Drug Development

Using a QbD approach in the development and formulation of topical products will enable the drug developer to provide a robust control strategy for manufacturing.

This article examines IVBE testing requirements for topical creams and explores some of the analytical techniques necessary.

The human skin protects the body from physical, mechanical, and chemical insults while preventing endogenous water loss. This function is predominantly achieved by a thin (10–30 µm) cornified outermost layer-the stratum corneum (SC)-generated through terminal differentiation of the basal epidermal keratinocytes. The stratum corneum protects the human body, but also severely limits drug delivery into and across the skin.

Thixotropic gels, thermosoftened systems, and self-emulsifying systems have expanded the range of potential excipients for liquid-filled hard capsules (LFHC).

API-in-capsule approaches enable pharmaceutical companies to quickly assess new drug candidates with reduced API consumption and to increase speed to clinic.

Protagen Protein Services, a CRO, now offers quicker and more accurate characterization of biomolecular stability using differential scanning calorimetry (DSC).

The new Testa Center in Uppsala, Sweden is a collaborative test bed offering biotechnology equipment from GE Healthcare for process development.

Researchers from the Department of Chemistry and Warwick Medical School developed a way to synthesize polymers to accelerate antimicrobial activity screening.

Pharmaceutical companies are developing new strategies to address the ever-increasing development costs for new drug therapies and maximize the value of their existing drug portfolio.

The agency issued a draft guidance on developing new medication-assisted treatments for opioid-use disorder.

The companies will collaborate on the discovery, development, and commercialization of cell therapies for cancer.

Boehringer Ingelheim joins Oxford BioMedica, UK Cystic Fibrosis Gene Therapy Consortium, and Imperial Innovations to form a partnership for developing a new gene therapy to treat cystic fibrosis.

This article describes the approaches used during the development of a dexlansoprazole delayed-release orally disintegrating tablet (ODT) to evaluate tablet size and texture as they relate to disintegration rate and patient experience; in addition, the resistance to alcohol was also characterized.

Low-temperature chemistry enables performance of more challenging and selective chemistry.

Development costs and time to market continue to put pressure on the biopharma industry, driving the need for innovation in methods and technologies.

GlaxoSmithKline and 23andMe, a personal genomics and biotechnology company, will partner to research and develop new drugs using human genetics.

API can be mixed with silicone and other polymers to create drug-delivery combination products.

The National Science Foundation grant will be used to commercialize a synthetic biology platform for cancer drug development.

Waters’ acquisition of Prosolia’s DESI technology boosts its mass spectrometry imaging portfolio.

FDA and ICH seek comment on new exposure levels for cadmium in drug products.

AbbVie will grant Mylan license to launch a biosimilar to AbbVie’s Humira.

CPhI Korea to feature zone for finished dosage formulation drug products.

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

Sanofi will open a R&D operations hub in Chengdu, Sichuan province, China, with a focus on digitalization and big data analysis.

After 30 years of biologic-drug advances, the industry and patients still have a lot to learn.