Q&A Released with Bristol-Myers Squibb in the Run-up to Pharmaceutical Freeze Drying Technology 2017
Interview released with freeze drying expert and leading author, Dr Xiaodong Chen, Senior Research Investigator, Bristol-Myers Squibb
Xiaodong Chen is currently developing innovative computational models and applying them to pharmaceutical processes such as powder compaction, freeze drying, and fill/finish manufacturing of late stage candidates for both oral dosage forms and sterile/non sterile liquid formulations. He is a key driver leading the efforts of implementing models to reduce and optimize freeze drying cycles of commercial and late stage biologics drugs at BMS.
When asked about current challenges in freeze drying and scale-up, Dr Chen said:
“As the biologics industry continues to grow exponentially, marked by an increase in BLA submitted for approval, there will more and more biologics drug products in the manufacturing stage. Manufacturing capabilities could be one of the challenges that our industry faces. How to develop innovative lyophilisation technologies and further reduce/optimize cycles would be critical to pharma industry.”
“Manufacturing scale up is often a key element of a larger technology transfer project from lab scale to clinical manufacturing, commercial manufacturing or CMO. Even though every company has their own scale up strategy and procedures, there is still a lot riding on their successful implementation. Understanding equipment differences and their impact on process, difficulty to place thermocouples in the production unit and identifying end of primary drying still remain challenging.”
With a focus on leveraging a model based approach to design and optimise lyophilisation processes at different stages, his talk at Pharmaceutical Freeze Drying Technology 2017 will explore:
• Leveraging Design of Experiments (DOE) to develop statistical models for both formulation and process parameters at early stages
• Integrate model and experimental approaches to enable robustness at mid stage
• Provide guidance on process optimisation to enable efficiency through measuring commercial equipment capabilities at late stage
The full interview is available to read in the event download centre.
Further information including a detailed agenda and full speaker line-up is available at www.pharmafreezedrying.com
Pharmaceutical Freeze Drying Technology
5th Annual Conference: 8th & 9th May
Copthorne Tara Hotel, London, UK
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