Article
Food Science & Technology
Eva M. Achata, Carlos Esquerre, K. Shikha Ojha, Brijesh K. Tiwari, Colm P. O'Donnell
Summary: In this study, beef jerky samples were dried under different conditions with and without ultrasound treatment, and their moisture content was predicted using near infrared hyperspectral imaging and chemometrics. The developed moisture content prediction models show potential for process control applications, with different optimal models for ultrasound treated and non-treated samples.
INNOVATIVE FOOD SCIENCE & EMERGING TECHNOLOGIES
(2021)
Article
Engineering, Chemical
Alex Juckers, Petra Knerr, Frank Harms, Jochen Strube
Summary: Lyophilization is commonly used for preserving thermolabile products, with the main drawback being the long processing time. By implementing the quality by design (QbD) approach and process analytical technology (PAT), the process duration can be optimized for increased productivity while maintaining product safety.
Article
Food Science & Technology
Silvia Grassi, Lorenzo Strani, Cristina Alamprese, Nicolo Pricca, Ernestina Casiraghi, Giovanni Cabassi
Summary: This study proposes a process analytical technology approach using near infrared spectroscopy and multivariate statistical process control charts for the control of milk coagulation. The results demonstrate the effectiveness of this method in monitoring coagulation times and detecting possible failures.
Article
Food Science & Technology
Jakob Forsberg, Per Munk Nielsen, Soren Balling Engelsen, Klavs Martin Sorensen
Summary: Enzymatic degumming is an established process in vegetable oil refinement that offers higher oil yield and more stable downstream processing compared to traditional methods. This study explores the use of Near-Infrared spectroscopy (NIRS) to monitor the enzymatic degumming reaction and proposes a new method to balance spectral noise and maintain chemical information. The optimal Partial Least Squares (PLS) model includes eight wavelength variables and yields an RMSECV of 0.05% free fatty acid using five latent variables, demonstrating the potential for accurate monitoring and prediction of the process.
Article
Engineering, Chemical
Alex Juckers, Petra Knerr, Frank Harms, Jochen Strube
Summary: This paper introduces the application of emerging process analytical technology in freeze-drying process and outlines their potential for implementation in a control strategy.
Article
Chemistry, Analytical
Gabriella Gerzon, Yi Sheng, Marina Kirkitadze
Summary: Process Analytical Technology (PAT) instruments optimize process controls by measuring parameters and attributes in real time, mainly applied in pharmaceutical manufacturing. PAT solutions aim to achieve quality control and real-time product release, promoting production efficiency and reducing production costs.
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
(2022)
Article
Biotechnology & Applied Microbiology
Christopher Gillespie, Dhanuka P. Wasalathanthri, Diana B. Ritz, George Zhou, Keith A. Davis, Thomas Wucherpfennig, Nadine Hazelwood
Summary: The study evaluated the business value of PAT technologies in biotherapeutic development, highlighting the different values various PAT tools hold in upstream and downstream processes. The results aim to assist current practitioners and newcomers in prioritizing and steering their projects towards success.
BIOTECHNOLOGY AND BIOENGINEERING
(2022)
Article
Pharmacology & Pharmacy
Adam J. J. Rish, Samuel R. R. Henson, Yang Liu, James K. K. Drennen, Carl A. A. Anderson, Md. Anik Alam
Summary: As continuous manufacturing processes develop, near-infrared spectroscopy has become an important tool in process monitoring. Traditional Partial Least Squares (PLS) models require significant time and resources for development, leading to the increasing interest in calibration-free/minimal calibration approaches. This study demonstrates the success and value of iterative optimization technology algorithms for monitoring potency trends and API content in a continuous manufacturing system, with improved prediction performance using a novel wavelength method.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2022)
Review
Chemistry, Applied
E. J. Rifna, R. Pandiselvam, Anjineyulu Kothakota, K. V. Subba Rao, Madhuresh Dwivedi, Manoj Kumar, Rohit Thirumdas, S. V. Ramesh
Summary: The combination of process analytical tools with chemometrics provides a powerful technique for identifying adulterants in edible oils, with applications in quality monitoring, geographic origin assessment, process evaluation, and product categorization.
Review
Biochemistry & Molecular Biology
Tibor Casian, Brigitta Nagy, Bela Kovacs, Dorian Laszlo Galata, Edit Hirsch, Attila Farkas
Summary: The FDA's guidance on Process Analytical Technology has spurred the pharmaceutical industry to adopt advanced analytical sensors and chemometric tools for improved drug quality. This survey evaluates the challenges and opportunities of implementing data fusion within the PAT concept and discusses its integration with Pharma 4.0.
