Manufacturing

A recent FDA guidance places greater attention on cocrystals as a tool in solid-dosage formulation.

The authors describe the background and applications of fully formulated aqueous shellac for film-coating systems.

Case studies on the manufacture of a bluk powder and the development of a tablet show the application of QbD principles.

A new standard from the International Society of Automation addresses information technology security solutions for manufacturing applications.

Cubist issued a voluntary recall of four lots of vials due to the presence of particulate matter.

Conventional cell-imaging systems that provide high quality data can be expensive and complex to use. New systems from Biotek Instruments are designed to overcome these issues.

Installation of a quaternary chiral center with high enantioselectivity using memory of chirality enabled the six-step synthesis of the desired active compound.

Direct tablet compression is simpler than wet or dry granulation, but obtaining the right flow properties to ensure good compaction and uniform drug distribution can be a challenge. Porous silica gel, when used as a glidant, can address these issues.

Extensive adoption of single-use technologies and unidirectional flow reduces cross-contamination risk in the company?s new biomanufacturing facility.

Dr. Reddy's initiates voluntary recall of ranitidine due to microbial contamination.

Parameter Stability Storage adds validated space in anticipation of pending contracts.

Experts, including researchers at I Holland, Natoli, and Rutgers University’s Engineering Research Center for Structured Organic Particulate Systems, are seeking a greater understanding of the fundamental causes of tablet sticking and are developing predictive models to more quickly find solutions to specific sticking problems.

RABS is a flexible barrier system that maximizes product control but minimizes operator interaction when best practices are followed.

Companies exhibit developments for pharmaceutical packaging to meet needs, such as e-pedigree and inspection requirements.

INTERPHEX and the Parenteral Drug Association (PDA) announced a three-year sponsorship agreement, which aligns the objectives of both organizations to service key needs of the global pharmaceutical and biopharmaceutical industry.

Alpha Packaging's new line will consist of more than a dozen injection blow molded and extrusion blow molded bottles.

Synthesis of tetracycline derivatives with novel substituents has been challenging. Using an approach based on a Michael-Dieckmann reaction, new compounds with enhanced antibiotic properties are now being prepared on a large scale.

Adamis Pharmaceuticals agrees to license and potentially acquire 3M's Taper Dry Powder Inhaler technology.

The pharmaceutical majors target biologics and emerging markets in their manufacturing expansion activities and plans.

Stapled peptides offer promise to enable cell permeability, binding to therapeutic targets, and modulation of biological pathways.

Extensive comparability testing is required to ensure that biosimilars have comparable profiles to their reference products.

Advances in techniques and single-use systems are revolutionizing vaccine manufacturing.

View companies' outsourcing profiles from PharmTech's 2013 Outsourcing Resources Fast Locator Index in the following categories.

Successful product development and technology transfer between a CMO and the sponsor company requires a multifaceted collaborative approach. The author, Marga Vines from Grifols International, analyzes a project for an injectable drug for which a new drug application was submitted to FDA.

The investment activity of CDMOs and CMOs reveals the broader business and technical trends of the pharmaceutical industry.