Drug Development

The evolving bio/pharmaceutical business model poses risk for CMOs.

The author reviews significant changes to GMP for excipients in the forthcoming American National Standard, including a risk-based approach to excipient manufacture, why new requirements were proposed, and their potential impact to excipient manufacturers.

This article provides guidance for industry on how to comply with the pending American National Standard on excipient GMP, with a focus on risk assessment.

This article considers the different conditions to which the powder is subjected in the tableting process, and discusses which powder properties should be measured to accurately reflect likely powder behavior in the process.

Pharmaceutical companies, equipment providers, contract-service providers, and excipient manufacturers apply various approaches for improving solubility. The article examines some recent developments.

Taste-masking is an important consideration to ensure patient compliance.

Experts in solid dosage discuss the formulation and manufacture of multilayer tablets.

FDA answers key questions about the October 2011 guidance on using physical–chemical identifiers in solid oral dosage products to help prevent and avoid counterfeiting.

Boehringer Ingelheim's Heribert Häusler tells us about parametric release and real-time testing.

With the increasing use of hot-melt extrusion, extruder manufacturers have developed mid-size twin-screw extruders that facilitate process development and scale-up to commercial processes.

The author discusses the relative advantages and disadvantages of lyophilization in vials and dual-chamber systems.

As biopharmaceutical development and commercialization increases, companies are expanding their cold-chain capabilities.

A new class of nanoparticles hold promise for preventing premature drug release and offering greater accuracy and effectiveness in drug delivery.

Debottlenecking downstream mAb purification.

A technical forum featuring Catalent Pharma Solutions, SAFC, and Neuland Laboratories.

Does nanotechnology offer a cure-all or a kill all? We speak with Ruth Duncan about the real potential of nanomedicines.

We bring industry experts together to discuss the importance of self-administration and what injection technologies are best suited to this cause.

The authors designed an upper punch with a removable punch tip to determine a tablet formulation's propensity to stick by weighing the mass of powder adhered to the punch tip.

Challenges remain, particularly for early-stage biopharmaceutical companies.

Some recent advances involve strategies for accelerating reaction discovery, approaches for inducing chirality and stereochemical analysis, and applications in nanotechnology for protein elucidation.

Industry experts discuss formulation and technical challenges in multilayer tablet manufacture.

Nanosized systems are important in drug delivery. Such nanosized systems include liposomes, nanocrystals, micelles, colloidal particles, quantum dots, and dendrimers. Dendrimers are class of synthetic macromolecules with highly branched, monodispersed, circular, and symmetrical architecture that are used as carrier molecules in drug delivery.

Expansion activity was limited as fine-chemical producers and CMOs of API and intermediates grapple with changing industry fundamentals.

As the excipient supply chain becomes more complex, industry must up the ante to comply with new standards and regulations.

New product reviews for December 2011, focusing on manufacturing.

Drug shortages, supply-chain security, generic-drug incursion, and flexible manufacturing models are some of the issues shaping the bio/pharma industry.

Precedents set in the historic Barr case continue to raise questions over suitable sample-size criteria.

A Q&A with Deborah Tanner, executive vice-president and group president of R&D laboratories at Covance, on recent industry trends.

Readers react to the economic turmoil of the past year and look longingly forward to 2012.

Pharma companies must balance demand for new drugs while facing reduced R&D spending.