Manufacturing

Key business considerations when developing biosimilar products virtually.

When a pharmaceutical supply chain is compromised, there can be disastrous consequences, not only for consumers, but also for manufacturers. Without comprehensive security measures, pharmaceuticals are susceptible to counterfeit, diversion, dilution, tampering and deliberate contamination ultimately compromising patient safety.

This article is the second in a two-part series on extractables and leachables.

This article outlines methods, validation standards, and documentation of sterilization of single-use products using gamma irradiation.

This month, we rewind to "Separations Technology Outlook, Part II: Improved Recovery and Greater Purity."

The authors describe a novel means to control ice nucleation using a sterile cryogenic ice fog.

Virtual biotech CEO Anjan Selz focuses on product development, credibility and differentiation.

The author describes automated equipment that uses functionally closed disposables.

Readers react to the economic turmoil of the past year and look longingly forward to 2012.

The EMA released a concept paper for consultation on Nov. 8, 2011, that recommends a revision to Annex 16 of the Guide to Good Manufacturing of Medicinal Products to address more complicated global supply chains and new falsified medicines legislation. Since Annex 16 was introduced in 2001, a number of positive and negative trends have occurred in the pharmaceutical industry. In particular, confusion has arisen over the role of the qualified person (QP), and harmonization of requirements has been lost between member states. The EMA cites several commonly asked questions within the concept paper:

The authors compare the environmental impact of monoclonal antibody production using fixed-in-place processing and single-use systems.

An overview of applications for disposable components and important property considerations.

With careful analysis to mitigate risk, disposable technology and process closure can enable adaptable designs and reduced costs.

New technology is designed to improve production efficiency by taking advantage of the properties of single-use bags.

Single-use manufacturing may seem like a new trend, but it has actually been around for almost 30 years, beginning in the early 1980s when filter manufacturers began to make small process-scale plastic filter capsules to replace "junior" size stainless-filter housing assemblies.

Defects as small as 10 μm can be detected without compromising product cleanliness using helium integrity testing.

In this quarter's column, highlights from the IBC Single-use Applications meeting, the PDA Single-use Workshop, and the BioProcess systems Alliance International Single-Use Summit are presented.

Single-use systems continue to gain traction among biomanufacturers, especially CMOs.

An evaluation of the technologies needed to develop a safe, effective, and economically efficient vaccine. This article is part of a special section on vaccines.

A Q&A with Rick Hancock, president of Althea Technologies. This article contains bonus online material.

A survey provides insight into drug companies' plans for spending on outsourced services. This article contains bonus online material.

The authors provide insight into microRNA biology, and the simplicity of anti-miR oligonucleotide drug delivery.

The International Society for Pharmaceutical Engineering (ISPE) will soon publish an update for its guide to sterile-product manufacturing facilities. The new publication will replace the original guide, ISPE Baseline Guide: Sterile-Product Manufacturing Facilities, and contain practical information about technological advances in sterile manufacturing.

Developing a quality agreement template for single-use systems.

The market landscape for biosimilars is in flux, with limited penetration now, but with the potential for growth for those who can navigate the market. Plus: A SWOT analysis of biosimilars by Anjan Selz.

The author looks at strategies to minimize particle levels in the finished product when using single-use technologies downstream of final capabilities.

The authors re-examine environmental controls in the context of technical advances in manufacturing.

Incorporating regulatory requirements into the product life cycle is crucial.

The authors describe challenges faced in transfer and scale-up of a fermentation process.

Plasmid DNA-encoding proteins offer many advantages, which are now being used in clinical trials.