Manufacturing

The agency publishes draft guidance on assay development and validation for immunogenicity testing.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.

Even though the organizers of New York’s Tribeca Film Festival decided not to air the anti-vaccine film by discredited British researcher Andrew Wakefield, the so-called documentary is getting a healthy run and further perpetuating the myth of a link between childhood vaccination and autism.

The authors review the technologies that may help bioprocessing become a truly continuous operation and present case studies that could contribute to the integration of upstream and downstream platforms.

Careful planning, adequate staffing levels, and experienced project managers can help avoid pitfalls of transferring processes from one facility to another.

Solutions to circumvent heterogenous mixtures of antibody-drug conjugates and to ensure uniform drug-to-antibody ratio were discussed at a recent Catalent Applied Drug Delivery Institute symposium.

The draft guidance states information concerning a clinical study of a biosimilar should only be included if it is necessary to demonstrate the safety and efficacy of the drug.

Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing

A modular cell-culture platform demonstrates accelerated process development.

Proven science-based strategies can help to accelerate vaccine development.

The authors provide application data to support the use of SEC beyond small-scale operations.

Risk management takes center stage, and new mobile apps are being developed to help assess global risks in real time.

Global outbreaks energize vaccine R&D and drive production modernization.

Demand is driving expansion and consolidation of formulation and clinical trial materials services.

Industry experts provide insights on the challenges and importance of using buffers in downstream processing.