journal article·2022-06-08Open access

Transfer Learning Analysis for Subvisible Particle Flow Imaging of Pharmaceutical Formulations

Xiangan Long, Chongjun Ma, Han Sheng, Liwen Chen, Yiyan Fei, Lan Mi, Dongmei Han, Jiong Ma

Applied Sciences· Volume 12· Issue 12

Abstract

Subvisible particles are an ongoing problem in biotherapeutic injectable pharmaceutical formulations, and their identification is an important prerequisite for tracing them back to their source and optimizing the process. Flow imaging microscopy (FIM) is a favored imaging technique, mainly because of its ability to achieve rapid batch imaging of subvisible particles in solution with excellent imaging quality. This study used VGG16 after transfer learning to identify subvisible particle images acquired using FlowCam. We manually prepared standards for seven classes of particles, acquired the image information through FlowCam, and fed the images over 5 µm into VGG16 consisting of a convolutional base of VGG16 pre-trained with ImageNet data and a custom classifier for training. An accuracy of 97.51% was obtained for the test set data. The study also demonstrated that the recognition method using transfer learning outperforms machine learning methods based on morphological parameters in terms of accuracy, and has a significant training speed advantage over scratch-trained CNN. The combination of transfer learning and FIM images is expected to provide a general and accurate data-analysis method for identifying subvisible particles.
Source: crossref · Quality: baseline

Research context

OpenAlex topics: Microfluidic and Bio-sensing Technologies · Electrical and Bioimpedance Tomography · Cell Image Analysis Techniques

SciVX discovery tags are terminology-based. OpenAlex topics are source-provided classifications.

Affiliations

Institute of Biomedical Engineering and Technology, Academy for Engineering and Technology, Fudan University, 220 Handan Road, Shanghai 200433, China

Process Development Downstream & Formulation, Shanghai Henlius Biotech, Inc., 1801 Hongmei Road, Shanghai 200233, China

Shanghai Engineering Research Center of Ultra-Precision Optical Manufacturing, Key Laboratory of Micro and Nano Photonic Structures (Ministry of Education), Green Photoelectron Platform, Department of Optical Science and Engineering, Fudan University, 220 Handan Road, Shanghai 200433, China

Ruidge Biotech Co., Ltd., Lin-Gang Special Area, China (Shanghai) Pilot Free Trade Zone, No. 888, Huanhu West 2nd Road, Shanghai 200131, China

Shanghai Engineering Research Center of Industrial Microorganisms, The Multiscale Research Institute of Complex Systems (MRICS), School of Life Sciences, Fudan University, 220 Handan Road, Shanghai 200433, China

Funding

National Key R&D Program of China · National Natural Science Foundation of China · Shanghai Natural Science Foundation · Science and Technology Research Program of Shanghai · Shanghai key discipline construction plan (2020–2022) · Shanghai Engineering Technology Research Center of Hair Medicine · Medical Engineering Fund of Fudan University · Fudan University

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