Drug Development

External manufacturing plays a crucial role in pharmaceutical companies’ supply strategy. The author examines market trends for the captive and merchant global market for active pharmaceutical ingredients and intermediates.

Australian team develops method for making ultrafine particles for more efficient drug delivery.

The report highlights a need for greater third party certification to ensure GMP vigilance.

Novel, atom-efficient routes to amides from esters and carboxylic acids for more sustainable manufacturing.

New routes enable the efficient synthesis of enantiopure sulfinamides and structurally and sterically diverse P-chiral phosphine oxides.

Osmotic systems offer versatility for delivering drugs with varied properties and dosage requirements.

Claudia Roth, President of Vetter Development Service USA, discusses trends in single-use technology for clinical manufacturing.

Falsified Medicines Directive requires imported APIs to have written confirmation of GMP standards.

Contract service providers expand capabilities in API and finished product manufacturing to meet demand for high-potency drugs.

GE Healthcare's partnerships with iBio and Brazil's Bio-Manguinhos/Fiocruz for a new plant-based multipurpose biopharmaceutical and vaccine manufacturing facility move plant-based protein production to the next level.

The US and EU move forward with measures to fortify the pharmaceutical supply chain.

Cocrystals can enable the formulation of solid dosage drugs, but the FDA's final guidelines have left concerns about how their use could impact development timelines, the drug product manufacturing process, and the intellectual property position of products containing cocrystals.

Eisai has launched a new dry syrup formulation of its Alzheimer's disease treatment Aricept (donepezil hydrochloride) in Japan.

Until recently, glycan analysis has been a slow, labor-intensive process more widely used late in bioprocess development. New high-throughput methods are changing that.

Combination product design takes second prize in the National Collegiate Inventors and Innovators Alliance Biomedical Engineering contest.

New production capabilities in Normandy, France will include a cleanroom.

Facility will use mammalian cell-culture technology and be ready for operations by 2016.

Researchers at the Scripps Research Institute advance heteorcylic chemistry trhough new reagents and reaction-tracking techniques.

Kurt Nielsen, PhD, chief technology officer and senior vice-president of R&D at Catalent Pharma Solutions, discusses strategies for solubility and bioavailability enhancement of poorly water-soluble drugs.

Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products made from its facility in Ingelheim am Rhein, Germany.

Dynamic testing and advances in shear testing provide better insight into powder physical properties and external variables that affect powder behavior.

Access to extremely low and consistently controlled reaction temperatures can improve product yields and selectivities while also reducing costs.

New platform technologies and polymer chemistries may facilitate self-administration, longer-term delivery, and targeted delivery of parenteral drugs.

Applications of ZFN technology in biopharmaceutical cell-line engineering.

While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.