Process Development

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

Models of biopharmaceutical processes can be used for speeding development and improving process control.

Scientific advances open the way to alternatives to animal testing and in-vivo assays.

The benefits of single-use technologies for upstream viral-vector processes clearly outweigh their disadvantages.

The collaboration continues as the companies design bioprocess impurity reagent sets to detect residual HCP from HEK 293 cells.

A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.

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.