Process Development

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.

The partners have developed a scalable, cost-effective purification process for adeno-associated viruses.

A new educational platform by Quality Executive Partners offers on-demand digital courses with technical content, virtual reality, and real-time coaching with an initial focus on sterile product manufacturing and microbiology.

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

The companies aim to integrate glucose sensing with insulin delivery technologies to help change the way diabetes is managed.

The companies plan to create a new curriculum focusing on single-use applications training, cell therapy technology, process efficiency strategies, process development methodologies, and chromatography proficiency.

In an effort to secure a continuous, sustainable supply of an important vaccine ingredient, Agenus is turning to a plant cell-based cell culture method for production.

The evolution of cell-culture technology is driving the need for improvements in modeling solutions.

A collaboration between Insilico Biotechnology and IFAT aims to develop a manufacturing, planning, and control system for the production of monoclonal antibodies.

Now that the first genetically modified cell therapies are being manufactured, the industry must move beyond “whatever works” to meet growing demand.

NIIMBL announced it is partnering with FDA through the University of Delaware to improve biopharmaceutical manufacturing.

In this study, a novel aldo-keto reductase was cloned and purified, and its important conserved sites were analyzed.

MilliporeSigma event scheduled to recognize biotech challenges and support development potential.

Increasingly complex monoclonal antibody molecules will require the right “tool box” for scaling up manufacturing.

Getting the science right helps biopharma startups overcome development and commercialization challenges.

Merck KGaA opened a collaborative bio/pharma development facility in Molsheim, France and announced an investment plan through 2025 for its Darmstadt, Germany headquarters.

The companies aim to assess automated CAR-T cell therapy manufacturing at the point-of-care and develop technologies to facilitate patient access to immunotherapies.

A properly designed validation program will detect variation and ensure control based on process risk.

Teva will apply Insilico’s technology for predictive biomanufacturing to create more efficient biomanufacturing processes.

For rapid scale-up of biomanufacturing under expedited review status, facility design must better integrate product development and manufacturing lifecycle activities.

Kinetic models can be used to study aggregation and fragmentation to help ensure stability.

Advances in single-use technologies, sensors, and cell retention systems facilitate processes designed for the long run.

A multi-purpose biopharmaceutical manufacturing facility using a matrix of multi-functional cleanrooms can be adapted to efficiently meet the capacity challenges of both supplying clinical trials and launching products.

Cobra, Pall, and Cell and Gene Therapy Catapult are collaborating to develop continuous manufacturing for gene therapy production.

The acquisition will allow Lonza to further develop technology for scalable autologous cell-therapy manufacturing.

The companies partnered to build a 500-L single-use pilot-scale plant for biologics production.