Acknowledgments
The authors would like to acknowledge colleagues at Biopharma
Process Systems and NIBSC for their input and discussion to this
chapter.
References
1. Fanget B, Francon A (1996) A Varicella vaccine
stable at 5
C. Dev Biol Stand 87:167–171
2. Adams GDJ (1995) The preservation of
inocula. In: Brown MRW, Gilbert P (eds)
Microbiological quality assurance: a guide
towards relevance and reproducibility of
inocula. CRC Press, London, pp 89–119
3. Hansen LJ, Daoussi R, Vervaet C, Remon JP,
De Beer TR (2015) Freeze-drying of live virus
vaccines: a review. Vaccine 33:5507–5519
4. Bindschaedler C (1999) Lyophilization process validation. In: Rey L, May JC (eds)
Freeze-drying/lyophilization of pharmaceutical and biological products. Marcel Dekker,
New York, pp 373–408
5. Liapis AI, Sadikoglu H (1997) Mathematical
modeling of the primary and secondary drying
stages of bulk solution freeze-drying in trays:
parameter estimation and model discrimination by comparison of the theoretical results
with experimental data. Dry Technol
15:791–810
6. McAndrew TP, Hostetler D, FL DG (2019)
Container and reconstitution systems for lyophilized drug products. In: Ward KR,
Matejtschuk P (eds) Lyophilization of pharmaceuticals and biologicals: new technologies and
approaches.
Humana
Press,
Springer,
New York, pp 193–214
7. Carpenter JF, Izutsu K-I, Randolph T (2010)
Freezing- and drying- induced perturbations
of protein structure and mechanisms of protein
protection by stabilizing additives. In: Rey L,
May JC (eds) Freeze-drying/lyophilization of
pharmaceutical and biological products, 3rd
edn. Informa Healthcare, New York, pp
167–197
8. Adebayo AA, Sim-Brandenburg JW, Emmel H,
Olaeye DO, Niedrig M (1998) Stability of 17D
yellow fever virus vaccine using different stabilisers. Biologicals 26:309–316
9. Matejtschuk P, Malik K, Duru C (2019) Formulation and process development for lyophilized biological reference materials. In: Ward
KR, Matejtschuk P (eds) Lyophilization of
pharmaceuticals and biologicals: new technologies and approaches. Humana Press, Springer,
New York, pp 33–55
10. Searles JA (2010) Freezing and annealing phenomena in lyophilization. In: Rey L, May JC
(eds) Freeze-drying/lyophilization of pharmaceutical and biological products, 3rd edn.
Informa Healthcare, New York, pp 52–81
11. Ward KR, Matejtschuk P (2019) Characterization of formulations for freeze drying. In: Ward
KR, Matejtschuk P (eds) Lyophilization of
pharmaceuticals and biologicals: new technologies and approaches. Humana Press, Springer,
New York, pp 1–32
12. Luoma J, Magill G, Kumar L, Yusoff Z (2019)
Controlled ice nucleation using ControLyo
®
pressurization-depressurization method. In:
Ward KR, Matejtschuk P (eds) Lyophilization
of pharmaceuticals and biologicals: new technologies and approaches. Humana Press,
Springer, New York, pp 57–77
13. Pisano (2019) Alternative methods of
controlling nucleation in freeze drying. In:
Ward KR, Matejtschuk P (eds) Lyophilization
of pharmaceuticals and biologicals: new technologies and approaches. Humana Press,
Springer, New York, pp 79–111
14. Bhatnagar BS, Pikal MJ, Bogner RH (2007)
Study of the individual contributions of ice
formation and freeze-concentration on isothermal stability of lactate dehydrogenase during
freezing. J Pharm Sci 97:798–814
15. Awotwe-Otoo D, Agarabi C, Read EK, Lute S,
Brorson KA, Khan MA, Shah RB (2013)
Impact of controlled ice nucleation on process
performance and quality attributes of a lyophilized monoclonal antibody. Int J Pharm
450:70–78
16. Oddone I, Arsiccio A, Duru C, Malik K,
Ferguson J, Pisano R, Matejtschuk P (2019)
Vacuum-induced surface freezing for the
freeze-drying of the human growth hormone:
how does nucleation control affect protein stability? J Pharm Sci. https://doi.org/10.1016/
j.xphs.2019.04.014
17. Geidobler R, Winter G (2013) Controlled ice
nucleation in the field of freeze-drying: fundamentals and technology review. Eur J Pharm
Biopharm 85:214–222
18. Patel SM, Nail SL, Pikal MJ, Geidobler R,
Winter G, Hawe A, Davagnino J, Gupta SR
Principles of Freeze-Drying
125
The authors would like to acknowledge colleagues at Biopharma
Process Systems and NIBSC for their input and discussion to this
chapter.
