Drug Development

CDMOs have established strategies for handling new chemical entities with unknown biological activity.

The pharmaceutical industry is under tremendous pressure to make drug development faster and cheaper. Applying the right formulation strategy using structured and rigorous science can help avoid costly failures and re-starts, but it’s important to start from an early stage.

Applying the right formulation strategies early in the drug development process can help avoid costly late-stage failures.

Choosing between presterilized and bulk sterilized prefilled syringes.

Tools aid scale-up and comparison of single-use and stainless-steel bioreactors.

Mergers and acquisitions are positive for the CDMO industry, but there is a downside.

The Thermo Scientific Pharma mini implant line is an integrated solution built around the Thermo Scientific Pharma mini HME twin-screw micro compounder.

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.