Abstract
An overview of types of technology transfer (TT) from development to validation of the lyophilized product is discussed. A detailed consideration of various activities that must be performed for successful TT of lyophilized product is provided. Evaluation of functional equivalency among lyophilizers as a tool in transfer of lyophilization cycles is reviewed and described. Such approach provides the basis to establish functional equivalence among different lyophilizers. Once established, functional equivalence can facilitate successful implementation of scale-up and transfer of lyophilization cycles. Such equivalency procedures are desirable in large manufacturing operations, where multiple lyophilizers are used for processing a common lyophilized product, and reduced validation campaigns based upon a matrix approach can save considerable resources and time.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Global Contract Manufacturing Companies. Pharmaceutical and biotechnology, Pharmalive.com Special reports; 2011.
Food and Drug Administration. Q8 (R1) Pharmaceutical development (‌‌http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128005.pdf‌); 2008.
‌Food and Drug Administration. Q9 Quality risk management (‌‌http://www.fda.gov/downloads/Drugs/.../Guidances/ucm073511.pdf‌); 2006.
Food and Drug Administration. Q10 Pharmaceutical quality systems (‌‌http://www.fda.gov/downloads/Drugs/Guidances/ucm073517.pdf‌); 2009.
‌Food and Drug Administration. Guidance for industry and review staff: target product profile-a strategic development process tool. (‌‌http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080593.pdf‌); 2007.
Food and Drug Administration. Q11 Development and manufacture of drug substances (http://www.fda.gov/downloads/Drugs/Guidances/UCM261078.pdf); 2012.
Williams NA, Polli GP. The lyophilization of pharmaceuticals: a literature review. J Parenter Sci Technol. 1984;38(2):48–59.
Skrabanja ATP, de Meere ALJ, de Ruiter Rien, van der Oetelaar PJM. Lyophilization of biotechnology products. PDA J Pharm Sci Technol. 1994;48:311.
Murgatroyd K. Freeze drying: a review. Eur J Parenter Sci. 2001;6:21.
Willemer H. Measurements of temperatures, ice evaporation rates, and residual moisture contents in freeze drying. Dev Biol Stand. 1992;74:123–34; discussion 135–6.
Tang X, Nail SL, Pikal MJ. Freeze drying process design by manometric temperature measurement: design of a smart freeze dryer. Pharm Res. 2005;22(4):685–700.
Nail SL, Johnson W. Methodology for in-process determination of residual water in freeze-dried products. Dev Biol Stand Biol. 1992;74 (Biol. Prod. Freeze-Drying Formulation):137–51.
Trappler ED. Validation of lyophilization: equipment and process. In: Costantino H, Pikal M, editors, Biotechnology: Pharmaceutical Aspects, (Lyophilization of Biopharmaceuticals). Arlington: AAPS Press. 2004. pp. 43–74
Jameel F, Paranandi M. Critical considerations in the transfer and validation of a lyophilization process. Am Pharm Rev. 2006;9(3):53–5.
Jennings TA. Transferring the lyophilization process from one freeze dryer to another. Am Pharm Rev. 2001;5:34.
Jennings TA, et al. Inspection qualification (IQ) and operational qualification (OQ) for a vacuum freeze dryer, Part I: general discussion. PDA J Pharm Sci Technol. 1996;50:180.
Mungikar A, Ludzinski M, Kamat M. Evaluating functional equivalency as a lyophilization cycle transfer tool. Pharm Technol. 2009;33(9):54–70.
Author information
Authors and Affiliations
Corresponding authors
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2015 Springer Science+Business Media New York
About this chapter
Cite this chapter
Kamat, M., Varshney, D. (2015). Lyophilization Process Technology Transfer Towards Product Launch. In: Varshney, D., Singh, M. (eds) Lyophilized Biologics and Vaccines. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-2383-0_17
Download citation
DOI: https://doi.org/10.1007/978-1-4939-2383-0_17
Published:
Publisher Name: Springer, New York, NY
Print ISBN: 978-1-4939-2382-3
Online ISBN: 978-1-4939-2383-0
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)