- Email: [email protected]
Meeting the challenges in freeze-drying of pharmaceuticals and biologicals
European Journal of Pharmaceutics and Biopharmaceutics 85 (2013) 161
Contents lists available at SciVerse ScienceDirect
European Journal of Pharmaceutics and Biopharmaceutics journal homepage: www.elsevier.com/locate/ejpb
Editorial
Meeting the challenges in freeze-drying of pharmaceuticals and biologicals This special issue of the European Journal of Pharmaceutics and Biopharmaceutics focuses on the current challenges in freezedrying. On the occasion of the ‘‘Freeze-Drying of Pharmaceuticals Biologics’’ meeting held since more than ten years every second summer alternating between Breckenridge, CO and GarmischPartenkirchen, Germany several excellent speakers have been invited to submit their contribution for publication. Freeze-Drying in particular requires a combined understanding of process science, formulation aspects and finally container effects. All these aspects are strongly interconnected, affecting each other which in the past led to the impression that freeze drying was rather an ‘‘art’’. The community of freeze drying experts worked hard in the last decades to provide enough scientific contribution to replace ‘‘art’’ by reason and chance by predictability. This is why a thorough physic-chemical understanding of each step and formulation component is simply a must. Consequently a series of contribution in this issue tackle this challenge. Additionally, new technical developments enable a better process understanding and control. Important aspects include the crystallization and phase separation of excipients, a better control of freezing
processes as well as challenging the drying process by using high shelf-temperatures, above the temperature of micro- or even macrocollapse. A number of formulation case studies from industry and academia are presented including freeze-drying of vaccines, nanoparticles or high concentration protein formulations. Freeze drying is typically considered as the safest, most reliable process when dry storage stable forms of sensitive drugs are needed, but is as well stigmatized as being slow, overly expensive and almost inert to real improvement in respective process engineering and formulation knowledge. The contributions compiled in this issue shall try to correct that picture with state of the art research results. In its completeness the special issue will also serve as an easy start and up to date reference for those who are not experts in the field but need to consider freeze drying for their particular work.
⇑
Wolfgang Friess E-mail address: [email protected]
Gerhard Winter E-mail address: [email protected] Available online 29 June 2013
0939-6411/$ - see front matter Ó 2013 Elsevier B.V. All rights reserved. http://dx.doi.org/10.1016/j.ejpb.2013.06.025
Contents lists available at SciVerse ScienceDirect
European Journal of Pharmaceutics and Biopharmaceutics journal homepage: www.elsevier.com/locate/ejpb
Editorial
Meeting the challenges in freeze-drying of pharmaceuticals and biologicals This special issue of the European Journal of Pharmaceutics and Biopharmaceutics focuses on the current challenges in freezedrying. On the occasion of the ‘‘Freeze-Drying of Pharmaceuticals Biologics’’ meeting held since more than ten years every second summer alternating between Breckenridge, CO and GarmischPartenkirchen, Germany several excellent speakers have been invited to submit their contribution for publication. Freeze-Drying in particular requires a combined understanding of process science, formulation aspects and finally container effects. All these aspects are strongly interconnected, affecting each other which in the past led to the impression that freeze drying was rather an ‘‘art’’. The community of freeze drying experts worked hard in the last decades to provide enough scientific contribution to replace ‘‘art’’ by reason and chance by predictability. This is why a thorough physic-chemical understanding of each step and formulation component is simply a must. Consequently a series of contribution in this issue tackle this challenge. Additionally, new technical developments enable a better process understanding and control. Important aspects include the crystallization and phase separation of excipients, a better control of freezing
processes as well as challenging the drying process by using high shelf-temperatures, above the temperature of micro- or even macrocollapse. A number of formulation case studies from industry and academia are presented including freeze-drying of vaccines, nanoparticles or high concentration protein formulations. Freeze drying is typically considered as the safest, most reliable process when dry storage stable forms of sensitive drugs are needed, but is as well stigmatized as being slow, overly expensive and almost inert to real improvement in respective process engineering and formulation knowledge. The contributions compiled in this issue shall try to correct that picture with state of the art research results. In its completeness the special issue will also serve as an easy start and up to date reference for those who are not experts in the field but need to consider freeze drying for their particular work.
⇑
Wolfgang Friess E-mail address: [email protected]
Gerhard Winter E-mail address: [email protected] Available online 29 June 2013
0939-6411/$ - see front matter Ó 2013 Elsevier B.V. All rights reserved. http://dx.doi.org/10.1016/j.ejpb.2013.06.025