Boehringer Ingelheim has a proven track record in implementing late stage processes in our multi-product biomanufacturing facilities. From a clinical phase development perspective, processes which are transferred into the large scale GMP facility usually fulfill Phase III, initial market as well as commercial needs.
Boehringer Ingelheim BioXcellence™ acts as a sole or second source manufacturer of various market products from customers all over the world. Process validation of several 2nd and 3rd generation processes has also been successfully performed by Boehringer Ingelheim.
We are well aware of the responsibility that comes with contract manufacturing, i.e. of manufacturing consistently reliable biopharmaceutical products for patients. This is why our biopharma manufacturing plants operate under cGMP and are approved as such. cGMP in Boehringer Ingelheim’s manufacturing plants includes the following aspects:
These procedures help us not only achieve the highest levels of compliance. We are also continually striving to improve our processes, both through regular internal audits and by asking external consultants to give us an outside perspective. Lastly and most importantly, we value our partners’ input through their regular audits and leverage these opportunities for continual quality improvement.
Our multi-product manufacturing facilities in Biberach (Germany), Vienna (Austria) and Fremont (USA) are inspected by the European Medicines Agency (EMA), the Food and Drug Administration (FDA) and Health Canada and hold the commercial license for worldwide supplies. All plants meet the requirements of the World Health Organization and the Pharmaceutical Inspection Convention.
For Boehringer Ingelheim, safeguarding manufacturing reliability is key in order to ensure the stability of processes and make sure we deliver on time and at high quality. By adhering to defined processes which are consistently documented, and thanks to the support of electronic systems, we achieve fast and dependable cycle times which help us sustain our manufacturing reliability.
We take a redundancy approach where expedient, e.g. with two identical drug substance manufacturing buildings at the Biberach site, and comparable manufacturing trains at the Fremont site. Another important aspect is the mode of operation within the manufacturing facilities, with 24/7 operation and flexible working shifts. State-of-the-art infrastructure redundancy is maintained through emergency concepts for IT systems as well as for utilities (e.g. a self-sustaining power supply).
Manufacturing (Operational) excellence is an essential topic for Boehringer Ingelheim. The optimization of late stage and commercial processes and ensuring robust process performance is fostered by specialized staff, systems and procedures. Six sigma (Green Belt, Black Belt) trained staff and continuous process monitoring and trending allows us to identify potential measures for improvement. Verification, e.g. in cell cultures, can be performed at the Manufacturing Science and Technology department in small scale systems, prior to applying it at scale.
Our motivated and professional staff is made up of dedicated teams with a variety of different qualifications (e.g. engineers, scientists, technicians). One thing unites them: Every employee has extensive experience in his or her field, as well as an in-depth understanding of the processes involved in biopharmaceutical manufacturing. This allows us to meet the special demands of this challenging sector in an optimal way and focus on the aspects that matter most to our customers.