Inter-company Project Teams
Inter-company teams run all partnership projects. These experts agree on the timelines and define the interim objectives required in developing a manufacturing process. Maximum efficiency, safety and cost-effectiveness determine all our project strategies.
Optimal team composition
Designated project managers from each side confer with the team members on a regular basis. A project group will typically consist of senior scientists from process science, fermentation and downstream processing, fill & finish, quality control, quality assurance and supply chain management.
The configuration of people from the two companies is balanced. Communication is the basis for a clear understanding of the scope of work. Specifications and potential changes, as well as timescale and milestones during the development phases are discussed accurately. Both parties are in agreement with exchange of scientists during critical phases of process establishment. Joint meetings at FDA and other regulatory authorities are conducted, to facilitate the implementation of requirements.
Experienced personnel
Everyone assigned to a project team at Boehringer Ingelheim has extensive experience in biopharmaceutical development, manufacturing and quality issues. As a matter of company policy, our people undergo an intensive cGMP education programme. In addition, where new skills and techniques are involved, we provide project-specific training.
