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Bio Summary:

Xin Jin is a highly accomplished professional with a background in Chemical Engineering and extensive experience in the pharmaceutical and research industries. With a Ph.D. in Chemical Engineering from Ohio University, Xin has contributed significantly to the fields of drug product development, analytical method validation, and process engineering. Xin’s expertise encompasses a wide range of areas, including AAV drug product development, lipid nano particle (LNP) drug development, and high concentration protein product platform development.

Title: Freeze Drying and Vial Breakage: Misconceptions, Root Causes, and Mitigation Strategies for the Pharmaceutical Industry

Abstract:

Vial breakage during or following freeze drying (lyophilization) is a well-known phenomenon in the pharmaceutical industry, yet the underlying mechanism and root causes are not well characterized. While commonly attributed to crystallizing excipients like mannitol, other potential factors are often underestimated or not well studied. This research presents a systematic multipronged approach to characterize and identify potential root causes of vial breakage during lyophilization.

Key Points:

Multipronged Approach: The study employs a systematic and comprehensive approach, considering various factors associated with formulation, product configuration, primary container, and production process stress conditions.

Laboratory and Manufacturing Scale Studies: Investigations are conducted both at the laboratory and manufacturing scales to provide a holistic understanding of the vial breakage phenomenon.

Factors Investigated:

Strain gauge and lyophilization analysis for stress on glass vials with different formulation conditions and fill volumes.

Manufacturing fill-finish process risk assessment, including loading and frictive force impact on the vials.

Glass vial design and ruggedness, involving glass compression resistance or burst strength testing.

Complexity of Vial Breakage Causes: No single factor could be independently related to the extent of vial breakage observed during production. Instead, a combination of formulation, fill volume, and at-scale production processes were identified as the most probable root causes.

Identification of Probable Root Causes:

Formulation

Fill volume

Vial weakening processes encountered during at-scale production, such as vial handling, shelf loading, and unloading.

Contradiction to Simplistic Explanations: The study challenges simplistic root-cause explanations reported in literature and emphasizes the need for a more nuanced understanding of vial breakage.

Mitigative Approaches: The research provides insights into the possibility of implementing mitigative approaches to minimize or eliminate vial breakage associated with lyophilized drug products.

Education:

• Ph.D. Chemical Engineering, Ohio University, September 2009
• M.S. Physical Chemistry, University of Science and Technology, Beijing, March 2001
• B.S. Chemical Engineering, Beijing Institute of Petrochemical Technology, August 1998

Research Focus:

Xin Jin’s research has focused on various aspects of chemical engineering, including coal electrolysis for hydrogen production, electrochemical analytical methods, and the design and application of Z-Path Moving Bed (ZMB) in drying and dust removal processes. The research has resulted in publications and patents, showcasing Xin’s commitment to advancing scientific knowledge.

Professional Journey:

Xin Jin has held key roles in prominent organizations, including Sanofi, Fresenius Kabi, Shire Pharmaceuticals, and Armstrong Pharmaceutical Inc. The roles have spanned from Research Engineer to Scientist in BioDrug Product Development, highlighting Xin’s versatility and leadership in areas such as formulation studies, lyophilization process modeling, and analytical method development.

Publications Top Noted & Contributions:

Xin Jin has made significant contributions to the field, with notable publications such as “Understanding the Kinetics of Coal Electrolysis at Intermediate Temperatures” and “Feasibility of Hydrogen Production from Coal Electrolysis at Intermediate Temperatures.” Additionally, Xin has a patent pending for an electrochemical technique to measure the concentration of multivalent cations simultaneously.

Understanding the kinetics of coal electrolysis at intermediate temperatures” (Journal of Power Sources, 2010, 195(15), pp. 4935–4942)

• 54 Citations

“Electrochemical technique to measure Fe(II) and Fe(III) concentrations simultaneously” (Journal of Applied Electrochemistry, 2009, 39(10), pp. 1709–1717)

• 15 Citations

“Fuel Cells – Exploratory Fuel Cells | Direct Carbon Fuel Cells” (Encyclopedia of Electrochemical Power Sources, 2009, pp. 158–171)

• 15 Citations

“Feasibility of hydrogen production from coal electrolysis at intermediate temperatures” (Journal of Power Sources, 2007, 171(2), pp. 826–834)

• 47 Citations

Author Metrics:

• Total documents: 4
• Cited by 94 documents
• h-index: 4

Research Timeline:

• Research Assistant, Electrochemical Engineering Research Laboratory, Ohio University (March 2005 to September 2009)
  • Dissertation Project: Feasibility of coal electrolysis to produce hydrogen at intermediate temperatures.
• Research Assistant, Institute of Process Engineering, Chinese Academy of Sciences (September 1998 to March 2001)
  • Master’s Project: Z-Path Moving Bed (ZMB) Design and its Application in Drying and Dust Removal Process.
• Quality Testing Lab Manager, Beijing University Pioneer Technology Company, Ltd. (September 2002 to March 2003)
• Process Engineer, Beijing University Pioneer Technology Company, Ltd. (March 2001 to March 2003)