CINCINNATI, OH, USA, HANNOVER, Germany, and KULMBACH, Germany, February 27, 2012 -- Girindus Group and Axolabs GmbH announce the launch of a strategic partnership combining their skills and capabilities in oligonucleotide lead optimization, manufacturing and analytical expertise to offer customers complete service solutions for therapeutic oligonucleotides from early discovery and preclinical development through clinical stages and into commercialization. With this initiative, Axolabs and Girindus provide worldwide customers engaged in the development of therapeutic oligonucleotides with a seamless and efficient transition from early pre-clinical research to the market, managed under the umbrella of a single long-term partnership.
Axolabs offers complete analytical and bioanalytical services as well as small-scale manufacture for a variety of DNA and RNA oligonucleotides. The services also cover all steps from lead identification and optimization as well as non-GLP pharmacology and early safety assessment.
Girindus is a recognized leader in process development, analytical method development and cGMP manufacturing of oligonucleotide therapeutics from pre-IND development through scale-up to kilogram production, process validation and commercial manufacturing in the FDA inspected plant in Cincinnati. The portfolio also spans manufacture of small molecule APIs, peptide conjugates and delivery tools as well as radiolabeling services.
The combined service solutions cover the whole therapeutic development chain and eliminate the need to transition processes between vendors, thereby efficiently reducing timelines, risks, challenges and costs for customers active in drug development and approaching scale-up.
“We are excited to enter into this partnership with Girindus, a leading manufacturer of oligonucleotide therapeutics” says Hans-Peter Vornlocher, Managing Director Research at Axolabs GmbH. “We share a mutual understanding on how to best serve customers’ needs and, by combining our expertise, we can help to significantly accelerate timelines and improve the quality of oligonucleotide-based therapeutics.”
Marc Lemaître, CEO of Girindus America Inc. and Vorstand of Girindus AG says “I am delighted to cement this alliance with Axolabs. I have known the team in Kulmbach for years, right from the early days of Ribopharma, and I am proud that this experienced team selected Girindus as a partner for GMP work and for commercialization of their pre-clinical service through our sales channel. Our combined skills and experience provide everyone developing oligonucleotide therapeutics with a unique platform covering almost all possible technical needs. This is a significant upgrade in CMO/CRO offering and a great opportunity for our customers.”
Girindus is a recognized leader in process development, analytical method development and cGMP manufacture of oligonucleotide therapeutics from gram to kilogram scale. We offer our clients a broad range of synthesis and services from early-stage up to the commercialization of the drug substance and beyond, including small molecule manufacture and radiolabeling. We operate commercial scale oligonucleotide production at our FDA registered and inspected site in Cincinnati, Ohio, USA, which is also home to our laboratories and pilot plant facilities. Girindus AG, the parent company of Girindus America Inc., operates European Sales & Service from Hannover, Germany. FDA Establishment Registration Number: 3003270485.
Axolabs is a custom research organization providing high-end preclinical solutions and consultancy in the field of oligonucleotide therapeutics. Axolabs’ services comprise oligonucleotide synthesis as well as related analytics, bioanalytics and pharmacology. Built on the foundations of the former Roche Center of Excellence for RNA Therapeutics in Kulmbach, Germany, the company has long-term experience in the development of oligonucleotide therapeutics.
Girindus AG, +49 511 857 3535, Girindus America Inc., +1 513 679 3000, firstname.lastname@example.org, www.girindus.com
Axolabs GmbH, +49 9221 827 628 115, email@example.com, www.axolabs.com