Process Development

The changing regulatory and manufacturing environment is ushering in a new approach to drug development.

The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

Increasing demand for biologics is driving the need for innovation in bioprocessing.

Late-stage and commercial biomanufacturing pose a challenge to cell-culture processing.

The company will provide the first FlexFactory manufacturing platform for cell therapy manufacturing.

Higher cell titers and cell densities have posed a challenge to cell harvesting, a crucial step in biologics manufacturing.

Transcriptomics plays a role in influencing the production of recombinant therapeutics in microbial and mammalian hosts.

Ingenza, in partnership with the University of Dundee and Drochaid Research Services, will work on a project to recycle CO2 emissions from bioprocessing plants to serve as feedstock and energy inputs.

GE Healthcare and the Centre for Commercialization of Regenerative Medicine (CCRM) will support scale-up efforts by DiscGenics for a new cell therapy intended to treat back pain.

Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.

A validation plan developed to support a process unrelated to bio- pharmaceutical manufacture is applied to bio- pharmaceutical processes and systems.

More published data and initial regulatory approvals are needed to drive adoption of continuous bio-manufacturing.

Process understanding and careful assessment of risks are essential in developing viral clearance programs.

This is the first of a series of three articles about validation and technical transfer in the bio- pharmaceutical industry.

Sartorius Stedim Biotech has launched a new automated parallel bioreactor system for perfusion culture.

GlobalData reports the need to shift away from egg-based manufacturing of vaccines in light of influenza-related deaths.

Modeling at various stages of the data analytics continuum aids scale comparison of a bioreactor.

The study suggests that circumventing evolution in cell factories can enable the commercialization of new biobased chemicals to large-scale.

A collaboration between The Centre for Process Innovation and The Roslin Institute aims to develop commercially viable and scalable methods of producing biologics using transgenic animals.

The funding from the Walloon Region will enable Univercells to start developing a manufacturing platform aimed at driving down costs of biosimilars manufacturing.

The company has completed development of a first-generation production process for its chimeric antigen receptor regulatory T cell product portfolio and is selecting a CMO for clinical supply.

Miniature bioreactors add value by reducing validation efforts.

Use of a subspace model is a viable method to characterize process space variables and optimize process performance.

As Europe strives to firmly incorporate quality-by-design principles, there are several key issues that still need to be addressed.

EU authorities are stepping up their efforts to incorporate QbD principles.

Insights on single-use systems implementation and exploitation in biopharmaceutical manufacturing and processing, based on a QbD approach.

The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.

A report commissioned by FDA evaluates the QbD paradigm.

Two case studies show how advanced information technologies make process development more efficient.