(2017) Lyophilized product cake appearance:
what
is
acceptable?
J
Pharm
Sci
106:1706–1721
19. Patapoff TW, Overcashier D, Hsu C, Nguyen
TH, Borchardt RT (1996) Effects of reducing
sugars on the chemical stability of human
relaxin in the lyophilized state. J Pharm Sci
85:873–877
20. Pikal MJ (1999) Mechanisms of protein stabilization during freeze-drying and storage: the
relative importance of thermo stabilization and
glassy state relaxation dynamics. In: Rey L, May
JC (eds) Freeze-drying/lyophilization of pharmaceutical and biological products. Marcel
Dekker, New York, pp 161–198
21. Morgan CA, Herman N, White PA, Vesey G
(2006) Preservation of microrganisms by drying; a review. J Microbiol Methods
66:183–193
22. Rey LR (1999) Glimpses into the realm of
freeze-drying: classic issues and new ventures.
In: Rey L, May JC (eds) Freeze-drying/
lyophilization of pharmaceutical and biological
products. Marcel Dekker, New York, pp 1–30
23. Padilla AM, Pikal MJ (2010) Phase separation
of freeze-dried amorphous solids: the occurrence and detection of multiple amorphous
phases in pharmaceutical systems. In: Rey L,
May JC (eds) Freeze drying/lyophilization of
pharmaceuticals and biological products, 3rd
edn. Informa Healthcare, New York, pp
82–111
24. Mockus LN, Paul TW, Pease NA, Harper NJ,
Basu PK, Oslos EA, Sacha GA, Kuu WY, Hardwick LM, Karty JJ, Pikal MJ, Hee E, Khan MA,
Nail SL (2011) Quality by design in formulation and process development for a freezedried, small molecule parenteral product: a
case study. Pharm Dev Technol 16:549–576
25. Patel SM, Pikal MJ (2011) Emerging freezedrying process development and scale-up
issues. AAPS Pharm Sci Tech 12:372–378
26. Ward K, Cowen A, Peacock T (2012) Freeze
drying method. Patent WO/2012/098358
27. MacKenzie AP (1964) Apparatus for microscopic observations during freeze drying. Biodynamica 9:213–222
28. Ward K, Matejtschuk P (2010) The use of
microscopy, thermal analysis and impedance
measurements to establish critical formulation
parameters for freeze-drying cycle development. In: Rey L, May JC (eds) Freeze drying/lyophilization of pharmaceuticals and
biological products, 3rd edn. Informa Healthcare, New York, pp 112–135
29. Franks F, Auffret A (2007) Freeze-drying of
pharmaceuticals and biopharmaceuticals: principles and practice. RSC Press, Cambridge UK
30. Kett V, McMahon D, Ward K (2004) Freezedrying of protein pharmaceuticals - the application of thermal analysis. Cryo Letters
25:389–404
31. Mehta M, Bhardwaj SP, Suryanarayanan R
(2013) Controlling the physical form of mannitol in freeze dried systems. Eur J Pharm Biopharm 85:207–213
32. Duddu SP, Dal Monte PR (1997) Effect of
glass transition temperature on the stability of
lyophilized formulations containing a chimeric
therapeutic monoclonal antibody. Pharm Res
14:591–595
33. Wang W (2000) Lyophilization and development of solid protein pharmaceuticals. Int J
Pharm 203:1–60
34. Grant Y, Matejtschuk P, Dalby PA (2009)
Rapid optimization of protein freeze drying
formulations using ultra scale down and factorial design of experiment in microplates. Biotechnol Bioeng 104:957–964
35. Bourles E, de Lannoy F, Scutella B, Fonseca F,
Trelea IC, Passot S (2019) Scale-up of freeze
drying cycles, the use of process analytical technology (PAT), and statistical analysis. In: Ward
KR, Matejtschuk P (eds) Lyophilization of
pharmaceuticals and biologicals: new technologies and approaches. Humana Press, Springer,
New York, pp 215–240
36. Cherry C (2019) Containment options for the
freeze-drying of biological entities and potent
materials. In: Ward KR, Matejtschuk P (eds)
Lyophilization of pharmaceuticals and biologicals: new technologies and approaches.
Humana Press, Springer, New York, pp
143–155
37. Schneid S, Gieseler H (2008) Evaluation of a
new wireless temperature remote interrogation
system (TEMPRIS) to measure product temperature during freeze drying. AAPS Pharm Sci
Tech 9:729–739
38. Tang C, Nail SL, Pikal MJ (2005) Freezedrying process design by manometric temperature measurement: design of a smart freezedryer. Pharm Res 22:685–700
39. Kessler WJ, Gong E (2019) Tunable diode
laser absorption spectroscopy in lyophilization.
In: Ward KR, Matejtschuk P (eds) Lyophilization of pharmaceuticals and biologicals: new
technologies and approaches. Humana Press,
Springer, New York, pp 113–141
40. Sylvester B, Porfire A, Van Bockstal P-J,
Porav S, Achim M, De Beer T, Tomut ¸a ˘ J
(2018) Formulation of long-circulating liposomes and in-line monitoring of the freezedrying process using a NIR spectroscopy tool.
J Pharm Sci 107:139–148
126
Kevin R. Ward and Paul Matejtschuk
what
is
acceptable?
