Formulation and Drug Delivery

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.

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

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.

The authors evaluated the performance and robustness of controlled-release tablets made with HPMC blends of unimodal and bimodal molecular weight distribution.

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The agency publishes draft guidance on assessing the adhesion of transdermal delivery systems and topical patches.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

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%.

Safe handling of HPAPIs requires determining exposure potential and selecting appro-priate containment strategies.

Experts discuss some of the emerging trends in bioprocessing in 2016, including 4D bioprinting, 2D-NMR, and the CAR-T design space.

Bioprocess operations-from cell line selection to final filtration-can influence the consistency and purity of biologic drug substances.

Policies for patient access to life-saving therapies must keep pace with biomedical innovation.

Application for Sirdupla Uniformity of Delivered Dose Methodology

Armin Gerhardt, associate professor of Pharmaceutical Science, Concordia University Wisconsin School of Pharmacy, discusses the effects of moisture on product quality and how to achieve good control of moisture during pharmaceutical manufacturing operations.

Immuno-oncology drugs are demonstrating patient benefits, but growing resistance to the high cost has implications for patients, market access, and manufacturers.

The company announced the launch of its first-in-class Lynx CDR connectors at INTERPHEX 2016.

Highly potent or cytotoxic drugs require special handling

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.

Linker technology and drug combinations play an important role in the efficacy of ADCs.

The Office of Generic Drugs highlights the agency’s work to advance generic drugs.