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Headlines > Downstream Processing

Biocon's second fill/finish line at Bangalore site to come online later this year

Mylan and Biocon Neulasta biosimilar to go under US FDA scrutiny

17-Feb-2017 - Biocon’s biomanufacturing facilities in India will need a “meaningful capacity expansion” to cope with long-term global biosimilar demand, the firm says.

Sanofi awaits FDA inspection of fill/finish plant before Q1 Kevzara resubmission

09-Feb-2017 - Sanofi intends to resubmit its licensing application for Kevzara within the next few weeks following subject to a US FDA re-inspection of a French fill/finish plant.

German affinity chromatography tech firm changes hands, changes name

08-Feb-2017 - German private equity firm UV-Cap GmbH has bought Scil Proteins and renamed the affinity chromatography tech company Navigo Proteins.

Saudi CDMO’s fill/finish plant to offer Big Biopharma access to local benefits

01-Feb-2017 - Saudi Biotech Manufacturing has selected Swedish engineering firm KeyPlants to design and build a fill/finish plant for biological APIs.

Sandoz awaiting facility inspections before filing Humira biosimilar in US

27-Jan-2017 - Capacity upgrades and US FDA discussions delayed the filing of Sandoz’ Humira biosimilar, the company has confirmed.

Amatsigroup buys French Pyrofree manufacturing specialist Disposable-Lab

23-Jan-2017 - Amatsigroup has acquired single-use processing equipment and packaging tech firm Disposable-Lab SAS as part of a plan to increase its revenue to €50m this year.

Cell preservation prosperity: BioLife and Cryoport up on personalised meds

20-Jan-2017 - With increased interest in cell and gene therapies, BioLife Solutons has reported a 28% year-on-year growth in sales of biopreservation media, while Cryoport has struck another logistics deal.

UPDATED: UCART19

Servier universal CAR-T therapy outsourced to Belgian CDMO

18-Jan-2017 - Servier has recruited CDMO MaSTherCell SA to manufacture its universal CAR-T candidate UCART19, licensed from the biotech Cellectis as an off-the-shelf cell therapy for leukemia.

GEA and Siemens team on continuous processing tech

17-Jan-2017 - Siemens and GEA have developed a continuous manufacturing platform for pharmaceuticals that integrates the former’s quality control software.

Strategic partnership forms single-source solution for biopharma

10-Jan-2017 - CSSi LifeSciences and BioMARC have announced a strategic partnership to provide 'fully cohesive product development and support' for vaccine and biologic development. 

COLD CHAIN

Cryoport to deliver Gradalis autologus immuno-oncology therapies across US

05-Jan-2017 - Cryoport’s network of cold chain logistics will support the delivery of Gradalis Inc’s autologous cell therapy to various cancer trial sites across the US.

Prokarium and Probiomed team to scale-up thermostable oral vaccine

04-Jan-2017 - The project funded by the UK and Mexican governments will look to prove the scalability of Prokarium’s oral vaccine platform, the firm says.

Repligen adds single-use filtration tech through TangenX acquisition

20-Dec-2016 - Repligen has bought Novasep subsidiary TangenX Technology for $39m, adding single-use tangential flow filtration (TFF) cassettes to its downstream offering.

apceth Biopharma joins Lonza as bluebird bio cell therapy contractor

15-Dec-2016 - bluebird bio Inc has hired apceth Biopharma GmbH to make its candidate ALD cell therapy Lenti-D and its thalassemia treatment LentiGlobin for the European market.

BMS reshuffles US operations with multiple R&D closures and construction

14-Dec-2016 - Bristol-Myers Squibb has announced plans to pull the plug on some US facilities and streamline construction and investment around “vibrant academic ecosystems”. 

Growth in biologics and vaccines leading injectables business, Aptar Pharma

12-Dec-2016 - Aptar Pharma is nearing completion of its US-based manufacturing site, as it continues to expand globally to keep pace with growth in the injectable drug delivery industry.

Sanofi and Merck & Co team with Natrix on 'truly disposable' Protein A platform

07-Dec-2016 - Sanofi, Merck & Co. and downstream technology firm Natrix have teamed to develop a chromatography system with a productivity level capable to enable a fully-integrated downstream platform.

GSK extends single-use purification tech R&D deal with Puridify

06-Dec-2016 - The development partnership has been extended as GlaxoSmithKline looks to make clinical trial scale batches using Puridify’s Protein A alternative to packed bed chromatography columns.

Cook and Asymptote to launch water-free automated cell thawing tech

30-Nov-2016 - An automated system co-developed with Cook Regenetec offers a more controlled and repeatable method of thawing cell and gene therapies than traditional techniques, says Asymptote.

Complexity of new logistics policy may stunt China vaccine industry, Sinovac

29-Nov-2016 - Sinovac’s vaccine sales recovered in Q3 after it restarted activities halted while it brought operations into line with new Chinese distribution regulations.

Cold chain challenges evolving with industry, Cryoport

23-Nov-2016 - While the temperature is dropping outside, keeping clinical trial therapeutics and biospecimens at the right temperature during transportation is a challenge year-round.

Lyophilised biologic reconstitution IP up for grabs after XstalBio folds

22-Nov-2016 - A technology developed to reduce time and increase safety when reconstituting lyophilised biologics has been put for up for sale after XstalBio's insolvency.

Novasep eyes Japan's bioprocessing market with chromatography BD contract

18-Nov-2016 - Novasep has expanded a partnership with AR Brown to supply its chromatography equipment to Japanese biomanufacturers.

Repligen: resin recovery feature a ‘differentiator’ in chromatography space

08-Nov-2016 - A resin recovery feature being added to its larger prefilled chromatography columns offers an ‘insurance policy’ for drugmakers, says Repligen.

Shire closing US plant as it begins to assess post-Baxalta manufacturing footprint

04-Nov-2016 - Shire says it is closing a plasma fractionating facility in Los Angeles, US but remains positive it can successfully manage its post-Baxalta manufacturing network of 17 sites.

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