Article
Chemistry, Analytical
Geetanjali Basavaraj Hubli, Shantanu Banerjee, Anurag S. Rathore
Summary: In this study, a robust FT-NIR based quantification method has been developed for the measurement of all 20 amino acids, glucose, lactate, and trastuzumab in CHO cell culture. The method achieved good calibration statistics and demonstrated the ability to accurately predict the concentrations of these components. The proposed tool has the potential to play a critical role in biopharmaceutical manufacturing and process control.
Review
Chemistry, Multidisciplinary
G. Gullifa, L. Barone, E. Papa, A. Giuffrida, S. Materazzi, R. Risoluti
Summary: There is a growing interest in cost-effective and nondestructive analytical techniques, and portable near-infrared spectrometers have been recognized as powerful instruments for nondestructive, online, or in situ analysis. Chemometrics plays a fundamental role in obtaining useful results from NIR spectra. This review provides starting references of portable NIR applications in the period 2019-2022 to demonstrate the potential of this analytical approach.
FRONTIERS IN CHEMISTRY
(2023)
Article
Biotechnology & Applied Microbiology
Vishwanath Hebbi, Garima Thakur, Anurag S. Rathore
Summary: This study utilized a combined spectroscopic and statistical approach to monitor and control the PEGylation reaction for G-CSF using near infrared spectroscopy (NIRS). The online NIRS probe tracked the conversion of G-CSF into different PEGylated forms in real time, while the spectra were used to build a batch evolution model and detect deviations. The system successfully identified and corrected four common deviations in the PEGylation process, demonstrating the potential for quality by design framework in biotechnology manufacturing.
JOURNAL OF BIOTECHNOLOGY
(2021)
Review
Chemistry, Analytical
Celia Carrillo, Igor B. Tomasevic, Francisco J. Barba, Senem Kamiloglu
Summary: This review discusses the use of modern analytical techniques for berry authentication, indicating that chemical approaches have been the main focus of studies to date. However, other chemical, biomolecular, and isotopic methods have also shown promising results. Combinations of different approaches are increasingly used to complement each other. Continuous research in the field of food authentication is needed, especially for berries, given their importance and the evolving adulteration practices.
Article
Biotechnology & Applied Microbiology
Jay M. West, Hasin Feroz, Xia Xu, Neha Puri, Melissa Holstein, Sanchayita Ghose, Julia Ding, Z. J. Li
Summary: Process analytical technology (PAT) is a rapidly growing field in bioprocessing that enables innovation in biological drug manufacturing. This study demonstrates novel PAT methods for monitoring multiple quality attributes during the UF/DF process operation and shows that single-use TFF cassettes are functionally equivalent to standard reusable cassettes, with online PAT measurements comparable to offline methods.
BIOTECHNOLOGY AND BIOENGINEERING
(2021)
Article
Endocrinology & Metabolism
Gayatri Vishwakarma, Neh Nupur, Anurag S. Rathore
Summary: In this study, the structural and functional similarity of biosimilars of insulin glargine were evaluated. The results showed that some biosimilars had higher levels of high molecular weight species and related substances, as well as higher rates of impurity generation. The aggregation at 14 days was found to be correlated with the aggregation at 0 day and the number of months from expiry. Overall, insulin glargine biosimilars demonstrated similarity to the innovator product, but certain biosimilars exhibited low amounts of product-related variants that impacted product stability. The order of biosimilarity was Lantus((R)) > Biosimilar 2 > Biosimilar 4 > Biosimilar 1 > Biosimilar 3.
JOURNAL OF DIABETES SCIENCE AND TECHNOLOGY
(2023)
Article
Pharmacology & Pharmacy
Anurag S. Rathore, Yuexia Li, Hemlata Chhabra, Akshat Lohiya
Summary: This study examines the reasons for warning letters issued by the FDA to pharmaceutical companies after post-approval inspections. The most common reasons for the warning letters are poor compliance to CGMP and misbranding. Detailed analysis of CGMP warning letters reveals three major types of violations: deficiencies in process validation, documentation practices (data integrity), and quality control. The study emphasizes the importance of improving CGMP compliance and implementing effective quality management systems to avoid warning letters.
JOURNAL OF PHARMACEUTICAL INNOVATION
(2023)
Review
Biotechnology & Applied Microbiology
Anurag S. Rathore, Garima Thakur, Nikhil Kateja
Summary: Continuous integrated bioprocessing has gained significant attention from the biopharma industry, but its implementation in the biologics industry faces challenges due to legacy infrastructure, regulatory guidelines, and a focus on novel therapies. This article provides a review and perspective on the status and hurdles of continuous integrated bioprocessing. It suggests that the real impact of this technology may be seen when manufacturing costs become a significant portion of product development costs.
