Dosage Forms

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

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.

The agency found no differences in risk of pneumonia for different products.

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.

FDA approved an update in the manufacturing of Prezista (darunavir) using a continuous manufacturing line at Janssen Supply Chain’s facility in Puerto Rico.

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

Texture analyzers can be used to evaluate wall hardness and elasticity of softgel capsules.

Consider the 3 Ps (product, process, and patient) when choosing a parenteral packaging material.

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.

Industry experts and FDA’s Office of Pharmaceutical Quality discuss the challenges, trends, and regulations involved in ensuring quality in solid and semi-solid dosage forms.

Pharmaceutical Technology spoke with Bill Randolph, vice-president, Technical Services, Janssen Supply Chain, about some of the considerations for technology transfer of a continuous, solid-dosage manufacturing process and what he sees as the outlook for continuous manufacturing.

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

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

Pharmaceutical Technology spoke with FDA to get the agency’s insights on how the industry can ensure quality in solid and semi-solid dosage products.

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

Wear-resistant materials and coatings protect tablet punches and dies from abrasive formulations.

The syriQ Rigid Cap (SRC) and SCHOTT TopPac Rigid Cap (TRC) closure systems from Schott use an intuitive twist-off mechanism for ease of use and container closure integrity.

Hovione will operate a commercial-scale continuous manufacturing facility in New Jersey as part of an agreement with Vertex Pharmaceuticals.