Manufacturing

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The draft guidance states information concerning a clinical study of a biosimilar should only be included if it is necessary to demonstrate the safety and efficacy of the drug.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

Headspace moisture analysis is a rapid non-destructive analytical method that may potentially address the limitations of traditional methods used for residual moisture determination.

Although many immunotherapies focus on tumor-associated antigens, many of the peptide targets on the surface of cells have not be validated.

Adheren relies on chemical modifications, rather than genetic engineering, to create its cell-based immunotherapies.

The companies will provide assays for functional comparability, for use in quality control, lot release, and stability testing of biosimilars and biobetters.

A team of Bristol-Myers Squibb scientists will work in a new laboratory at the National Institute of Bioprocessing Research and Training facility in Dublin, Ireland.

Novo Nordisk broke ground on a facility in Clayton, NC, to manufacture APIs for GLP-1 and insulin medicines.

Collaboration will provide for unified development and manufacture of antibody drug conjugates.

The BARDA-supported monoclonal antibody was approved both as a treatment after anthrax exposure and as an anthrax prophylactic.

The Human Vaccines Project brings together academic research centers, industrial partners, nonprofit organizations, and governments to address the primary scientific barriers to developing new vaccines and immunotherapies.