Dosage Forms

The agency recommends Zalmoxis, a new cell-based therapy to support stem cell transplantation in patients with high-risk blood cancer.

Studying broadly neutralizing antibodies in infants may lead to new pathways in HIV vaccine development.

A research team associated with Dr. Carl June announces it has discovered a way to engineer a patient’s own immune cells to recognize cancer-specific glycoantigens on tumor cells.

A new indication for Emergent BioSolutions’ BioThrax will give the drug market exclusivity through November 2022.

Pfizer broke ground at its Andover, Massachusetts campus on a clinical manufacturing facility for complex biologics and vaccines.

The agency provides quality, development, manufacturing, and labeling recommendations.

Hovione expands drug substance and HPAPI capacity in East Windsor, New Jersey.

A study published in BMJ indicates that rheumatic patients with anti-infliximab antibodies may have a similar cross reaction to infliximab biosimilars.

FDA approved Vaxchora intended for travelers who are at risk for the disease.

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

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

Pharmaceutical Technology sat down with Charles N. Kettler, PhD, director of Natoli Scientific, to discuss the Natoli Institute for Industrial Pharmacy at Long Island University.

The agency reiterated its earlier decision to require suffixes in biosimilar naming, but was unclear on suffix meaning.

Preheating pinch valves prevents drift in the volume of liquid dispensed.

Industry experts discuss the benefits and challenges of using single-use systems in pharmaceutical manufacturing.

With technology advances, continuous manufacturing shows steady progress to more widespread adoption.

Experts discuss the key considerations in the development of an autoinjector.

This article presents recommendations based on a program that was set up to qualify members of a large, diverse team at one oral solid-dosage-form manufacturing facility.

The company expanded its topicals capacity with an investment in the Becomix RW30 model homogenizer.

More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.

The agency publishes draft guidance on assessing the adhesion of transdermal delivery systems and topical patches.

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.

A US government report on advanced manufacturing promotes continuous manufacturing of pharmaceuticals, which has had recent commercial success but faces challenges for widespread adoption.

The company’s method reduces the time required to crystallize antibodies from weeks to one day.

Combining powder micro-dosing services with the Xcelodose technology, Capsugel offers capabilities in both North America and Europe.

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

The GPhA and its Biosimilars Council expressed concern about the new proposed value-based reimbursement rules for Part B medications.

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 production of antibody-drug conjugates requires biopharmaceutical and chemical manufacturing, and conjugation capabilities.

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