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Glycosylation technologies for biosimilars and ‘biobetters’ Biosimilars/Research | Posted 10/03/2010

According to Mr Hans Baumeister and Mr Steffen Goletz of Glycotope, human cell lines providing a human glycosylation pattern – such as those of Crucell (PER.C6), Cevec (CAP) and Glycotope (GlycoExp...

Biosimilar epoetin zeta gets positive EMA-CHMP opinion for SC route in renal patients in EU Biosimilars/News | Posted 10/03/2010

Hospira announced on 22 February 2010 that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended for approval the administration of Retacrit (epoetin zeta) subcutaneously...

Rituximab gets US FDA approval for chronic lymphocytic leukaemia Biosimilars/News | Posted 10/03/2010

The US FDA has approved Roche’s Genentech/Biogen Idec's anti-CD20 monoclonal antibody Rituxan/MabThera (rituximab) plus chemotherapy for people with either previously untreated or previously treate...

How to tackle overcapacity in monoclonal antibody production Biosimilars/News | Posted 09/03/2010

In the early days, most monoclonal antibody (MAb) therapies required high dosages, as pointed out by Ms Gail Dutton in a Genetic Engineering & Biotechnology News Feature Article on 15 February...

Monoclonal antibodies modelling - predictive analytics Biosimilars/News | Posted 09/03/2010

Improved analytics is helping to ensure that the active pharmaceutical ingredient (API) quality attributes of monoclonal antibodies (MAbs) are identified as early as possible, determining both the...

Improving monoclonal antibody production - antibody-drug conjugate technology Biosimilars/News | Posted 09/03/2010

Researchers are developing new approaches to improve monoclonal antibody (MAb) production, as pointed out by Ms Gail Dutton in a Genetic Engineering & Biotechnology News Feature Article on 15 F...

Modern monoclonal antibody production - focus on quality by design, timelines, cost Biosimilars/News | Posted 09/03/2010

In the decade since severe capacity constraints limited monoclonal antibody (MAb) production, the industry has adjusted, so that today, overcapacity is the issue, along with developing techniques t...

Will the EU biosimilars pathway be applicable to monoclonal antibodies? Biosimilars/Research | Posted 08/03/2010

To what extent is the existing framework for biosimilars in Europe likely to be applicable to monoclonal antibodies (mAbs)? This question was verified in a paper by Dr Christian Schneider –member o...