Drug Development

Industrial-scale continuous API manufacturing may offer cost and safety benefits.

New ADC therapies must overcome manufacturing challenges to reach market.

As pharma models changed during the past 40 years, contract manufacturing capacity and services evolved to meet demand.

The more pharma science and technology change, the more business and policy concerns stay the same.

Polymers and surfactants impact stability and long-term performance.

Excipients play a key role in the development in emerging dosage forms but attention to quality is crucial.

Drug costs, biosimilars, and cloud-based technologies will shape the pharmaceutical industry in the years to come.

Pharma’s test of continuous manufacturing is starting with oral solid-dosage forms.

FDA’s process validation guidance has evolved and the current lifecycle approach has profoundly influenced validation practice.

The agency announced a plan to eliminate its existing orphan designation request backlog.

BASF plans to build a new world-scale ibuprofen production plant in Ludwigshafen and expand ibuprofen capacities at its Bishop, Texas plant.

The patent was filed for a chewing gum composition with controlled release of cannabinoids and opioid agonists, and antagonists for addiction or dependence treatment.

The company added new products to its InfinityLab LC Series which will be showcased at HPLC 2017 in Prague.

SK Biotek plans to operate the Swords, Ireland API manufacturing facility as a contract development and manufacturing site.

Sartorius Stedim Biotech combined the company’s ambr 15 bioreactor system with the Nova BioProfile FLEX2 cell culture analyzer for laboratory experiments.

The three regulatory agencies have agreed to data requirements for development of new antibiotics.

Advances in chemical synthesis are enabling greener, more cost-efficient processes for API manufacturing.

Acasti Pharma and CDMO CordenPharma designed and implemented a continuous process for purifying raw krill oil for production of omega-3 phospholipid.

Cambrex announces expansions of its North Carolina API pilot plant and Kalskoga, Sweden large-scale manufacturing facility.

The author describes the construction approach of a phosgene R&D laboratory and a medium-scale commercial phosgenation plant at Valsynthese.

The agency published an action plan to nurture innovation and drug development by SMEs.

Approval of breakthrough therapies requires expedited quality assessment.

The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.

Efficient synthesis of complex cannabinoids is possible while avoiding marijuana cultivation.

Spectrum Pharmacy Products opens pharmacy institute for training in pharmaceutical compounding.