Best Practices and Guidelines (2022) for Scale-Up and Tech Transfer in Freeze-Drying Based on Case Studies. Part 1: Challenges during Scale Up and Transfer.

Autor: Tchessalov S; Pfizer Inc., Andover, Massachusetts, USA., Shalaev E; AbbVie, Irvine, California, USA., Bhatnagar B; Pfizer Inc., Andover, Massachusetts, USA., Nail S; West Lafayette, California, USA., Alexeenko A; Birck Nanotechnology Center, Purdue University, 1205 W State St, West Lafayette, California, 47907, USA., Jameel F; Gilead Sciences, Plaines, Morris, New Jersey, USA., Srinivasan J; Baxter, Bloomington, Indiana, USA., Dekner M; Takeda Pharmaceutical Company, Vienna, Austria., Sahni E; Regeneron Inc., Troy, New York, USA., Schneid S; Bayer, Westphalia, Wuppertal, Germany., Kazarin P; Birck Nanotechnology Center, Purdue University, 1205 W State St, West Lafayette, California, 47907, USA. pkazarin@purdue.edu., McGarvey O; Lonza AG, Basel, Switzerland., Van Meervenne B; Pfizer Inc., Temse, Belgium., Kshirsagar V; IMA Life, Tonawanda, New York, USA., Pande P; Merck & Co., Inc., Rahway, New Jersey, USA., Philipp J; OPTIMA Pharma, Gladenbach, Hessen, Germany., Sacha G; Baxter, Bloomington, Indiana, USA., Wu K; AbbVie, Irvine, California, USA., Azzarella J; Fresenius Kabi, Grand Island, New York, USA., Shivkumar G; AbbVie Inc., North Chicago, Illinois, USA., Bhatt S; OPTIMA Pharma, Gladenbach, Hessen, Germany.
Jazyk: angličtina
Zdroj: AAPS PharmSciTech [AAPS PharmSciTech] 2022 Nov 30; Vol. 24 (1), pp. 11. Date of Electronic Publication: 2022 Nov 30.
DOI: 10.1208/s12249-022-02463-x
Abstrakt: The freeze-drying process scale-up and transfer remain a complicated and non-uniform practice. We summarized inefficient and good practices in these papers and provided some practical advice. It was demonstrated that using the same process set points/times in laboratory and commercial scale dryers may lead to loss of product quality (collapse or vial breakage). The emerging modeling approach demonstrated practical advantages. However, the upfront generation of some input parameters (vial heat transfer coefficient, minimum controllable pressure, and maximum sublimation rate) is essential for model utilization. While the primary drying step can be transferred with a high degree of confidence (e.g., using modeling), and secondary drying is usually fairly straightforward, predicting potential changes in product behavior during freezing remains challenging.
(© 2022. The Author(s).)
Databáze: MEDLINE
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