Drug Development

When it comes to getting the best out of quality by design, timing is everything.

Considerations in selecting a dosage form for drug delivery to the lungs.

Roquette has completed its previously announced acquisition of Itacel, an excipient division of Blanver.

Pulmonary drug delivery is becoming increasingly used. When developing pulmonary drugs, pharmaceutical chemists must consider drug absorption, control of particle size, suitable toxicology models, and patient compliance. The author reviews the issues specific to developing drugs designed for pulmonary delivery and considers how-with the right knowledge and expertise-these challenges can be overcome.

Informatics software can be used to address the challenges of quality by design, such as managing impurity data when developing an impurity control strategy.

Functionalized calcium carbonate provides high porosity, which enables fast disintegration, and excellent compactibility that results in harder tablets at low compression forces.

Innovative new technologies released over the past several months seek to enhance bio/pharmaceutical development and manufacturing. 

The industry needs a single standard cleaning limit at 25 mg/m2.

MilliporeSigma announced a collaboration with Angiex, a biotechnology start-up, to support the development of Angiex’s lead oncology antibody drug candidate to clinical use.

AstraZeneca and Takeda will partner to develop and commercialize MEDI1341, an alpha-synuclein antibody currently in development as a potential treatment for Parkinson’s disease (PD).

The generic pharmaceuticals firm has sold its Baddi, India formulations manufacturing facility following a recent fire at its joint-venture plant in Algeria.

CDMO Micro-Sphere is investing CHF 21 million (approximately $21.63 million) into the expansion of its GMP manufacturing capabilities at its Swiss facility.

The first program of this collaboration will focus on the development of a candidate for severe acute pancreatitis.

Sensors and communication capability support proper usage, improve compliance, and may enable telemedicine.

Catalent Applied Drug Delivery Institute (CADDI) announced that Jim Spavins, a veteran pharmaceutical industry executive, has joined the institute’s advisory board.

The private investment firm’s $110-million acquisition boosts its API and finished dosage form value chain.

Cambrex is investing $24 Million in new, highly potent API manufacturing capacity at its Charles City, Iowa site.

Featuring software, parallel automated reactors, and other tools designed to facilitate design of experiments, development of the design space, and better process understanding and control, the Hyderabad facility came online on July 20

Lonza further expands its micronization services with the acquisition of Swiss contract manufacturer, Micro-Macinazione, following its previous $5.5-billion acquisition of dosage form provider, Capsugel.

Characterization of the product and process is key for process development and scale-up of topical drug manufacturing using a QbD approach.

Safe and effective drug targeting with ADCs requires careful selection of drug, antibody, and linker. 

Safe and effective drug targeting with ADCs requires careful selection of drug, antibody, and linker.

Systems that discourage continuous improvement threaten pharma innovation, quality, and supply. Can the industry break through this deadlock?

Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.

Lawrence Yu, Deputy Director, Office of Pharmaceutical Quality at FDA’s Center for Drug Evaluation and Research (CDER), shares insights with Pharmaceutical Technology.

The author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.

Statistical methods and novel indices can be used to monitor and benchmark variability, and guide continuous improvement programs in late-stage drug development.

EMA recognizes the need to provide more assistance and guidance to SMEs developing new medicines and applying for marketing authorizations.

The agency is asking for comments on a reflection paper on developing drugs for the needs of older patients.

Horizon to make publicly available its complete annotated CHO cell-line sequence in hopes of driving bioproduction cell-line innovation.