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Genzyme looks to integrate up and downstream for continuous biomanufacturing

Sanofi's Genzyme files patent for upstream/downstream continuous manufacturing technology

Genzyme has filed a patent application for a technology platform that will bridge the gap between upstream and downstream processing in continuous biomanufacturing. 

Related news

News in brief

European authorities have revoked a Regeneron patent covering a genetic modification technique used to generate mouse monoclonal antibody (mAb) production platforms after an appeal by several European firms.

Biotech company MedGenesis Therapeutix has granted Pfizer an exclusive, worldwide option to license its glial cell line-derived neurotrophic factor (GDNF) protein and convection enhanced delivery (CED) technology to be used in research for potential treatments for Parkinson's disease.

Citing “insufficient” labelling for biosimilars “given their unique scientific and regulatory status,” EuropaBio is calling on the EMA (European Medicines Agency) to amend their labelling requirements.

Almost all of the biosimilars currently approved have been developed using a third-party research organisation according to a survey from the Association of Clinical Research Organizations (ACRO).

Merck KGaA has partnered with bispecific antibody firm Sutro Biopharma to develop and produce antibody drug conjugates (ADCs).

Global Industry News

update

Moving EMA to DG Enterprise will increase risk of adverse events says NGO from in-PharmaTechnologist.com

Shifting EMA oversight to DG Enterprise and Industry will put patients at greater risk of adverse events according to NGO Health Action International, which suspects EFPIA “had a hand” in planned European Commission reshuffle.

Evotec looks to recover payments from Andromeda over faked Phase III data from Outsourcing-Pharma.com

Evotec has taken legal action to recover €3.4m ($4.4m) in milestone payments from Andromeda Biotech which was found to have faked data in a Phase III trial.

Scientists discover novel antibiotic in vagina from in-PharmaTechnologist.com

Scientists looking to solve the looming threat of antimicrobial resistance have discovered an antibiotic in the vagina.

Opinion

Public or private: Where Catalent goes, will other CMOs follow? from Outsourcing-Pharma.com

Following the recent IPO from Catalent, has private equity called time on the CDMO industry? Outsourcing-pharma’s Dan Stanton thinks it has for now.

Diluent mix-up not vaccine most probable cause of Syrian deaths says WHO from in-PharmaTechnologist.com

Use of the muscle relaxant atracuriam to resuspend freeze-dried measles vaccines instead of the proper diluent almost certainly caused the death of more than a dozen Syrian infants according to the WHO.

Dispatches from ChemOutsourcing

ICH elemental impurities guideline expected to be finalized at end of September from in-PharmaTechnologist.com

After much discussion and some confusion , the ICH’s (International Conference on Harmonization) Q3D guideline , which will govern elemental impurities in final drug products, is expected to be finalized at the end of this month.

Spotlight

GSK and Immunovaccine: delivery techs promise to deliver Ebola vax

GSK and Immunovaccine: delivery techs promise to deliver Ebola vaccine

A candidate Ebola vaccine that uses Immunovaccine's formulation technology has stopped cynomolgus monkeys from catching the disease in a...

2020 vision: A look at the future of the biosimilars market
Feature

2020 vision: A look at the future of the biosimilars market

BioPharma-Reporter.com takes a look at the players, patent expiries and legal wrangles that will dominate the biosimilars...

Reinspection lands Alexion with 483 for Soliris plant

Reinspection lands Alexion with 483 for Soliris plant

A US FDA reinspection of Alexion’s Rhode Island facility hit with a warning letter last year has...

Janssen acquires Fynomer mAb platform in Covagen buy-out

Janssen acquires Fynomer mAb platform in Covagen buy-out

Johnson & Johnson subsidiary Janssen has acquired monoclonal antibody (mAb) platform FynomAb through its purchase of private...

Vast majority of ADC manufacturing outsourced, report finds

Vast majority of ADC manufacturing outsourced, report finds

Between 70-80% of ADC (antibody drug conjugate) manufacturing is performed by CMOs, according to a new report .