Manufacturing

Whether refitting existing spaces or building new, the need for quick build times, flexibility, and production efficiency is driving trends in bio/pharma facility construction.

Civica Rx plans redundant manufacturing capacity to relieve and prevent shortages of generic, sterile injectable drugs.

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

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.

Thermo Fisher is focused on investing to expand three specific areas of demand: biologics, cell and gene therapy, and drug product development and commercial capabilities.

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

FDA is offering advice and added flexibility to help sponsors adjust ongoing and planned clinical research programs during the COVID-19 outbreak.

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.

The guidance details considerations FDA has set in place to assure the safety of participants while maintaining compliance with good clinical practices and minimizing risks to trial integrity.

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.

Through the agreement, Bora will obtain ownership of the entire Mississauga site, including all facilities, under the proper regulatory clearances.

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.