cGMP Manufacturing

Late stage process transfer

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.

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.

 

 

 

State-of-the-art cGMP

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:
 

  • Because we are a multi-product facility, we maintain an impeccably clean and hygienic manufacturing area with controlled environmental conditions in order to prevent the cross contamination of drug substances. Biopharmaceutical manufacturing areas have been assigned according to ISO classes, e.g. media, feed and buffer preparation (ISO 8), initial seed train (Inoculum) (ISO 7 with ISO 5 biological safety cabinet), seed train and production bioreactor (ISO 8), initial purification (ISO 8) and final formulation (ISO 7 with ISO 5).
  • All manufacturing process steps are controlled by a validated DCS (Distributed Control System) and LIMS (Laboratory Information Management System). Processes are monitored and evaluated on a routine basis using state-of-the-art statistical analysis and trending software.
  • Clearly worded standard operating procedures (SOP) are drawn up according to Good Documentation Practice. At the majority of Boehringer Ingelheim’s manufacturing plants, manufacturing batch records are electronic. This guarantees not only that the complete history of a batch is accessible easily and in a comprehensive form. It also ensures that the steps defined in the procedures are all executed properly and as expected, so that the quantity and quality of the drug substance are supplied as projected.

 

State of the art cGMP at Boehringer Ingelheim’s manufacturing plants

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.

 

Inspection History

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.

 

Reliability

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 Excellence

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.

 

Staff

Our motivated and professional staff is made up of dedicated teams with different qualifications

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.

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Excellence in biopharma process transfer