Drug Development

The authors describe a process for generating high affinity, fully human antibodies in culture.

This article focuses on the growing need for effective data management in the life sciences industry-especially among smaller pharmaceutical manufacturers.

The author discusses current expectations in bioprocessing and lays a framework for using NMR to enhance a QbD approach.

Patheon will acquire softgel-specialist company Banner Pharmacaps, based in North Carolina in the US, for $255 million

Consider these tools and strategies for optimizing the manufacturing process.

The authors describe how traditional approaches to analytical method and validation may benefit from alignment with quality-by-design concepts.

Recent research on elucidating the structure and sequence of proteins involves examining the effect of microgravity on protein crystallization and a computational model for protein elucidation.

Potency is a required measurement to determine the amount of active ingredient contained in a preclinical dose formulation. Assessing potency ensures that the test system receives the appropriate amount of active ingredient based on predetermined specifications.

The authors examine the use of various grades of direct-compression mannitol in direct-compression tableting process to evaluate the content uniformity of micronized APIs and excipients in a solid-dosage formulation.

A Q&A with James Ingebrand, Vice President and General Manager of 3M Drug Delivery Systems Division, on recent industry trends.

Particle-engineering technologies, such as crystal design for crystallization and producting cocrystals, particle-size reduction, and amorphous solid dispersions, help to optimize delivery of a drug.

The long-awaited patent cliff that has loomed in the pharmaceutical industry for years has arrived in earnest in 2012, with more than $40 billion in 2011 brand sales facing loss of exclusivity.

This study examines the effect and interaction of variations in hypromellose physicochemical properties.

Fixed-dose combination drug therapies give rise to innovation in solid-dosage formulations and manufacturing.

Researchers have developed injectable, reformable, and spreadable hydrogels capable of delivering sustained release of the proteins they contain for up to six months.

Solubilizers play an important role in dissolving poorly soluble molecules. As the number of poorly soluble lipophilic and/or hydrophobic molecules increases-whether as "brick dusts" or waxy substances-the industry is struggling to identify the appropriate lipophilic excipients (surfactants, solubilizers, solvents or polymers) that can be used to develop such poorly soluble formulations into solid dosages and other forms of pharmaceutical products.

A review of taints and odors in the pharmaceutical and consumer healthcare industries.

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

Ties between the biotechnology industry and university research are crucial.

Industry and academia advance novel approaches for achieving enanioselectivity.

USP optimizes identification tests and impurities procedures.

Development of viable dosage forms for poorly water-soluble compounds continues to be a significant challenge for formulation scientists, and insufficient bioavailability of such compounds may result in development delays or failures.

The authors describe a solid form technology platform used to optimize salt selection, cocrystallization identification and modification, or the development of a free form.

Pfizer has two manufacturing facilities in Germany for high-potency manufacturing, respectively in Freiburg and Illertissen. Pharmaceutical Technology's Executive Editor Patricia Van Arnum visited the facilities and spoke to the company about the design and operation of these facilities.

The authors describe a QbD study that was performed to optimize a coating system.

A Q&A with BASF moderated by Patricia Van Arnum.

Rob Blanchard and Clive Roberts discuss the issues surrounding tablet sticking.

The authors explain chemical transformations that are achievable through certain biocatalytic routes.

An industry roundtable representing Metrics, Cambrex, Carbogen Amcis, Euticals, Ferro Pfanstiehl, and SAFC.

Approaches to scaling up API syntheses center on ways to optimize process conditions and operability.