Process Development

SP Scientific Products’ SP Hull LyoStar 4.0 R&D freeze dryer supports rapid freeze-dry cycle development, optimization, and process scale-up.

What can the biopharma industry learn from its rapid response to the COVID-19 pandemic?

Well-defined studies are crucial to effective process development.

Controlling certain atmospheric conditions in a closed NGI processing chamber can reduce bioburden without disinfectants.

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

Connected, integrated bioprocessing enterprises with greater data analytics capabilities are coming.

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

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 new facility, to be located in Boston, MA, will contain experimental and analytical equipment for viral vector and advanced therapy process development and will expand the CDMO’s manufacturing capacity.

Cell-culture optimization may see benefits from a synthetic biology-based approach that improves product titer, quality, and time.

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

More collaboration and a knowledge-based approach, driven by better analytics and high-throughput system integration, are reducing the risk of failure.

The increased use of single-use bags in biologic manufacturing poses the risk of pinholes and other defects that cannot currently be tested for.

The award will help a bioanalytics startup commercialize instrument technology for pharmaceutical antibody manufacturers.

Process modeling offers an opportunity to troubleshoot for and anticipate difficult aspects of a bioprocess.

The company has begun development of a 3D bioreactor for the cGMP production of extracellular vesicle exosomes.

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

Advanced data analytics, including statistical modeling and machine learning technique, can enable more efficient and reliable bioprocesses.

This latest round of funding adds 14 new technology projects, workforce development, and Global Health Fund projects to NIIMBL's portfolio.

Experience, communication, collaboration, transparency, planning, and prioritization contribute to success.

The new patented process results in uniform, scalable production and the ability to deliver cell cargo similar to natural exosomes/extracellular vesicles.

Better understanding and control of cell behavior is yielding benefits, upstream and beyond.

The trend toward personalized medicines includes more complex manufacturing cycles that can benefit from advanced process modeling early on in the therapeutics’ development.

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

Downstream process development and manufacturing play a crucial role to ensure safety, quality, identity, purity, and efficacy.

In batch production, efficient exception management means reducing the time required to identify, review, and resolve process exceptions. Incorporating review by exception functionality within manufacturing execution system (MES) software can streamline biopharmaceutical product release.

Bob Lenich, Emerson's business director for global life sciences, shares insights on where biopharma modeling is now, and where it is heading in the near future.

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

Manufacturing differences between traditional mAb therapies and newer biotherapeutics dictate whether processes should be scaled up, scaled out, or use an alternate approach for commercial production.

The use of scale-down models allows for the theoretical optimization of processes and for troubleshooting problems during the developmental stage.