Manufacturing

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.

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 135,000 square foot facility will be constructed over 18 months and is expected to be operational in 2021.

WuXi Vaccines, WuXi Biologics’ joint venture with Shanghai Hile Bio-technology, has signed a 20-year vaccine manufacturing contract with a global vaccine leader for $3 billion.

Sanofi will use a recombinant DNA platform that produces a genetic match to proteins found on the surface of COVID-19 to formulate the vaccine.

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 acquisition will bring four new GMP-compliant facilities to the PCI network in the United States, Germany, and Canada.

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.

Consider equipment design, transfer systems, and maintenance when operating isolators for sterile manufacturing of pharmaceutical products.