Manufacturing

Developing analytical methods and performing related testing is crucial for ensuring the quality of a pharmaceutical product.

Critical process parameters (CPPs) and their associated process controls are crucial to drug development and process validation and to the evaluation of every manufacturing unit operation.

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

On Oct. 22, 2012, a consortium in France announced the establishment of Europe's first ever industrial manufacturing facility dedicated to the large-scale production of novel, advanced cell-based therapy medicinal products.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the October 2012 edition from UFP Technologies and Mettler Toledo.

Strategic management of intelligent devices is important in any processing field, and a new standards committee at the International Society of Automation aims to provide direction so that manufacturers can better utilize the devices' capabilities.

Consider these tools and strategies for optimizing the manufacturing process.

Takeda's US subsidiary, Takeda America Holdings, has agreed to acquire the vaccine specialist company LigoCyte Pharmaceuticals for an upfront payment of $60 million in a move intended to bolster and expand the company's vaccine business.

PharmTech spoke with industry experts about the challenges of implementing disposable chromatography systems.

IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development.

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.

Foreign firms struggle against stricter patent laws, but all is not lost.

Real-time experimentation may offer continuous process improvement.

Today's pharmaceutical companies are striving to reduce costs and maximize efficiencies, and must make decisions on the best way to deploy their limited resources.

Only the strong survive when it comes to pharmaceutical packaging and shipping.

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.

Fluid-Bag Ltd provides comprehensive 900 and 1000 litre flexible IBC systems for liquid and semi-solid products, including filling and discharging equipment. The GMP compliant container system is designed to guarantee uniform liquid, maximise payload and minimise discharge residue (0.5% residue).

Working together affords many unseen opportunities for pharmaceutical innovation.

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

Measuring the size of the market for contract manufacturing services requires a careful hand.

Q&A with David Elder and Richard Wright of Strategic Compliance Consulting, PAREXEL International. Both Elder and Wright formerly served with FDA.

The physical form of an API is an important consideration in formulation development. Particle-engineering technologies, such as crystal design for controlling crystallisation and producing cocrystals, particle-size reduction and amorphous solid dispersions, help to optimise delivery of a drug.