Upstream Processing

New human and plant-based expressions systems can enable faster product development and improve quality at potentially lower costs.

USP evaluates raw materials used in the chemical synthesis of peptides.

The biopharmaceutical industry is developing a new approach to controlling variability in raw materials.

A review of the past year's trends in biopharmaceutical approvals shows an above average approval rate.

Researchers are using current understanding of the lyophilization process to predict performance on many levels during both process development and manufacturing.

CMOs may find opportunities in alternative expression services.

Key considerations for implementing single-use components or platforms when moving from research to process development.

Single-use systems and other technologies drive process efficiencies, but there is room for improvement.

Techniques to enable the design and formulation of stable, protein-based therapeutics.

CMC Biologics and OnoSynergy form an agreement from cell-line development.

BioWa and Lonza have entered into a licensing agreement with MedImmune for cell line technology.

WuXi PharmaTech has completed a cell culture capacity expansion, including two 2000 L disposable bioreactors.

The single-use ReadyToProcess WAVE 25 bioreactor system from GE Healthcare Life Sciences is a cell culture device for designed for working volumes in the 0.3 to 25 L range.

A twin-column periodic countercurrent capture process that combines an efficient sequential, countercurrent loading process with a minimal twin-column hardware configuration is described.

Industry experts discuss the implementation of QbD and PAT tools in biopharmaceutical manufacturing.

An analytical method assesses the effects of media condition on cultured antibodies.

This study on a recombinant human follicle stimulating hormone demonstrates the use of virus filters to reduce the risk of contamination.

Jerold Martin considers the types of tubing available to the industry and how to make an informed selection.

First gene therapy and plant-based expression vector products approved in 2012.

Applications of ZFN technology in biopharmaceutical cell-line engineering.

The authors describe the growth characteristics of human mesenchymal stem cells cultured in a stirred-tank bioreactor.

The authors present approaches used to reduce reconstitution time of a lyophilized high-concentration protein drug product.

Innovative products and a range of indications drive the therapeutic antibody market.

A look at vaccine history, markets, manufacturing, and overcoming the scale-up dilemma.

Tony Hitchcock of Cobra Biologics discusses challenges posed by production of viral vectors for vaccines.

What the industry's future holds and what needs to be done to get there.

Conjugation of a biologic to a carrier molecule can solve problems in solubility and stability, but introduces its own challenges.

GE Healthcare Life Sciences' ReadyToProcess platform aims to streamline bioprocessing.

Scaling up stem-cell cultures requires careful consideration of the bioreactor design.

This month, Jerold Martin of Pall Life Sciences takes a look at protein recovery through direct-flow microporous membrane filters over the past 25 years.