Downstream Processing

A thorough knowledge of both the upstream and downstream processes is required to ensure effective removal of residual impurities in biopharmaceuticals.

A simplified downstream process can save time and costs but requires enabling technologies.

Scaling up chromatography resins requires a thorough understanding of their intended use.

Automation enables intensification of downstream processes.

Enriching process understanding enables robust process controls.

Merck has entered into a collaboration with Agilent Technologies with the aim of filling the industry gap in PAT for downstream processing.

Thanks to technological advances, process chromatography challenges are surmountable, but increasingly complex therapies in the pipeline will demand more efficient processes in the future.

An increasingly complex development pipeline and industry considerations, such as sustainability, are leading to a greater need for more efficient separation and purification in downstream processing.

Some progress has been made, but improvements are needed when harvesting cells for cell therapies.

The need to increase efficiency and productivity is driving adoption.

The past year of downstream processing has brought innovations in pH sensitive antibody purification, single-use fermentation separators, and more.

Flexible and efficient methods are needed for biopharmaceutical manufacturing.

Emerging drug classes are giving rise to challenges in downstream processing, pushing the need for strategizing efficiencies.

Enhancement of resin technology can improve the ability of chromatography to purify the growing landscape of increasingly complex biomolecules.

Confounding signals pose challenges to analytical methods necessary for managing residual impurity removal in biotherapeutic manufacturing.

Surrogate analytics are no longer sufficient, as simple inexpensive real-time analytics are urgently needed for high value products.

Process chromatography in downstream processing has seen steady improvements over the years, but there is still room for improvement.

Mechanistic models provide process understanding for developing robust manufacturing processes and for scale up and tech transfer.

Automation is one asset that benefits cell harvesting by cutting out laborious manual steps and minimizing contamination.

Understanding the process and product goals is just the first step to a holistic approach to process development.

New biologic modalities, such as cell and gene therapies, pose increasing difficulties in viral clearance testing methods.

New challenges in extractable and leachable studies for cell and gene therapy products.

GoSilico’s software for digital twins of downstream biopharmaceutical processes will be integrated into Cytiva.

Recent innovations in chromatography resins offer promising advantage in downstream bioprocessing.

As downstream bioprocessing improvements continue, efforts are underway to integrate downstream processes into continuous operations.

Sartorius has expanded in the United Kingdom with the relocation to a new facility in Havant, Hampshire, for downstream processing equipment.

A series of minute virus of mice spiking studies were performed with a monoclonal antibody product and small-scale AEX membrane adsorbers to evaluate a range of critical processing conditions.

The adoption of single-use technologies in fluid-handling systems helps streamline downstream bioprocessing operations.

The need for real-time monitoring and control has spurred the development of new analytical tools.

A unified scale-up approach, as presented here, can be applied to any unit operation.