Related Experiment Video
Updated: Aug 16, 2025
13:46
A Facile and Eco-friendly Route to Fabricate PolyLactic Acid Scaffolds with Graded Pore Size
Published on: October 17, 2016
8.7K
Part II: Matrix based scaffold lyophilization facilitates processing as a prerequisite for an innovative packaging
Daniel Kullmann1, Carmen Lema Martinez2, Jörg Lümkemann2
1F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070 Basel, Switzerland; Division of Pharmaceutical Technology, Department of Pharmaceutical Sciences, University of Basel, 4056 Basel, Switzerland.
Summary
Dual chamber bags (DCB) offer a viable alternative to traditional vials for storing lyophilized drugs. This novel medication system ensures drug stability and simplifies preparation for healthcare professionals.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Biotechnology
Background:
- Glass vials are standard for drug storage but pose challenges in intravenous (IV) infusion preparation.
- Issues include needle stitch problems, diluent mix-ups, and complex transfer devices.
- A novel container system could improve IV infusion preparation safety and efficiency.
Purpose of the Study:
- To assess a novel dual chamber bag (DCB) system for storing lyophilized drug products.
- To compare the stability of a monoclonal antibody (mAb) in DCBs versus traditional glass vials.
- To evaluate if DCBs can facilitate lyophilized product storage equivalently to vials.
Main Methods:
- Incorporated an intermediate process container into two different DCB designs.
- Studied the stability of a model mAb formulation over 24 weeks.
- Assessed protein stability, residual moisture, and material permeability in DCBs and vials.
Main Results:
- Drug stability in DCBs was found to be highly dependent on the container configuration.
- Lyophilized drug storage in DCBs was demonstrated to be equivalent to storage in glass vials.
- The DCB system allows for co-storage of lyophilized product and diluent within the administration device.
Conclusions:
- Dual chamber bags (DCBs) are a suitable alternative for storing lyophilized medications.
- This novel system maintains drug stability comparable to traditional vials.
- DCBs can simplify drug preparation and potentially reduce errors in clinical settings.
