Implemention of Innovative Process Analytical Technologies to Characterize Critical Quality Attributes of Co‐Formulated Monoclonal Antibody Products

IF 3.5 2区生物学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Biotechnology and Bioengineering Pub Date : 2024-11-08 DOI:10.1002/bit.28881

Apurva Godbole, Lyufei Chen, Jay Desai, Smita Raghava, Richard Ruzanski, Bhumit Patel, Emmanuel Appiah‐Amponsah, Hanzhou Feng

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Abstract

Characterizing co‐formulated monoclonal antibodies (mAbs) poses significant challenges in the pharmaceutical industry. Due to the high structural similarity of the mAbs, traditional analytical methods, compounded by the lengthy method development process, hinder product development and manufacturing efficiency. There is increasing critical need in the pharmaceutical industry to streamline analytical approaches, minimizing time and resources, ensuring a rapid clinical entry and cost‐effective manufacturing. This study investigates the application of process analytical technologies (PAT) to address such challenges. Our investigation introduces two complementary technologies, on‐line ultra‐performance liquid chromatography (online UPLC) and multimode fluorescence spectroscopy (MMFS), as potential PAT tools tailored for characterizing critical quality attributes (CQA) in co‐formulated mAb products. Specifically, the CQAs under evaluation include the total protein concentration of the mAbs within the co‐formulation and the ratio of mAb A to mAb B. Online UPLC enables direct and automated measurement of the CQAs through physical separation, while MMFS determines them in a non‐destructive and more swift manner based on chemometric modeling. We demonstrate these technologies' comparable performance to conventional methods, alongside substantial benefits such as reduced analytical turnaround time and decreased laboratory efforts. Ultimately, integrating them as innovative PAT tools expedites the delivery of therapeutic solutions to patients and enhances manufacturing efficiency, aligning with the imperative for swift translation of scientific discoveries into clinical benefits.

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采用创新工艺分析技术表征共配单克隆抗体产品的关键质量属性

共配制单克隆抗体（mAbs）的表征给制药行业带来了巨大挑战。由于 mAbs 的结构高度相似，传统的分析方法加上漫长的方法开发过程阻碍了产品开发和生产效率。制药行业越来越迫切需要简化分析方法，最大限度地减少时间和资源，确保产品快速进入临床并实现经济高效的生产。本研究调查了过程分析技术 (PAT) 在应对此类挑战中的应用。我们的研究引入了在线超高效液相色谱（UPLC）和多模荧光光谱（MMFS）这两种互补技术，作为潜在的 PAT 工具，专门用于表征共配制 mAb 产品的关键质量属性（CQA）。在线超高效液相色谱（UPLC）可通过物理分离直接自动测量 CQA，而多模式荧光光谱（MMFS）则基于化学计量建模以非破坏性和更快速的方式确定 CQA。我们展示了这些技术与传统方法相当的性能，以及缩短分析周转时间和减少实验室工作量等实质性优势。最终，将这些技术整合为创新的 PAT 工具，可加快向患者提供治疗方案并提高生产效率，这与将科学发现迅速转化为临床效益的要求不谋而合。

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来源期刊

Biotechnology and Bioengineering 工程技术-生物工程与应用微生物

CiteScore

7.90

自引率

5.30%

发文量

280

审稿时长

2.1 months

期刊介绍： Biotechnology & Bioengineering publishes Perspectives, Articles, Reviews, Mini-Reviews, and Communications to the Editor that embrace all aspects of biotechnology. These include: -Enzyme systems and their applications, including enzyme reactors, purification, and applied aspects of protein engineering -Animal-cell biotechnology, including media development -Applied aspects of cellular physiology, metabolism, and energetics -Biocatalysis and applied enzymology, including enzyme reactors, protein engineering, and nanobiotechnology -Biothermodynamics -Biofuels, including biomass and renewable resource engineering -Biomaterials, including delivery systems and materials for tissue engineering -Bioprocess engineering, including kinetics and modeling of biological systems, transport phenomena in bioreactors, bioreactor design, monitoring, and control -Biosensors and instrumentation -Computational and systems biology, including bioinformatics and genomic/proteomic studies -Environmental biotechnology, including biofilms, algal systems, and bioremediation -Metabolic and cellular engineering -Plant-cell biotechnology -Spectroscopic and other analytical techniques for biotechnological applications -Synthetic biology -Tissue engineering, stem-cell bioengineering, regenerative medicine, gene therapy and delivery systems The editors will consider papers for publication based on novelty, their immediate or future impact on biotechnological processes, and their contribution to the advancement of biochemical engineering science. Submission of papers dealing with routine aspects of bioprocessing, description of established equipment, and routine applications of established methodologies (e.g., control strategies, modeling, experimental methods) is discouraged. Theoretical papers will be judged based on the novelty of the approach and their potential impact, or on their novel capability to predict and elucidate experimental observations.