Formulation and Drug Delivery

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.

Cornell researchers reveal that an existing FDA-approved drug can facilitate the delivery of other large molecules across the blood-brain barrier.

The agency has announced the creation of the Combination Products Policy Council to address issues related to combination products.

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.

Manufacturing highly toxic compounds in a biopharmaceutical environment tests equipment and systems.

Choosing the right container and container closure system is crucial for ensuring product quality, safety, and efficacy of a biologic formulation.

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

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

At DCAT's annual meeting, Bill Downey, president of the market research firm High Tech Business Decisions, summarized results from its latest survey on biopharmaceutical outsourcing.

Industry is joining with academia and global health leaders to examine new approaches to biotech manufacturing.

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

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.

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

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.

During a clinical trial of 48 participants, 100% of those that received the TV003 vaccine were protected from infection.

The author discusses how x-ray spectrometry can be an effective way to measure these impurities and meet regulatory guidelines.

The author discusses key process parameters and shows how a process optimization template can be used to improve this key operation.

The author discusses key areas of focus and presents best practices from the International Pharmaceutical Excipients Council (IPEC).

Asking the right questions is crucial to establishing a biopharmaceutical facility design.

The pharma company revealed in a fourth quarter call that it will improve its cell-culture capabilities by focusing on the use of naïve, highly proliferative cells to manufacture its CAR-T drug candidate.

The author lists five key areas to consider when selecting a CDMO to develop highly potent formulations.

Manufacturing of antibody drug conjugates requires high-containment solutions, such as high-performance aseptic isolators.