Roadmap for Drug Product Development and Manufacturing of Biologics

Krishnan Sampathkumar, Bruce A.Kerwin; Journal of Pharmaceutical Sciences 113 (2024) 314−331.

Practical Advice on Scientific Design of Freeze‑Drying Process: 2023 Update

Tchessalov et al. Pharm Res 40, 2433–2455 (2023).

Technical transfer and commercialisation of lyophilised biopharmaceuticals — application of lyophiliser characterisation and comparability

Cullen et al. AAPS Open (2022) 8:14

Mannitol as an Excipient for Lyophilized Injectable Formulations

Thakral, et. al.;  Journal of Pharmaceutical Sciences 112 (2023) 1935

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

Tchessalov, et. al.; AAPS PharmSciTech volume 24, Article number: 11 (2023)

Best Practices and Guidelines (2022) for Scale‐up and Technology Transfer in Freeze Drying Based on Case Studies. Part 2: Past Practices, Current Best Practices, and Recommendations

Tchessalov, et. al.; AAPS PharmSciTech volume 24, Article number: 96 (2023)

Equipment Capability Measurement of Laboratory Freeze-Dryers: a Comparison of Two Methods

Srinivasan, et. al.; AAPS PharmSciTech volume 22, Article number: 53 (2021)

The graphical design space for the primary drying phase of freeze Drying: Factors affecting the dried product layer resistance

Srinivasan, et. al.; International Journal of Pharmaceutics, Volume 630, 5 January 2023, 122417


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