Downstream Processing

Advanced LC technologies can streamline the review process for LC equipment maintenance.

The testing of new convecdiff membranes shows this material to be well suited for lab- and commercial-scale bind-and-elute applications.

Affinity chromatography resins must perform well under mild elution conditions yet withstand robust cleaning and sanitization protocols.

Webinar Date/Time: Tue, Jan 24, 2023 11:00 AM EST

The design of viral clearance studies must keep pace with the quickly evolving biologic drugs industry.

Webinar Date/Time: Tue, Dec 6, 2022 11:00 AM EST

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.