Recipharm gains aseptic clinical trial filling in Sweden
Earlier this year, the new sterile facility at Recipharm’s Formulation Development Centre in Stockholm was successfully audited by the Swedish MPA.
The certificate arrived one month later certifying the facility for the manufacture of sterile/aseptic products for clinical trials to markets worldwide! Whilst this is a new service from the Formulation Development Centre, it is not new to the staff that operates the unit. Between them, they have many years of experience operating sterile facilities for some of the major pharmaceutical companies.
Sture Nordberg, VP Science & Technology commented “Development and clinical trials work is more often than not about speed and efficiency. It is therefore important to be located close to customers. Our geographical position in the centre of the Stockholm-Uppsala region is a great advantage, which many of our customers have already pointed out. The facility also very much complements the clinical trial filling facilities that Recipharm already operates in Basle, Switzerland. Again, this is a significant region for development work in Europe and the companies in that area value the locality”.
The facilities in Stockholm includes the following equipment:
ROTA vial washing machine, ROTA filling machine with a single filling needle and accurate dosing with piston pump, Getinge autoclaves and a Lytzen dry heat steriliser. We mechanically fill bottles in the sizes of 10, 20, 50 and 100 ml. Our maximum batch size is 1,000-2,000 vials, depending on the vial size.
We are also able to handle other vials sizes or bespoke customer devices such as syringes in a Holten LAF.
This new fill-finish capability in the Nordic region together with the Recipharm Biologics site makes it possible for customers to access the primary development of protein formulations right through to the filling in a single organisation. Formulations requiring lyophilisation can be handled by Recipharm in Basle.
The Development Centre is of course still able to offer analytical development, formulation development and clinical supplies of dry and semi-solid formulations as usual.
If you have any specific questions or would like further information, please contact Fredrik Strandberg on +46 8 6024 474. or Fredrik.firstname.lastname@example.org