Plasmid DNA manufacturing technology - development of Boehringer Ingelheim Austria with BIA Separations

Main Category: Genetics
Article Date: 14 Mar 2005 - 9:00 PDT


In order to meet the growing need for pharmaceutical grade pDNA, Boehringer Ingelheim Austria has developed high cell density fermentation technology achieving titers of up to 1g pDNA per Liter, and has specifically designed equipment for automated and gentle lysis of biomass. A key and novel element of the production process is the use of Convection Interaction Media (CIM®) short monolithic columns for the purification of pDNA. The fast separation speed, outstanding capacity and excellent separation power of CIM® columns developed by BIA Separations allows to increase productivity 15-fold compared to traditional supports. "Our customers clearly benefit from this new development as the process is free of antibiotics, animal-derived raw materials, enzymes and organic solvents and employs powerful CIM® separation technology" says Dr. Kurt Konopitzky, Head of the Division Biopharmaceuticals/Operations at Boehringer Ingelheim Austria.

Boehringer Ingelheim Austria and BIA Separations are both committed to leadership of manufacturing technology and innovation of biopharmaceuticals. The process developed is capable of producing pDNA on a large scale and at current Good Manufacturing Practice compliant levels for clinical and commercial application.

After the successful completion of the joint development the two companies are collaborating on a non-exclusive basis where BIA Separations will supply Boehringer Ingelheim Austria with CIM® columns.

About Boehringer Ingelheim Austria

Boehringer Ingelheim Austria GmbH is one of the top pharmaceutical enterprises in Austria and belongs to the international Boehringer Ingelheim Corporation. The Group, headquartered in Ingelheim, Germany, is one of the world's 20 leading pharmaceutical companies. The Boehringer Ingelheim Corporation operates globally with 152 affiliates in 45 countries and more than 34,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

Boehringer Ingelheim has a strong reputation in the production of biopharmaceuticals with two manufacturing sites in Vienna, Austria, and in Biberach, Germany. Boehringer Ingelheim Austria GmbH has high-tech biotechnological facilities at its disposal and conducts extensive research and development. The company has been involved in microbial fermentation and purification of recombinant proteins since 1982. Boehringer Ingelheim Pharma GmbH & Co KG's facility in Biberach is Europe`s largest operational site for the development and production of biopharmaceuticals using mammalian cell culture technology.

About BIA Separations

BIA Separations is the only worldwide manufacturer of Short Monolithic Columns optimized to meet the research and production needs of the biotechnology industry. Their rigid short monolithic polymeric columns are the first monoliths used on an industrial scale for the purification of proteins, DNAs and virus particles. Based on more than 10 years of experience, BIA Separations has developed a wide range of CIM® that address the growing need for timesaving innovations in therapeutic biomolecule purification. Headquartered in the Slovenian capital of Ljubljana, the company consists of research, production, and analytical labs.

Website BIA Separations d.o.o.
http://www.monoliths.com

Contact:

Boehringer Ingelheim Austria GmbH
Dr Monika Henninger
Phone: +43 1 80 105 2141
Fax: +43 1 80 105 2440
monika.henninger@vie.boehringer-ingelheim.com

BIA Separations d.o.o.
Managing Director
Dr Ales Strancar
Phone: +386 1 426 56 49
Fax: +386 1 426 56 50

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