J
Pharm
Sci
106:1706–1721
19. Patapoff TW, Overcashier D, Hsu C, Nguyen
TH, Borchardt RT (1996) Effects of reducing
sugars on the chemical stability of human
relaxin in the lyophilized state. J Pharm Sci
85:873–877
20. Pikal MJ (1999) Mechanisms of protein stabilization during freeze-drying and storage: the
relative importance of thermo stabilization and
glassy state relaxation dynamics. In: Rey L, May
JC (eds) Freeze-drying/lyophilization of pharmaceutical and biological products. Marcel
Dekker, New York, pp 161–198
21. Morgan CA, Herman N, White PA, Vesey G
(2006) Preservation of microrganisms by drying; a review. J Microbiol Methods
66:183–193
22. Rey LR (1999) Glimpses into the realm of
freeze-drying: classic issues and new ventures.
In: Rey L, May JC (eds) Freeze-drying/
lyophilization of pharmaceutical and biological
products. Marcel Dekker, New York, pp 1–30
23. Padilla AM, Pikal MJ (2010) Phase separation
of freeze-dried amorphous solids: the occurrence and detection of multiple amorphous
phases in pharmaceutical systems. In: Rey L,
May JC (eds) Freeze drying/lyophilization of
pharmaceuticals and biological products, 3rd
edn. Informa Healthcare, New York, pp
82–111
24. Mockus LN, Paul TW, Pease NA, Harper NJ,
Basu PK, Oslos EA, Sacha GA, Kuu WY, Hardwick LM, Karty JJ, Pikal MJ, Hee E, Khan MA,
Nail SL (2011) Quality by design in formulation and process development for a freezedried, small molecule parenteral product: a
case study. Pharm Dev Technol 16:549–576
25. Patel SM, Pikal MJ (2011) Emerging freezedrying process development and scale-up
issues. AAPS Pharm Sci Tech 12:372–378
26. Ward K, Cowen A, Peacock T (2012) Freeze
drying method. Patent WO/2012/098358
27. MacKenzie AP (1964) Apparatus for microscopic observations during freeze drying. Biodynamica 9:213–222
28. Ward K, Matejtschuk P (2010) The use of
microscopy, thermal analysis and impedance
measurements to establish critical formulation
parameters for freeze-drying cycle development. In: Rey L, May JC (eds) Freeze drying/lyophilization of pharmaceuticals and
biological products, 3rd edn. Informa Healthcare, New York, pp 112–135
29. Franks F, Auffret A (2007) Freeze-drying of
pharmaceuticals and biopharmaceuticals: principles and practice. RSC Press, Cambridge UK
30. Kett V, McMahon D, Ward K (2004) Freezedrying of protein pharmaceuticals - the application of thermal analysis. Cryo Letters
25:389–404
31. Mehta M, Bhardwaj SP, Suryanarayanan R
(2013) Controlling the physical form of mannitol in freeze dried systems. Eur J Pharm Biopharm 85:207–213
32. Duddu SP, Dal Monte PR (1997) Effect of
glass transition temperature on the stability of
lyophilized formulations containing a chimeric
therapeutic monoclonal antibody. Pharm Res
14:591–595
33. Wang W (2000) Lyophilization and development of solid protein pharmaceuticals. Int J
Pharm 203:1–60
34. Grant Y, Matejtschuk P, Dalby PA (2009)
Rapid optimization of protein freeze drying
formulations using ultra scale down and factorial design of experiment in microplates. Biotechnol Bioeng 104:957–964
35. Bourles E, de Lannoy F, Scutella B, Fonseca F,
Trelea IC, Passot S (2019) Scale-up of freeze
drying cycles, the use of process analytical technology (PAT), and statistical analysis. In: Ward
KR, Matejtschuk P (eds) Lyophilization of
pharmaceuticals and biologicals: new technologies and approaches. Humana Press, Springer,
New York, pp 215–240
36. Cherry C (2019) Containment options for the
freeze-drying of biological entities and potent
materials. In: Ward KR, Matejtschuk P (eds)
Lyophilization of pharmaceuticals and biologicals: new technologies and approaches.
Humana Press, Springer, New York, pp
143–155
37. Schneid S, Gieseler H (2008) Evaluation of a
new wireless temperature remote interrogation
system (TEMPRIS) to measure product temperature during freeze drying. AAPS Pharm Sci
Tech 9:729–739
38. Tang C, Nail SL, Pikal MJ (2005) Freezedrying process design by manometric temperature measurement: design of a smart freezedryer. Pharm Res 22:685–700
39. Kessler WJ, Gong E (2019) Tunable diode
laser absorption spectroscopy in lyophilization.
In: Ward KR, Matejtschuk P (eds) Lyophilization of pharmaceuticals and biologicals: new
technologies and approaches. Humana Press,
Springer, New York, pp 113–141
40. Sylvester B, Porfire A, Van Bockstal P-J,
Porav S, Achim M, De Beer T, Tomut ¸a ˘ J
(2018) Formulation of long-circulating liposomes and in-line monitoring of the freezedrying process using a NIR spectroscopy tool.
J Pharm Sci 107:139–148
126
Kevin R. Ward and Paul Matejtschuk