Upstream Processing

The Cell Therapy Catapult, a UK non-profit center for advancing cell and gene therapies, will manage the manufacturing center, which will be used for late-phase clinical trials and commercial supply.

Under an NIH contract, Paragon Bioservices will design a manufacturing process for recombinant human rhE-selectin protein.

Representatives from industry supplier companies address innovations, reliability, barriers to adoption, and the role of singIe-use bioreactors in bioprocessing.

Challenges remain for virus removal and validation.

Eppendorf's Cell Culture Consumables have an ISO class/GMP class C clean room production standard.

Fed-batch processes were scaled up from traditional bench-scale bioreactors to large-scale single-use systems.

Careful selection of downstream processing conditions is a must.

Different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture are evaluated.

New approaches to vaccine production are targeting rapid supply for pandemic situations and broadly effective therapeutic treatments.

Gallus BioPharmaceuticals enters a cell line optimization and manufacturing agreement with Omni Bio Pharmaceutical.

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.