Drug Development

Fluid Air’s PolarDry spray dryers use electrostatic technology, providing low-temperature spray drying, encapsulation, and selective agglomeration in the creation of particles.

Capsules offer certain benefits over tablets for oral-solid dosage drugs, and several types of capsules are available.

EMA and FDA guidance encourages design of drug products to improve patient compliance.

This article seeks to promote dialogue among stakeholders to facilitate consensus regarding requirements for excipients.

Instead of rigidly applying statistical tools, experts suggest that pharma embrace statistical thinking, but focus on reducing variability and adding value for patients.

Lawrence Yu, deputy director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), and his FDA colleague, Michael Kopcha highlight the importance of Six Sigma approaches to continuous improvement in the pharmaceutical industry.

The author reviews R&D trends in the pharmaceutical industry, particularly the advancement in biologics drug development.

Omya will be presenting its functionalized calcium carbonate for several applications at the show.

Solid state solutions provider Holodiag and fine chemical R&D provider Holochem join forces.

UPS has revealed a new system to improve drug supply chain security, in compliance with the Drug Supply Chain Security Act (DSCSA).

Additional reactor capacity and a wastewater processing plant increase API manufacturing capacity at the Cambrex site in Kalskoga, Sweden.

ADC Bio announces plans to expand into clinical and commercial drug manufacturing for ADCs.

BASF will build a new specialty amines plant at its existing wholly owned site in Nanjing Chemical Industry Park in China.

Ajinomoto Althea opens manufacturing suites in new high potency and antibody drug conjugate commercial facility.

Support from FDA, a best practice guide, collaborative research, and new facilities signify progress in solid-dosage continuous manufacturing.

By identifying patterns, artificial intelligence and deep learning platforms help researchers discover new drugs faster.

The collaboration with Immunocore, a T cell receptor company, aims to discover and develop immunotherapy molecules to treat infectious diseases.

Kancera’s drug candidate KAND567 will be developed as a capsule formulation for oral administration. Work will be performed at Recipharm’s development facility in Solna, Sweden.

Bayer will use Berkeley Lights’ platform of nanofluidic chips that automate biological workflows, including cell-line development and antibody discovery and engineering.

BARDA has awarded Summit, a drug discovery and development company, a contract worth up to $62 million over five years for the development of a new small-molecule antibiotic.

Scientists at Scripps’ Florida campus showed for the first time that quality control steps exist in the production of proteins, which presents a target for anti-cancer drug development.

Six years after the guidance, it’s time to change our quality assurance vocabulary.

Modeling tools help process engineers optimize a biopharmaceutical facility’s capacity.

Continuous twin-screw granulation offers several options for increasing production scale. Thermo Fisher Scientific explains factors to consider in scale-up projects for manufacturing oral solid-dosage drugs.

Drug repurposing, repositioning, and rescue can be faster, cheaper, and target more diseases than traditional drug discovery approaches.

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.