Huiquan Wu

Citation name

Wu, H.

State

MD

Country

USA

Huiquan Wu received his Ph.D. in Chemical Engineering with Minor in Materials Science and Engineering from Iowa State University in 2001. With over 20 years full-time working experience across academia, industry, and regulatory agency, he has been involved in a few major FDA initiatives (PAT, cGMP for the 21st Century, Pharmaceutical Inspectorate, QbD) designed to address challenges and opportunities related to pharmaceutical development, manufacturing, and quality assurance in an integrated system approach since 2002. He participated the FDA PAT Guidance drafting and finalizing process (2002-2004), organized and moderated a series of PAT/QbD sessions since 2004. His research interest includes pharmaceutical manufacturing science and chemo-metrics, pharmaceutical process control, application of various PAT tools to understand pharmaceutical unit operations. He published 29 peer-reviewed journal papers and 20 conference or society proceedings papers, and gave many invited talks at both international and national meeting. He is a co-inventor for 7 patents.

Sessions chaired or co-chaired

Advances in Drug Discovery Processes (Including HTE) Part 2

2016 AIChE Annual Meeting (ISBN: 978-0-8169-1097-7)

Advances in Drug Discovery Processes (including HTE)

2016 AIChE Annual Meeting (ISBN: 978-0-8169-1097-7)

Advances in Drug Discovery Processes (including HTE): Advanced Technology Approaches to Maximize Public Health Impacts

2017 Annual Meeting (ISBN: 978-0-8169-1102-8)

Advances in Drug Discovery Processes (including HTE): Protein Engineering Approaches with Target Therapeutic Applications

2017 Annual Meeting (ISBN: 978-0-8169-1102-8)

Control Strategies in Pharmaceutical Drug Product Development and Manufacturing

2017 Annual Meeting (ISBN: 978-0-8169-1102-8)

Critical Quality Attribute Monitoring and Control in Drug Substance Manufacturing I

2013 AIChE Annual Meeting (ISBN: 978-0-8169-1110-3)

Critical Quality Attribute Monitoring and Control in Drug Substance Manufacturing II

2018 AIChE Annual Meeting (ISBN: 978-0-8169-1108-0)

Critical Quality Attribute Monitoring and Control in Pharmaceutical Manufacturing I

2019 AIChE Annual Meeting (ISBN: 978-0-8169-1112-7)

Critical Quality Attribute Monitoring and Control in Pharmaceutical Manufacturing II

2020 Virtual AIChE Annual Meeting (ISBN: 978-0-8169-1114-1)

Critical Quality Attribute Monitoring and Control in Pharmaceutical Manufacturing III

2021 Annual Meeting (ISBN: 978-0-8169-1116-5)

Developing Process Control Strategies for Drug Substance Manufacture

2021 Annual Meeting (ISBN: 978-0-8169-1116-5)

Development of Pharmaceutical Process Control Strategies for Drug Product Manufacture

2022 Annual Meeting (ISBN: 978-0-8169-1118-9)

Enabling Technologies Relevant to Drug Substance and Drug Product I

2022 Annual Meeting (ISBN: 978-0-8169-1118-9)

Enabling Technologies Relevant to Drug Substance and Drug Product IV

2023 AIChE Annual Meeting (ISBN: 978-0-8169-1120-2)

Poster Session: Pharmaceutical Discovery, Development, and Manufacturing

2023 AIChE Annual Meeting (ISBN: 978-0-8169-1120-2)

QbD: Has It Delivered on the Promises?

2023 AIChE Annual Meeting (ISBN: 978-0-8169-1120-2)

Authored

(99f) Scientific Validation of THz Spectroscopic Measurement and Its Pharmaceutical Process Analytical Technology (PAT) Applications: Case Studies of First Principles Modeling Approach

Mansoor A. Khan

2012 AIChE Annual Meeting

(424g) Real Time PAT Monitoring of Bioreactor Mab IgG3 Cell Culture Process Dynamics Via Fourier Transform Infrared Spectroscopy: Implications and Challenges

2016 AIChE Annual Meeting (ISBN: 978-0-8169-1097-7)

(705b) Scientific Considerations and Regulatory Challenges for Low Dose Drug Manufacturing Process Monitoring and Control

Koushik Sowrirajan

2017 Annual Meeting (ISBN: 978-0-8169-1102-8)

(565b) Use of Process Analytical Technology (PAT) in Advanced Manufacturing Process Monitoring and Control: Scientific Considerations and Regulatory Challenges

2017 Annual Meeting (ISBN: 978-0-8169-1102-8)

(759c) Principal Component Analysis for Pharmaceutical Process and Product Characterization:Case Study From Immediate and Controlled Release Tablet Manufacturing

2013 AIChE Annual Meeting (ISBN: 978-0-8169-1110-3)

(406f) An Integrated PAT Approach for a Lab Scale Bioreactor IgG3 Cell Culture Process Real Time Monitoring: A Feasibility Study

2013 AIChE Annual Meeting (ISBN: 978-0-8169-1110-3)

(507e) Applying Dynamic Similarity Principles to a Narrow Therapeutic Index Drug Powder Blending Process Scale-up: Laboratory Case Studies and Relevant Regulatory Experience

Koushik Sowrirajan

Masihuddin Jaiqirdar

2018 AIChE Annual Meeting (ISBN: 978-0-8169-1108-0)

(260d) Process Control Strategy Development for a Challenging Drug Powder Blending Process Via Real-Time Process Analytical Technology (PAT) Monitoring and Prediction

Koushik Sowrirajan

2019 AIChE Annual Meeting (ISBN: 978-0-8169-1112-7)

(407a) Calibration-Free Approach for End-Point Determination of a Challenging Powder Blending Process: Scientific Case Study

Koushik Sowrirajan

2020 Virtual AIChE Annual Meeting (ISBN: 978-0-8169-1114-1)

(719a) CMC Sampling Considerations for Applying Enabling Technologies to Pharmaceutical Development and Manufacturing: Challenges and Opportunities

2021 Annual Meeting (ISBN: 978-0-8169-1116-5)

(81d) Prediction of Tablet Dissolution from Real-Time Optical Coherence Tomography Data

Maxwell Korang-Yeboah

Johannes G. Khinast

2022 Annual Meeting (ISBN: 978-0-8169-1118-9)

(372h) FDA Considerations on Soft Sensor Development and Implementation for Crystallinity Monitoring and Control Strategy in Pharmaceutical Manufacturing

2023 AIChE Annual Meeting (ISBN: 978-0-8169-1120-2)

Associated proceedings

2012 AIChE Annual Meeting

2016 AIChE Annual Meeting

2017 Annual Meeting

2013 AIChE Annual Meeting

2018 AIChE Annual Meeting

2019 AIChE Annual Meeting

2020 Virtual AIChE Annual Meeting

2021 Annual Meeting

2022 Annual Meeting

2023 AIChE Annual Meeting