Boehringer says it is rolling out ‘fully disposable’ biomanufacturing
pharmafile | September 18, 2012 | News story | Manufacturing and Production |Â Â Boehringer, CMO, GMP, SUSsÂ
Boehringer Ingelheim says it has developed a production platform for biopharmaceuticals that makes full use disposable technologies both upstream and downstream.
The German drugmaker and contract manufacturing organisation (CMO) said the set-up uses both 100-litre and 500-litre disposable bioreactors for Good Manufacturing Practice (GMP) production of clinical material, as well as smaller-scale equipment for non-GMP projects.
Disposable or single-use systems (SUSs) have been widely deployed across the pharmaceutical industry over the last 10 to 15 years, but have tended to be piecemeal arrangements despite proven benefits in terms of reducing cross-contamination and bioburden risk and overall cost-effectiveness, due to lower capital and operating costs.
Boehringer has now taken this to the next level with a facility that spans both upstream production units such as bioreactors and downstream processing units such as sampling, filtration and purification systems, as well as all the connecting components.
“We have gathered years of experiences from different single use systems in our expert groups and could therefore form a truly unique single use platform for upstream- and downstream processes”, said Hitto Kaufmann, the company’s vice president for process science in Germany.
One of the brakes on adoption of SUSs has been a failure by disposables suppliers to agree on universal standards so that equipment from different vendors can be made interchangeable, but Boehringer says its setup “enables different commercially available single use systems to be operated in the same facility and by the same experts”.
Boehringer has set up a fully integrated system that will be established globally in its mammalian cell production facilities.
The new platform “will significantly ease seamless process transfers, smooth outsourcing concepts and further boosts our … Lean-to-Clinic programme from gene to drug product in 16 months “.
Boehringer recently rebranded its 35-year-old contract manufacturing operations under the new BioXcellence brand. It also announced a €17 million investment round at its biopharmaceutical development and manufacturing capabilities in Biberach, Germany and Vienna, Austria, aimed at boosting GMP production capacity.
Boehringer accounts for 23% of sales revenues and 23% of manufacturing capacity in the global biopharmaceuticals contract manufacturing market, according to market research consultancy Frost & Sullivan.
Phil Taylor
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