Downstream Processing

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

CDMOs address the unique challenges of liquid and lyophilized forms as well as preparing for the large capacity needed for COVID-19 vaccines.

The launch of HiScreen Fibro PrismA, the company’s newest product for early mAb purification process development strengthens Cytiva’s new fiber-based Protein A platform.

The development of an innovative purification process simplifies downstream processing for biologics.

Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities.

Continuous SEC was shown to increase productivity with the same product quality and yield.

The latest advances in downstream technologies include sterile disconnects for single-use manufacturing systems, ligand technologies for purifying RNA and for COVID-19 vaccines, and an automated perfusion system.

Rentschler will handle the downstream processing to provide highly purified drug substance at its headquarters in Laupheim, Germany.

A balance must be achieved between debris and impurity removal and maximizing product quality and yield.

As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.

New therapeutics modalities and the need for greater process efficiency are driving technology development.

It is critical to evaluate specific considerations, from design to application, for the benefit of downstream bioprocessing and manufacturing.

Filling and packaging of primary containers is a crucial piece of COVID-19 vaccine production.

Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach.

Tools such as manufacturing execution systems, artificial intelligence, and software innovations are useful for enhancing data integrity protection.

Sartorius adds chromatography systems and resins, tangential flow filtration, and biomolecular characterization technologies.

The latest advances in downstream technologies include a fluid chromatography system, sensing and control units for hygienic valves, a compact valve platform, a membrane purification column, and a protein A affinity chromatography resin.

Ensuring the quality of data in process monitoring and control systems starts in process development phases.

Developers need to transcend the limits of existing separation technologies, to maximize vector recovery while preserving therapeutic potency.

Achieving effective manufacturing processes and sufficient capacity remains a top priority across a diversified biologic drug pipeline.

While cell and gene therapies differ in many ways, some of the best practices for process development and validation are similar.

Temperature-sensitive biologics are lyophilized to preserve therapeutic viability, but the process presents complexities and challenges that are as yet not fully understood.

Ensuring that viral vectors are free of viral contaminants requires a focus on prevention and control.

The new addition will also launch a single-use bioreactor for the 93,000-ft2 facility.

The latest advances in downstream technologies include stainless-steel liquid chromatography columns, sensing and control units for hygienic valves, a wettable phase for separation and purification, a buffer delivery platform, and a new filter integrity tester.

The authors of this study demonstrate an innovative method that is useful and complements traditional HA assays.

The new program, Cornerstone, integrates process development expertise and novel technology to remove development bottlenecks in the manufacture of gene therapy medicinal products.

The editors welcome technical article contributions from biopharma industry experts.

Successful process intensification with inline dilution requires effective monitoring and control.

Higher cell densities are driving innovations in harvesting, including closed systems for intensified processes.