Drug Development

Tracking changes from spinoffs of chemical companies to life-sciences powerhouses.

Readers point to quality by design as having a significant influence on manufacturing and drug development during the past decade.

Companies roll out expansions in manufacturing high-potency APIs and finished products.

Sponsor companies' increasing focus on strategic outsourcing has changed the rules of the game.

Advances in targeted drug delivery and customized release profiles are key goals.

Improvements in expression platforms and enhanced tools for selecting clones are among the advances of the past few decades.

Flow chemistry and microreactors offer alternatives to traditional batch manufacturing.

Uniform dose formulation is key to meeting safety study requirements.

A look back at key nanoformulation advances and what lies ahead for nanoparticle-based drug-delivery systems.

Gold nanoparticles for targeting tumor sites and elastic capsules using nanosized flakes are some recent approaches used to control and target drug delivery.

Industry experts share perspectives on analytical instrumentation, methods, and data analysis.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the June 2012 edition from EMD Millipore and Meissner Filtration Products.

An understanding of the pan-coating process based on first principles can support successful scale up.

Needle-free jet injection systems, gold-coated nanoparticles, and elastic capsules with nanosized flakes advance targeted drug delivery.

Peptides and related technologies to are starting to improve production.

When designing stability protocols, formulation, storage, and dosing conditions must be assessed.

Extensive physicochemical characterization of the innovator product and the proposed biosimilar provides the foundation for demonstrating biosimilarity.

Industry wants more innovation, but can suppliers meet customer needs?

Partnerships between industry and academic medical centers are expanding to meet R&D needs.

A number of factors need to be considered when evaluating preclinical dose-formulation stability. The authors discuss formulation, storage and dosing conditions.

A technical forum featuring Tim Freeman of Freeman Technology and Carl Levoguer of Malvern Instruments.

Targeted polymeric nanoparticles are an important vehicle for controlling and targeting dosing of chemotherapeutic agents.

Industry experts working with extended-release injectables discuss challenges and solutions to formulating and manufacturing these complex products.

The author discusses potential opportunities to improve the patient experience through formulation and delivery device technologies.

Advances in palladium-catalyzed hydrogenation, visible-light photocatalysis, and chemocatalyisis for heterocycles are some recent developments.

Industry, the public sector, and individuals can play an important role in creating solutions.

In this technical forum, experts describe different methods of rapid microbial testing and their applications.

If a product does not have its own antimicrobial properties, then a preservative must be used to ensure microbiological safety.

There are various theories about how to scale up a solid dosage coating operation in a pan coater. This article provides a basic process understanding and scale-up theory based on first principles.

In Part III of a three-part article, the authors examine various degradation routes of APIs, impurities arising from interactions in formulations, metabolite impurities, various analytical methods to measure impuritie, and ways to control impurities.