Manufacturing

Understanding formulation properties early in development can prevent some costly issues later on.

OSD forms are popular within the industry due to the various advantages they offer, but there are specific considerations required to get the best OSD form possible.

This article examines multi-tip tool technology for pharmaceutical tablet compression and the process control and validation issues that must be carefully evaluated to assess the potential for success.

Tools help improve understanding of excipient risk in formulating OSD drugs.

Pre-clinical immunization studies of iBio’s SARS-CoV-2 VLP candidates are being performed by Texas A&M.

AzarGen’s biosimilar, made in iBio’s plant-based system, will be compared to the original molecule in pre-clinical studies.

Bayer, Novartis, Mylan, Teva, report that they are working on supply.

Enhancements to Augury’s AI-based machine health platform include new capabilities and collaboration tools for personnel working remotely.

GEA began supplying the new GEA Hilge Novatwin hygienic twin-screw pump line.

Emergent BioSolutions will help develop and manufacture an oral vaccine candidate and will develop plasma-based antibody therapeutics.

Technologies and methods for new and refurbished manufacturing facility construction expand capacity for new modalities and to ease shortages.

Labeling equipment for primary and secondary packaging and a new label printer improve speed and quality.

The new BIOSTAT STR Generation 3 with BIOBRAIN bioproduction platform offers process intensification with automated feed and bleed and integrated cell retention functionality.

The technology enables the rapid production of large numbers of recombinant antibodies at 80-mL scale.

Understanding of scale-up parameters and use of process analytical technology are important to meet demand for larger batch sizes.

Tackling process development early on can better optimize manufacturing processes for emerging therapies.

The growing interest in developing cell and gene therapies has prompted industry investment to grow manufacturing capacity.

The last year has seen intense investment activity into raising cell and gene therapy manufacturing capacity.

Energy and water waste can be improved with new technologies, and sustainability can be considered in the design of new facilities.

The companies are entering into a development and manufacturing collaboration for the advancement and production of human monoclonal antibodies for the potential treatment of novel coronavirus.

The expansion gives the company diversified capacity running cell production lines featuring Sartorius-brand 2000-L disposable bioreactors and now GE-brand 2000-L single-use bioreactors.

The company presented data on its G2 glycosylation studies at the 15th European Conference on Fungal Genetics in Rome on Feb. 19, 2020.

The partnership will begin in the second half of 2020.

Emerson’s Mimic Field 3D program offers an immersive simulation using a digital twin as an alternative to training on physical equipment.

The company has said that all three of its operating sites in China started back up on Feb. 12 and that it is closely monitoring the outbreak.

Through the agreement, Catalent will offer process optimization and drug substance manufacturing services for the drug candidate at its Madison, WI site.

The Brand Security Platform from ACG Inspection uses blockchain, the Internet of Things, and artificial intelligence technologies to track packages from manufacturer to consumer.

Energy and water waste can be improved with new technologies, and sustainability can be considered in the design of new facilities.

The new facility includes six classified environment rooms with space to expand.

Contract partners must help innovators, especially smaller and virtual companies, consider manufacturability as early as possible in development. This requires focusing on technical and operational performance, as well as cost.