Ingredients

The fifth in a series of eight case studies from the Product Quality Research Institute focuses on nonsterile facility cleaning requirements.

John Kelly, vice-president of strategy and transitioning sites for Pfizer Global Supply, discusses the company's manufacturing and supply strategy and network.

The authors examine risk management relating to the quality issues of clinical-trial materials and discuss areas that would benefit from additional consideration and harmonization.

The authors describe the concept of the limiting discriminatory the limiting discriminatory threshold (LDT) as an objective means of evaluating the inherent quality requirement of a large-sample content-uniformity test.

The global excipients market shows moderate growth, increased consolidation, and expansion activity in emerging markets and select product areas.

This risk-management case study focuses on assessing empty capsules.

Where are the new excipients, the new solubilisers and sustained release excipients?

The author prepared and analyzed a detailed design of experiments for the manufacture of a simple tablet formulation. The aim was to test whether tablet hardness and weight could be controlled during the compression process by adjusting certain machine parameters.

Internal and external Web-based communities are changing how pharma companies can innovate.

The author offers perspectives on ways in which pharmaceutical companies and other stakeholders in the supply chain can confront the threat of counterfeit products, cargo theft, illegal diversion, and economically motivated adulteration.

Might European officials reverse their position on acceptable production methods?

The third in a series of eight case studies from the Product Quality Research Institute focuses on facility biocontainment and inactivation.

Biocatalysis, chemocatalysis, and other chiral technologies continue to attract the investment dollars of CMOs and fine-chemical companies.

Direct dosing APIs during R&D studies can reduce the overall testing time of a drug candidate by allowing for a greater throughput of compounds through the R&D department.

The increasing cost of crucial manufacturing input factors, such as energy and raw materials, has been a severe threat to several companies.

Elham Blouet from Roquette explains the importance of carbohydrates for injection and the challenges in this niche market.

The authors desribe the three-stage approach to validation that is outlined in the new guidance and discuss questions surrounding implementation.

The increased trend of outsourcing coupled with a relatively strong economy has seen the fine chemicals market grow at a very high level when compared to historical data.

Excipients are the hidden champions of drug development-no API works consistently without the right excipient. Pharmaceutical excipients, however, require stringent quality management. This article discusses how the supplier of pharmaceutical raw materials should take a central role in ensuring excipient quality.

As contract manufacturers and fine-chemical suppliers gather for CPhI/ICSE, effective strategies for technology differentiation are key in an increasingly competitive environment.

A Q&A with Joe Cascone, director of potent pharmaceutical development at Metrics, moderated by Patricia Van Arnum. Discussion of the key considerations made in facility design, equipment selection, and operations to achieve desired levels of containment.

The market for HPAPIs is growing rapidly with the research industry's emphasis on oncology.

Highly potent APIs (HPAPIs) represent a growing area of interest for the pharma industry. Mark Griffiths, CEO of Carbogen Amcis AG, explains why.

We're all familiar with traditional pills and medicines, but how about medicated chewing gum? Marc Ribe of Cafosa Gum explains how APIs can be incorporated into a novel dosage form that can aid patient compliance.

Clarifying GMPs for excipients used as actives.

A Q&A with Brian Johnson, senior director of supply chain security at Pfizer, moderated by Patricia Van Arnum. Part of a special Ingredients issue.

The authors provide an overview of methods for the quantitative determination of genotoxic impurities (GTIs) in active pharmaceutical ingredients.

Recently, there have been many innovations in the latest techniques and technologies in API purification. In particular, the trend to single-use systems has had a significant impact on processes.

A perspective from Pfizer on the lessons from small-molecule manufacturing that can be applied to biomanufacturing.

The author examines sample-preparations methods used in inductively coupled plasma–optimal emission spectroscopy for four test metals.