Downstream Processing

The authors of this study demonstrate an innovative method that is useful and complements traditional HA assays.

The new program, Cornerstone, integrates process development expertise and novel technology to remove development bottlenecks in the manufacture of gene therapy medicinal products.

The editors welcome technical article contributions from biopharma industry experts.

Successful process intensification with inline dilution requires effective monitoring and control.

Higher cell densities are driving innovations in harvesting, including closed systems for intensified processes.

Real-time monitoring of product- and process-related impurities remains a challenge.

Although downstream efficiency still lags behind upstream, engineering-driven innovation is breaking through boundaries.

Single-use systems offer a solution to the challenges inherent in buffer preparation, which can be the cause of bottlenecking in bioprocessing.

The learning curve for process analytical technology has slowed widespread adoption.

Quality by design brings both challenges and benefits to the development of downstream processes.

Single-use technology is gaining ground in downstream bioprocessing, but challenges stall further adoption.

The company’s Quantum peristaltic pump uses a patented single-use cartridge technology and is applicable to downstream bioprocessing.

The BioContinuum Buffer Delivery Platform offers streamlined buffer management and delivers “contiGuous” bioprocessing.

Pharmaceutical Technology and BioPharm International will present a Keynote Session on Meeting Bioprocessing Manufacturing Capacity Demands on Wednesday, April 3, 2019, during INTERPHEX 2019 at the Javits Center in New York City.

3D printing offers a new design freedom for bio/pharmaceutical manufacturing: whether for “printing” a solid-dosage drug or for creating a piece of equipment for bio/pharmaceutical laboratories or manufacturing facilities.

The latest advances in downstream processing include remote monitoring, membrane chromatography technology, single-use sensors, and new uses of data analytics.

MilliporeSigma added a new cloud-based, remote lab water service and monitoring capability to its Milli-Q CLX 7000 clinical water purification system.

Sartorius Stedim Biotech (SSB) and Novasep will partner to develop systems for membrane chromatography using Novasep’s BioSC platform and SSB’s single-use technology.

Downstream process equipment for mAbs manufacturing must be designed to fit technology developments in upstream processes.

The $21.4-billion acquisition will create stand-alone business within Danaher’s life-sciences portfolio.

New ligands are being developed to meet the separation and purification needs of next-gen biologics.

A key technology that can help achieve a continuous production flow is single-pass tangential flow filtration.

The investment builds on a collaboration the companies entered into in 2007 for various biomanufacturing projects.

GE’s new facility, which will be operational in 2019, will produce a fiber-based chromatography platform for more efficient biopharmaceutical purification.

Fujifilm Diosynth Biotechnologies and the Centre for Process Innovation (CPI) are collaborating to complete the technology transfer of the expression and purification of model monoclonal antibodies (mAbs) as part of AMECRYS, a research project funded by the European Commission.

Survey results and record attendance may show positive signs for established and emerging biopharma regions.

The second half of this article describes the testing methods used by the authors to demonstrate the applicability of single-use mixing technology for virus inactivation.

The companies partnered to build a 500-L single-use pilot-scale plant for biologics production.

The maturation of single-use technologies presents commercial bioprocessing options for small-volume drug products.

This article explores the use of single-use mixing technology in a detergent-based virus inactivation step during a monoclonal antibody production process.