The evolution of therapeutic modalities drives the adoption of single-use technologies.
Despite a growing number of biosimilar approvals, market uptake remains a challenge.
Given the criticality of fill/finish processes, it is clear that automation is the next technological step.
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.
Two main safety issues have been identified in the early-phase clinical trials conducted to date for chimeric antigen receptor (CAR)-T cell therapies.
Cell therapy companies are attracting interest from investors, and drug companies are seeking partnerships and acquistions to accelerate development.
The company announced the launch of its first-in-class Lynx CDR connectors at INTERPHEX 2016.
The agency publishes draft guidance on assay development and validation for immunogenicity testing.
The Subcommittee for Advanced Manufacturing of the National Science and Technology Council highlights biopharmaceutical manufacturing as an emerging priority.
Traditional methods of measuring the effectiveness of vaccines against the flu are called into question by new findings from the NIH.
Shire announces plans to build a flexible biopharmaceutical manufacturing facility in County Meath, Ireland.
Linker technology and drug combinations play an important role in the efficacy of ADCs.
The National Institute of Health will conduct an internal review of the National Cancer Institute’s cell manufacturing facilities, which will affect multiple Kite projects.
FDA explains the rewards that may be associated with switching from batch to continuous manufacturing.
A report by Reuters found that four of the top 10 most widely used drugs increased 100% since 2011, while the other six increased 60%.
FDA added warning labels to medications containing saxagliptin and alogliptin after clinical trials linked the drugs to increased risk of hospitalization for heart failure.
Inflectra is the second biosimilar to hit the market in the United States.
The agency has announced the creation of the Combination Products Policy Council to address issues related to combination products.
Microchannels show potential benefits for inertial cell sorting and for introducing genetic material into cells.
