title: An Approach to the Commercial Production of Highly Active Pharmaceutical Ingredients.
abstract: To meet the requirements for production of highly active pharmaceutical ingredients (API) new approaches and technical solutions are required. Prior to the design and construction of a new multipurpose manufacturing facility, a process study was performed to clarify the future needs. During the planning phase, concepts were defined and elaborated to meet production, cleaning, health and safety standards. The ideas were taken into account and a small-scale manufacturing facility was designed and realized accordingly.
authors.affiliation: F. Hoffmann-La Roche AG Grenzacherstrasse 124 CH-4058 Basel, Switzeerland. andreas.beyeler@roche.com.
authors.forename: Andreas
authors.initials: A
authors.lastname: Beyeler
authors.affiliation: F. Hoffmann-La Roche AG Grenzacherstrasse 124 CH-4058 Basel, Switzeerland.
authors.forename: Roland
authors.initials: R
authors.lastname: Wilhelm
authors.affiliation: F. Hoffmann-La Roche AG Grenzacherstrasse 124 CH-4058 Basel, Switzeerland.
authors.forename: Bernd
authors.initials: B
authors.lastname: Brodbeck