Manufacturing

The updated edition of William Whyte's book provides information for novices and seasoned professionals alike.

Serialized product codes serve as the foundation of ePedigree records and product traceability.

Fallout escalates from McNeil recall and Genzyme shortages as regulators review oversight.

Industry's focus on cost cutting has led to a dangerous gap in training and knowledge.

The authors discuss the statistical tools used in experimental planning and stategy and how to evaluate the resulting design space and its graphical representation.

Cases of overlooking proper packaging, reconstitution, directions, and dissolution.

Manufacturers and regulators on both sides of the ocean move to ensure the safety of heparin and other globally distributed drug products.

Industry can meet its responsibility to society by considering innovative pricing and partnerships.

Pharmaceutical Technology's annual analysis of the pharmaceutical majors' activities shows a shrinking global manufacturing network amidst company restructuring, product intensification in biologics, and a strategic focus and push to emerging markets.

Relationship management is a limiting factor to growth in biomanufacturing outsourcing.

Editors' picks of pharmaceutical science and technology innovations.

As emerging markets become increasingly important for the pharmaceutical majors, companies are re-evaluating their outsourcing strategies. This article is part of the 2010 Outsourcing Resources special issue.

The different pathways to regulatory approval of a biosimilar vary worldwide, ranging from no pathways at all in some developing countries, to the complex and precise mechanism that exists in Europe.

Many pharmaceutical companies in the UK have adopted a direct-to-pharmacy distribution model, which enables companies to more tightly control their supply chains.

The health of the contract-services industry is improving but the market is signaling tougher competition ahead. This article is part of the 2010 Outsourcing Resources special issue.

Overall Equipment Effectiveness has been shown to identify the root cause of inefficiencies.

Representatives of SOCMA and IPEC explain new quality agreement templates and their use for meeting regulatory expectations and securing the pharmaceutical supply chain.

A new guideline for conducting bioequivalence studies was adopted by the CPMP in January and it becomes fully effective as of August 2010.

The authors describe recent market trends and indicate the likely future direction of the pharmaceutical and biopharmaceutical industries. This article is part of the 2010 Outsourcing Resources special issue.

We speak to The European generic Medicines Association about the environment for biosimilars.

The recent amendment to Annex 1 has seen controversial changes relating to the capping of vials.

New isolator and disposable technologies are set to assume a greater role in pharma manufacturing, according to a recent conference in Germany.

The EMA's Guideline on Similar Biological Medical Products provides overarching guidance, but since its introduction a range of more specific guidelines have also been developed.

As biopharmaceuticals will soon make up 50% of new drug approvals there has been a significant rise in interest in the field of biosimilars.

The biggest differences between the development of a biosimilar and a generic medicine lie primarily in the preclinical and clinical stages.

The author describes the importance of risk management and offers strategies for risk-management preparedness in supply chains.

Why the primary defence against biosimilars is to develop better molecules that can be launched quickly.

With more hands in the manufacturing pot, a good contingency plan is crucial to success.

What are the newest trends in pneumatic conveying of pharmaceutical powders and blends?

Leading CMOs share their experiences with regard to client expectations and performance indicators as well as strategies for adapting to the changing contract-manufacturing environment. This article is part of the 2010 Outsourcing Resources special issue.