Lonza Launches Novel Plasmid DNA (pDNA) Production Platform for Microbial Derived Biopharmaceuticals

December 20,2011 Basel, Switzerland
  • The new pDNA platform results in reduced development time, higher product yields, improved purity and shorter processing time
  • The process is compatible with a variety of E.coli hosts, providing the flexibility of using either a client’s strain or a Lonza developed strain
  • The microbial-based platform is available for process development projects in either Lonza's Hopkinton, MA (USA) or Visp (CH) development and manufacturing facilities

Basel, Switzerland, 20 December 2011 – Lonza, a world leader in biopharmaceutical development and production, announced today the launch of a new microbial-based platform for the production of high-quality plasmid DNA vaccines & therapeutics. This novel pDNA production platform consists of three harmonized processes: fermentation, primary recovery, and purification. Use of this platform process reduces development time required for custom pDNA products compared to existing systems.

“We are pleased to expand our microbial offering with a complete pDNA service platform for this growing market,” said Edwin Davies, Ph.D, Head of Microbial Research and Development Services. “This innovative development platform offers the versatility of multiple host organisms in conjunction with the flexibility of optional on-site strain development services.”

Lonza's pDNA production platform includes an integrated approach to process development. The platform begins with a unique, fed batch, high cell density fermentation process compatible with multiple E. coli host organisms. This high yielding fermentation process is followed by a novel primary recovery process performed under low shear conditions which reduces process time and improves overall product quality and yield. Finally, a unique, two column purification platform based on the differential power of hydrophobic interaction chromatography has been adopted. The use of only two column steps makes the purification process efficient whereby host and product derived contaminants are eliminated while maintaining high product yields.

A major source of structural instability in pDNA production is mobile DNA elements such as insertion sequences (IS) which can affect product quality and safety. For the production of IS free pDNA, Lonza offers customers the Lonza pDNA Platform with Clean Genome® E. coli. This host strain was bioengineered by Scarab Genomics L.L.C. from E. coli K-12 by deleting over 15% of the K-12 genome including all mobile elements and bacteriophage to allow for increased product stability and host strain reliability. This allows for a better safety profile and increased product activity.


About Lonza
Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Products and services span its customers’ needs from research to final product manufacture. It is the global leader in the production and support of active pharmaceutical ingredients both chemically as well as biotechnologically. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts which play an important role in the development of novel medicines and healthcare products. Lonza is also the world leader in microbial control providing innovative, chemistry-based and related solutions to destroy or to selectively inhibit the growth of harmful microorganisms. Its activities encompass the areas of water treatment, personal care, health and hygiene, industrial preservation, materials protection, and wood treatment. In addition, Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. Furthermore, the company is a leading provider of value chemical and biotech ingredients to the nutrition and agro markets.

Lonza is headquartered in Basel, Switzerland and is listed on the SIX Swiss Exchange and secondary listed on the Singapore Exchange Securities Trading Limited (“SGX-ST”). Lonza is not subject to the SGX-ST’s continuing listing requirements. Lonza is subject to the listing rules of the SIX Swiss Exchange, which do not have specific requirements equivalent to the listing rules of the SGX-ST in respect of interested person transactions, acquisition and realizations, and delisting. In 2010, the company had sales of CHF 2.680 billion. Further information can be found at www.lonza.com.

Further Information

Lonza Group Ltd
Media Relations
Melanie Disa
Tel +1 201 316 9413
Fax +1 201 696 3533
melanie.disa@lonza.com

Lonza Group Ltd
Head of Business Development
Europe and Asia
Shiva Khalafpour
Tel +44 1753 504383
shiva.khalafpour@lonza.com

Lonza Group Ltd
Head of Business Development
North America
Ryan Scanlon
Tel +1 201 316 9383
ryan.scanlon@lonza.com

 

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