Manufacturing

Results of a Phase II clinical trial reveal that stem-cell transplantation treatment following complete immune system destruction increases the duration of long-term remission in patients with multiple sclerosis.

Alvotech prepares for commercial biosimilar production in new facility with single-use bioreactors in Reykjavik, Iceland.

Brammer Bio establishes late-phase development and commercial manufacturing facility for advanced cell and gene therapies in Lexington, MA.

The vaccine alternative, manufactured with a GE FlexFactory system, could be associated with fewer adverse reactions than the live vaccine option

The wearable devices for the delivery of biologic products are now being manufactured and will be tested in clinical trials in the near future, according to the company.

A new 20,000-L microbial biologics facility in Ireland will be operational by 2018 for Fujifilm Diosynth's contract development and manufacturing customers.

The collaboration will provide GMP manufacturing ahead of future clinical studies.

New research presented at the American Society of Clinical Oncology meeting demonstrates that atezolizumab could be a promising first-line therapy for the treatment of bladder cancer in cisplatin-ineligible patients.

A naturally occurring CRISPR (clustered regularly interspaced short palindromic repeats) system that specifically can be used to modify the RNA of an organism is the newest development in the technology’s evolution. A new study, published on June 2, 2016 in Science, identifies C2c2, a bacterial protein that can be used as a tool to cleave single-stranded RNA sequences at desired locations.

Scale-up of complex, innovative products requires commercialization models that are sustainable.

An understanding of continuous process validation can lead the way to consistent approaches, reduced investigation times and observations, the avoidance of lost batches, and high-quality products.

Barriers to the production of biopharmaceuticals in moss are explored.

Advances in single-use systems, consumables, and continuous manufacturing show steady progress.

Advances in cell line engineering, process optimization, and in-vitro glycosylation are making a difference.

FDA and bio/pharma companies get serious about continuous manufacturing to ensure product quality.

A new study in Nature Communications explores how to remove the bulk of the soaps that are added to injectables to make hydrophobic drugs more soluble.

*Updated May 11, 2016Following JHL Biotech’s opening of a FlexFactory flexible manufacturing facility in Hsinchu, Taiwan in 2014, the company opened a second manufacturing location in Wuhan, China on May 10, 2016. According to the company, with the addition of the new Wuhan facility, JHL Biotech will now hold the largest volume of single-use cell-culture capacity in all of Asia.

Phase I clinical trials of PfSPZ revealed it may protect healthy adults, who have not been exposed to Malaria before, for more than on year.

The agency cited Apotheca Supply, a repackager and relabeler of pharmaceuticals for CGMP violations.

The Cell and Gene Therapy Catapult released a review of their third annual survey of GMP cell and gene therapy facilities in the United Kingdom.

Under the terms of an agreement with Pfizer, WAVE will advance up to five programs from discovery through the selection of clinical candidates.

Typical single-use bags and materials cannot withstand a large range of temperatures. Many of the items on the market are associated with extractables that can leach into bioprocessing fluids-an issue that has recently been a topic of conversation among groups that seek to standardize single-use systems, such as the BioPhorum Operations Group (BPOG) and the Bio-Process Systems Alliance (BPSA).

MilliporeSigma expands its Carlsbad, California-based GMP capacity for viral and gene-therapy products by nearly 90%.

Progress is being made, but work remains to be done. Brian Daleiden, vice president of marketing at TraceLink, discusses the state of the industry, as companies attempt to meet complex, and changing, global requirements.

MilliporeSigma, the North American life-sciences business of Germany’s Merck KGaA, added a 2000-L single-use bioreactor to its facility in Massachusetts.

EMD Serono, the North American biopharmaceutical business of Germany’s Merck KGaA, will expand its R&D facility in Massachusetts, US.

Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.

Material compatibility, material sourcing, facility layout, and training are crucial aspects of a successful disposable fill-finish system.

Early successes drive the need to overcome safety issues, increase efficacy, and address manufacturing challenges.

Developers of CAR-T cell therapies with products showing successful early-stage clinical results are currently seeking manufacturing capacity that will enable the production of the larger quantities of material needed for Phase III trials and eventual commercialization.