Collectively, the biotherapeutic industry has made multiple advancements in intensifying upstream processing. PI strategies include using high-density cell banks, implementing seed-train intensification (n – 1 perfusion), and…

March 16, 2022

Rethinking Chromatography

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Dynamic trends in the biotherapeutic industry are shifting manufacturers towards new modalities and intensified production strategies. This development is supported by ongoing scientific and technical advances in both upstream and downstream processing steps. Downstream processing of new modalities requires chromatography technologies that can handle large, fragile molecules (such as mRNA and viral particles). To maximize speed and productivity, platforms supporting continuous processing will become essential. In this feature, Sartorius discusses current and future concerns for process chromatography operations. They then…

December 13, 2021

Finding the Right Partner for Outsourced Cell-Line Development

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The successful commercialization of a biopharmaceutical product begins with a robust and productive cell line. Inefficient cell-line development (CLD) can lead to costly delays and roadblocks. For that reason, small, new, and virtual companies — and even established and mid-size companies — often seek the support of outsourcing partners to develop their cell lines. Outsourcing CLD activities can ease many pressures associated with manufacturing new biotherapeutics. The benefits of outsourcing CLD and associated processes include access to specialized expertise and…

December 8, 2021

A Strategic Approach to Selecting the Optimal Process Intensification Scenario

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Current demands placed on the biopharmaceutical industry are pushing manufacturers toward process intensification, an approach that modifies unit operations or an entire manufacturing process to optimize efficiency. Three common intensification scenarios in upstream processing are seed-train intensification (usually at the n – 1 stage), concentrated fed-batch production, and dynamic perfusion (at the production bioreactor stage). In downstream processes, intensification strategies typically involve moving from single- to multicolumn chromatography. Biomanufacturers can realize several kinds of improvements from intensified processing, including reductions…

October 28, 2021