Boehringer Ingelheim has expanded its biopharmaceutical cell line development services and provides drug substance as fast as 13 months at competitive prices. The novel program is called 'Lean-to-Clinic' and leverages Boehringer Ingelheim's established platforms and processes for the production of monoclonal antibodies using the proprietary BI-HEX® high expression system.
The improved approach combines Boehringer Ingelheim's automated high throughput technologies in process science with a lean drug development approach to offer cost-effective services with shorter timelines. Within the Boehringer Ingelheim "one-stop-shop" service drug substances for toxicological and clinical studies may be delivered after only 13 months and drug products for clinical studies already after 16 months.
"'Lean to Clinic' is another milestone of our winning offers strategy to secure technology leadership, flexibility and customer orientation," commented Simon Sturge, Corporate Senior Vice President Biopharmaceuticals at Boehringer Ingelheim. "'Lean to Clinic' consists of streamlined work packages and significantly speeds up cell line development, phase I process development and preclinical and clinical supplies from mammalian cell cultures."
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates in 50 countries and more than 42,000 employees. Since its foundation in 1885, the family-owned company has been committed for more than 125 years to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.Today, Boehringer Ingelheim is one of the world’s leading companies for contract development and manufacture of biopharmaceuticals. All types of services from mammalian cell line or microbial strain development to final drug production can be delivered within a one-stop-shop concept. Boehringer Ingelheim delivers services for pre-clinical development up to global market supply with a strong commitment to its customers at its global manufacturing facilities for mammalian cell culture and microbial fermentation. Boehringer Ingelheim has brought 19 molecules to market and has many years of experience in multiple molecule classes such as monoclonal antibodies, recombinant proteins, interferons, enzymes, fusion molecules and plasmid DNA. Furthermore, high-titer platform technologies for new antibody mimetic formats such as scaffold proteins and antibody fragments are available for the manufacture of customer products.