Manufacturing

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.

The authors give special consideration factors affecting blow–fill–seal technology.

Single-use conference roundup.

The authors present a case study identifying a contaminant.

Clear documentation and open communication are essential for effective technology transfer.

An off-the-shelf, single-use perfusion system.

Addressing supply-chain challenges.

Nigeria Looks to Simple Packaging Controls and International Cooperation to Curb Counterfeit Drugs

Supply-chain analytics can lead to increased profitability.

The authors present lessons learned from a case study of the transfer of a cell culture biotherapeutic process to a CMO.

The authors discuss the use of single-use bioreactors.

Comparing the economic feasibility of a typical glycosylated protein.

Although some aspects of single-use components can be standardized, it is unlikely that any materials or design features will become a commodity

The role of TLR agonists has expanded, and now the molecules can be found in a variety of non-vaccine therapeutics.

The global head of technical operations at Novartis talks about new technologies for vaccine development and manufacturing.

Safety concerns remain for developing replicating vectors based on the pathogen human immunodeficiency virus type 1.

Virosomes present novel drug-delivery vehicles with distinct advantages over liposomes.

A case study to compare the performances of several types of mixing in disposable bags with stainless steel bioreactors.

Apply a DoE strategy to test several formulations in parallel.

Sanofi Pasteur's disposables implementation plan is part of a larger evaluation of technology innovation. Here's how they approach it.