Tech Review

Effectively upscaling bioprocesses

06.03.2012

Success in the biopharmaceutical industry is mainly driven by the ability to innovate, and the continuous development of new products is crucial in that context. Shortening development times is key. The use of comprehensive bioprocessing equipment supports the quick establishment of valid bioprocesses, and facilitates easy and reliable scale-up from lab to production plant. Genmab scientists have demonstrated how powerful methods can accelerate the development of antibody production processes.


Jolanda Gerritsen and her team at Genmab in Utrecht in the Netherlands have used a fourfold DASGIP Parallel Bio­reactor System to shorten the development time of an anti­body production process up to manufacturing level. In their laboratory, they carried out a screening process for a human mono­clonal antibody (mAb) produced by CHO-cells in the 2L scale. Once the production procedure was established in the DASGIP Benchtop Bioreactor System, they successfully scaled-up the process to 100L in a first step (Fig. 1), and finally to the 1000L production scale, retrieving comparable results in regard to protein quantity and quality.
Reliability and scalability are the crucial parameters in accelerating cell culture procedures for antibody production. Strictly parallel operation in cultivation processes facilitates fast process development and saves time during laboratory scale experiments. Using controlled benchtop bio­reactors allows direct comparison of single-process parameters rele­vant in cell line development or optimisation of the anti­body production process itself. Comprehensive data management can further promote effective use of time.
The main objective was to establish a screening procedure for monoclonal anti­body-producing CHO cell lines with reliable scale-up properties at the Genmab research facilities in Utrecht. The Cell Line Development team aimed to achieve the same antibody titers in large-scale production as were achieved in their small-scale screening cultures, which are fully up and running. They successfully scaled up their process 500-fold.
Impact on the industry
The case study discussed above demonstrates that the use of advanced parallel bioreactor systems can accelerate process development in biopharmaceutical science in a smart and comprehensive way. Parallel operations help save time, and lead to reliable results that are easy to scale up. Parallel design of experiments follows DoE principles, giving an extra plus when aiming for short time-to-market. Depending on the characteristics of the protein of interest, a parallel approach using benchtop bio­reactor systems may deliver results that are precisely similar to large scale, allowing operators even to skip a common pilot­scale development cycle.D

Contact
Claudia M. Huether
DASGIP AG
c.Huether@dasgip.de
Patrick Priem, Jolanda Gerritsen
GenMab N.V.
p.priem@genmab.com, gerritsen@genmab.com

Politics / Law

06.03.2012

London – The European Medicines Agency (EMA) calls it “the biggest change to the legal framework since the establishment of the Agency in 1995.” This year, the EU drug regulators are preparing new so-called pharmacovigilance...

Clinical Trial

06.03.2012

Norway’s Algeta ASA (Oslo) has updated its Phase III survival analysis of Alpharadin in patients with castration-resistant prostate cancer and bone metastases. The analysis showed an increase of 3.6 months in median overall...

Clinical Trial

06.03.2012

Genticel S.A. (Toulouse) has completed enrolment in its Phase Ib study of a lyophilised version of the world’s very first therapeutic vaccine ProCervix, which inhibits infection with the cancer-causing Human Papilloma Virus. The...

Clinical Trial

06.03.2012

The share value of French specialist for cardiometabolic diseases Genfit S.A. (Loos/Lille) took a jump after the company announced its candidate drug GFT505 had met all efficacy endpoints in a pilot Phase II study involving 22...

Clinical Trial

06.03.2012

The US Food and Drug Administration (FDA) has granted a Biologics License Application (BLA) to the HER2 dimerisation inhibitor pertuzumab developed by Roche (Basel) for previously untreated HER2­-positive metastatic breast...

Politics / Law

06.03.2012

A For years, the world’s major patent offices – including the EPO, USPTO and JPO – have been collaborating in the Patent Prosecution Highway (PPH) programme. Under the PPH, an applicant whose claims have been allowed in one...

BioFunding

06.03.2012

Berlin/Dublin – Two EU initiatives are seeking to better predict response to cancer treatments. Researchers from the a6m RESPONSIFY Project will develop biomarker-based breast cancer prognosis tests that could be used to predict...

BioFunding

06.03.2012

Bremen/Brussels – European researchers kicked-off the MicroB3 (Bio­diversity, Bioinformatics, Biotechnology) project in February. Thanks to a a9m EU fund, the 32 groups involved will create a unique bioinformatic resource that...

BioFunding

06.03.2012

A Brussels – The European Commission is boosting its investments and policy activities to foster sustainability. “Europe needs to make the transition to a post-petroleum economy,” said Máire Geoghegan-Quinn in Brussels. In...

Politics / Law

06.03.2012

Brussels – In February, I heard of a slightly mad and very worrying trend in decisions handed down by the Court of Justice of the European Union (CJEU) with regard to IP issues handed up from the national level for clarification....

Displaying results 11 to 20 out of 1982

< Previous 11-20 Next >

© 2007-2014 BIOCOM

http://www.european-biotechnology-news.com/nc/news/messages-archive/archive/browse/1/article/effectively-upscaling-bioprocesses.html

Stock list

All quotes

TOP

  • FLAMEL TECHNOLOGIES (F)14.70 USD11.28%
  • SERODUS (N)3.05 NOK7.02%
  • ADDEX (CH)4.54 CHF5.83%

FLOP

  • ANTISOMA (UK)1.32 GBP-14.84%
  • XENETIC BIOSCIENCES (UK)6.00 GBP-14.29%
  • NOVACYT (F)4.48 EUR-10.04%

TOP

  • SANTHERA (CH)70.65 CHF111.2%
  • ADDEX (CH)4.54 CHF108.3%
  • CELLECTIS (F)13.43 EUR98.1%

FLOP

  • THROMBOGENICS (B)8.67 EUR-51.8%
  • MERCK KGAA (D)63.67 EUR-50.5%
  • VERONA PHARMA (UK)1.20 GBP-43.4%

TOP

  • SANTHERA (CH)70.65 CHF3111.4%
  • GW PHARMACEUTICALS (UK)443.50 GBP843.6%
  • IXICO (UK)55.50 GBP314.2%

FLOP

  • CYTOS (CH)0.24 CHF-93.1%
  • EVOCUTIS (UK)0.21 GBP-92.6%
  • THROMBOGENICS (B)8.67 EUR-73.0%

No liability assumed, Date: 10.07.2014

Job Advert

Executive Director of the IMI Joint Undertaking

The Innovative Medicines Initiative Joint Undertaking (IMI JU) is a public-private partnership between the European Commission and the European Federation of Pharmaceutical Industries Associations (EFPIA).
The Executive Director will lead and manage the Joint Undertaking and take overall responsibility for its operations ensuring the achievement of the Joint Undertaking's objectives. more...

Current issue

All issues

Product of the week

Products

Events

All Events