References
1. Fanget B, Francon A (1996) A Varicella vaccine
stable at 5
C. Dev Biol Stand 87:167–171
2. Adams GDJ (1995) The preservation of
inocula. In: Brown MRW, Gilbert P (eds)
Microbiological quality assurance: a guide
towards relevance and reproducibility of
inocula. CRC Press, London, pp 89–119
3. Hansen LJ, Daoussi R, Vervaet C, Remon JP,
De Beer TR (2015) Freeze-drying of live virus
vaccines: a review. Vaccine 33:5507–5519
4. Bindschaedler C (1999) Lyophilization process validation. In: Rey L, May JC (eds)
Freeze-drying/lyophilization of pharmaceutical and biological products. Marcel Dekker,
New York, pp 373–408
5. Liapis AI, Sadikoglu H (1997) Mathematical
modeling of the primary and secondary drying
stages of bulk solution freeze-drying in trays:
parameter estimation and model discrimination by comparison of the theoretical results
with experimental data. Dry Technol
15:791–810
6. McAndrew TP, Hostetler D, FL DG (2019)
Container and reconstitution systems for lyophilized drug products. In: Ward KR,
Matejtschuk P (eds) Lyophilization of pharmaceuticals and biologicals: new technologies and
approaches.
Humana
Press,
Springer,
New York, pp 193–214
7. Carpenter JF, Izutsu K-I, Randolph T (2010)
Freezing- and drying- induced perturbations
of protein structure and mechanisms of protein
protection by stabilizing additives. In: Rey L,
May JC (eds) Freeze-drying/lyophilization of
pharmaceutical and biological products, 3rd
edn. Informa Healthcare, New York, pp
167–197
8. Adebayo AA, Sim-Brandenburg JW, Emmel H,
Olaeye DO, Niedrig M (1998) Stability of 17D
yellow fever virus vaccine using different stabilisers. Biologicals 26:309–316
9. Matejtschuk P, Malik K, Duru C (2019) Formulation and process development for lyophilized biological reference materials. In: Ward
KR, Matejtschuk P (eds) Lyophilization of
pharmaceuticals and biologicals: new technologies and approaches. Humana Press, Springer,
New York, pp 33–55
10. Searles JA (2010) Freezing and annealing phenomena in lyophilization. In: Rey L, May JC
(eds) Freeze-drying/lyophilization of pharmaceutical and biological products, 3rd edn.
Informa Healthcare, New York, pp 52–81
11. Ward KR, Matejtschuk P (2019) Characterization of formulations for freeze drying. In: Ward
KR, Matejtschuk P (eds) Lyophilization of
pharmaceuticals and biologicals: new technologies and approaches. Humana Press, Springer,
New York, pp 1–32
12. Luoma J, Magill G, Kumar L, Yusoff Z (2019)
Controlled ice nucleation using ControLyo
®
pressurization-depressurization method. In:
Ward KR, Matejtschuk P (eds) Lyophilization
of pharmaceuticals and biologicals: new technologies and approaches. Humana Press,
Springer, New York, pp 57–77
13. Pisano (2019) Alternative methods of
controlling nucleation in freeze drying. In:
Ward KR, Matejtschuk P (eds) Lyophilization
of pharmaceuticals and biologicals: new technologies and approaches. Humana Press,
Springer, New York, pp 79–111
14. Bhatnagar BS, Pikal MJ, Bogner RH (2007)
Study of the individual contributions of ice
formation and freeze-concentration on isothermal stability of lactate dehydrogenase during
freezing. J Pharm Sci 97:798–814
15. Awotwe-Otoo D, Agarabi C, Read EK, Lute S,
Brorson KA, Khan MA, Shah RB (2013)
Impact of controlled ice nucleation on process
performance and quality attributes of a lyophilized monoclonal antibody. Int J Pharm
450:70–78
16. Oddone I, Arsiccio A, Duru C, Malik K,
Ferguson J, Pisano R, Matejtschuk P (2019)
Vacuum-induced surface freezing for the
freeze-drying of the human growth hormone:
how does nucleation control affect protein stability? J Pharm Sci. https://doi.org/10.1016/
j.xphs.2019.04.014
17. Geidobler R, Winter G (2013) Controlled ice
nucleation in the field of freeze-drying: fundamentals and technology review. Eur J Pharm
Biopharm 85:214–222
18. Patel SM, Nail SL, Pikal MJ, Geidobler R,
Winter G, Hawe A, Davagnino J, Gupta SR
Principles of Freeze-Drying
125