Sean Cullen's research while affiliated with Sanofi and other places

Publications (3)

Article
Full-text available
A holistic approach was taken to characterise lyophilisers at both laboratory and commercial scale to design a focused validation strategy for commercialising parenteral drug products. Vial heat transfer coefficients (Kv) and equipment mass transfer boundaries were generated for a Lyostar II and three commercial scale IMA Lyomax lyophilisers. Kv st...
Article
Full-text available
In the past two decades, biopharmaceuticals have been a breakthrough in improving the quality of lives of patients with various cancers, autoimmune, genetic disorders etc. With the growing demand of biopharmaceuticals, the need for reducing manufacturing costs is essential without compromising on the safety, quality, and efficacy of products. Batch...
Article
Near-infrared (NIR) and frequency modulated spectroscopy (FMS) were employed, for non-invasive moisture determination of a lyophilized biologic drug product (DP). Development of NIR and FMS provides a rapid non-invasive means of residual moisture measurement, and would be beneficial compared with traditional time consuming, product destructive meth...

Citations

... While the majority of work has focused on liquid formulation development, lyophilization, a method utilized in the pharmaceutical industry to improve the thermostability of a variety of biological drugs 19,20 , has been shown to promote thermostability of recombinant AAV vectors at ambient temperatures 11,21 . This and other types of drying processes may improve the shelf life of AAV 22 , however, they are not scalable and/or practical for the quantity of vectors needed for current target patient populations 23 . In an effort to improve logistic and economic issues associated with the global distribution of vaccines and other biologic drugs to remote, underdeveloped areas, we established a novel process for stabilizing live viruses in a peelable film that can be shipped and stored at ambient temperature 24 . ...
... Moreover, Near Infrared -Frequency Modulated Spectroscopy (NIR-FMS) is a non-invasive, easy and a quick method for determining headspace oxygen and moisture levels in Freeze-dried vials Ward, 2011a, 2011b;Lin and Hsu, 2002;Victor et al., 2017). Correlation observed between Karl Fisher analysis and NIR spectroscopy can make it easier to predict the RMC post drying (Affleck et al., 2021;Brouckaert et al., 2018;Carfagna et al., 2020). This technique can be employed in-line or at-line to analyze all dried vials or bulk product generated via some of the alternative drying technologies. ...