Downstream Processing

Shire requests US approval to make Flexbumin at plasma plant

26-Oct-2018 By Flora Southey

Shire has filed a US FDA submission to manufacture plasma-volume replacement therapy, Flexbumin, at its new plant in Stanton Springs, Georgia.

Avid expansion to triple process development capacity, says CEO

25-Oct-2018 By Ben Hargreaves

Avid continues its transition to a fully-fledged CDMO by transforming its process development capabilities with new lab space.

Purolite opens 100,000L agarose plant in Wales

28-Sep-2018 By Flora Southey

Purolite Life Sciences’ new agarose manufacturing plant will supply chromatography resins up to 70% cheaper than GE’s offerings, says executive.

Lonza invests $418m in two biomanufacturing solutions

21-Sep-2018 By Ben Hargreaves

Lonza announced it would invest in two new “Ibex Solutions”, which offer manufacturing capabilities to biotechs developing antibody therapies.

BIOTECH WEEK BOSTON

3M aims to clean up with updated purifier product

12-Sep-2018 By Ben Hargreaves

3M used the platform of Biotech Week Boston to discuss its updated Emphaze AEX Hybrid Purifier product.

BIOTECH WEEK BOSTON

MilliporeSigma claims ‘first-of-its-kind’ resin improves efficiency across the board

11-Sep-2018 By Ben Hargreaves

MilliporeSigma used Biotech Week Boston to discuss the release of its Eshmuno CP-FT resin and how it can improve downstream efficiency.

ABL Bio and I-Mab Biopharma ink bispecific antibody deal

14-Aug-2018 By Maggie Lynch

ABL Bio and I-Mab Biopharma have partnered to develop bispecific antibodies for immunotherapy.

Lonza: Out of spec Kymriah ‘not a Novartis issue…it’s an industry issue’

31-Jul-2018 By Flora Southey

The CDMO is working to resolve manufacturing concerns in the “extremely new” CAR T-cell space, says Lonza CEO.

CAR-T concerns for Novartis as Kymriah identified out of spec

25-Jul-2018 By Flora Southey

Novartis is working with the US FDA to solve a manufacturing issue affecting Kymriah, identified as ‘variability in its commercial specifications’, says CEO.

Novasep launches Merck-tested BioSC Pilot for batch and continuous chromatography

26-Jun-2018 By Flora Southey

Novasep has launched a downstream processing tool that combines batch and continuous chromatography for monoclonal antibodies, recombinant proteins and blood factors.

CMO Rentschler signs Ultragenyx fill/finish deal for US supply

01-Jun-2018 By Staff Reporter

Ultragenyx Pharmaceutical is transferring fill/finish activities for Mepsevvi from Rentschler Biopharma’s facility in Germany, to Rentschler Fill Solutions in Austria.

Fujifilm expands fill/finish services for gene therapies in Texas

29-May-2018 By Flora Southey

Fujifilm Diosynth Biotechnologies has added fill/finish capabilities for late-phase and commercial supply of gene therapies and viral vaccines.

Researchers target rapid changes to downstream continuous manufacturing

29-May-2018 By Nick Taylor

Academic research underpins many of the early success stories in continuous manufacturing. Now, Blair Brettmann and her team are working to write another chapter by applying electrospinning and other techniques to downstream processing.

Swedish biologics site a factor in Q1 margin decline, says AZ

25-May-2018 By Flora Southey

AstraZeneca says the build-up of biologics manufacturing capacity at its yet-to-launch facility in Sweden has contributed to a reduced core gross margin this quarter.