BIOTECHNOLOGY AND BIOENGINEERING
(2023)
Review
Biotechnology & Applied Microbiology
Anurag S. Rathore, Saxena Nikita, Garima Thakur, Somesh Mishra
Summary: Artificial intelligence and machine learning have vast potential in optimizing the design, monitoring, and control of biopharmaceutical manufacturing. The driving forces for adopting these techniques include the increasing global demand for biotherapeutics and the rise of Industry 4.0, which require intelligent, automated supervision. This review summarizes the applications of artificial intelligence and machine learning in biopharmaceutical manufacturing, focusing on commonly used algorithms such as multivariate data analysis, artificial neural networks, and reinforcement learning. Perspectives on the future growth of these applications and the challenges in implementing them at manufacturing scale are also discussed.
TRENDS IN BIOTECHNOLOGY
(2023)
Article
Biotechnology & Applied Microbiology
Rajinder Kaur, Ritu Jain, Niharika Budholiya, Anurag S. Rathore
Summary: The study investigates the impact of long term culturing on cell morphology and altered cellular functions, which may lead to phenotypic drift and affect product yield and quality. The study highlights the use of cellular and analytical assay toolbox to define cell line stability and optimize culture performance and product quality.
BIOTECHNOLOGY LETTERS
(2023)
Article
Biochemical Research Methods
Ramesh Kumar, Deepika Sarin, Anurag S. S. Rathore
Summary: The complexity of biotherapeutic products requires monitoring and characterization of numerous product quality attributes. Capillary electrophoresis (CE) has been used in biopharmaceutical analysis but is considered low-throughput. In this study, the dead time of CE was utilized to analyze three monoclonal antibody samples, resulting in a significant reduction in analysis time and increased productivity without compromising resolution. Good method reproducibility was observed, suggesting that sequential injections can be applied for fast and robust CE analysis of biopharmaceuticals.
Review
Pharmacology & Pharmacy
Ritu Jain, Janakiraman Subramanian, Anurag S. Rathore
Summary: The drug approval process involves extensive and expensive preclinical and clinical examination. Most drugs fail in late-stage clinical trials due to inability to achieve primary endpoints or intolerable adverse effects. Only one-tenth of the drugs that enter clinical trials progress to FDA regulatory submission.
EXPERT OPINION ON PHARMACOTHERAPY
(2023)
Article
Biotechnology & Applied Microbiology
Rajinder Kaur, Anurag S. Rathore
Summary: This study demonstrates that the addition of antioxidants in cell culture can reduce ROS levels, increase mitochondrial membrane potential, improve cell viability, reduce apoptosis and lysosome activity. Furthermore, antioxidants can enhance antibody production and improve its quality.
JOURNAL OF CHEMICAL TECHNOLOGY AND BIOTECHNOLOGY
(2023)
Article
Chemistry, Analytical
Anuj Shrivastava, Shyamapada Mandal, Sudip K. Pattanayek, Anurag S. Rathore
Summary: Aggregation of monoclonal antibody therapeutics is a serious concern. A new approach using dynamic light scattering (DLS) and machine learning (ML) algorithm is proposed to quantify the relative percentage of multimers in a monoclonal antibody therapeutic product.
ANALYTICAL CHEMISTRY
(2023)
Review
Biotechnology & Applied Microbiology
Saxena Nikita, Somesh Mishra, Keshari Gupta, Venkataramana Runkana, James Gomes, Anurag S. Rathore
Summary: Advanced control strategies have been widely implemented in chemical, pharmaceutical, and food processing industries. Recently, there has been exploration of applying these strategies to bioreactor control for the production of biotherapeutics. The development of a robust and advanced process control system, aided by advancements in sensors, machinery, and industrial internet of things, can greatly improve bioreactor process performance, productivity, and reproducibility. This review discusses the advancements, challenges, and future prospects for control strategies in industrial-scale production of biotherapeutic products.
BIOTECHNOLOGY AND BIOENGINEERING
(2023)
Article
Medicine, Research & Experimental
Shravan Sreenivasan, Anurag S. Rathore
Summary: This study investigated the aggregation of mAb in the presence of Fe2+ and H2O2 in saline and in vitro models. The results showed that the combined presence of Fe2+ and H2O2 increased mAb aggregation and altered protein structure and hydrophobicity. Increasing the time, temperature, and Fe2+ and H2O2 concentration further enhanced mAb aggregation. Additionally, mAb samples with copper and cobalt chlorides also resulted in degradation.
MOLECULAR PHARMACEUTICS
(2023)
Article
Biochemistry & Molecular Biology
Akshay Chenna, Wajihul Hasan Khan, Rozaleen Dash, Saurabh Saraswat, Archana Chugh, Anurag S. Rathore, Gaurav Goel
Summary: This study used a structural bioinformatics protocol to design peptides that can inhibit the complexation of SARS-CoV-2 RdRp. Two designed peptides with high geometric complementarity and interaction specificity for the binding interface of nsp7 were identified. These peptides showed better binding affinity than nsp12 and effectively inhibited the complexation of nsp7-nsp12.
PROTEINS-STRUCTURE FUNCTION AND BIOINFORMATICS
(2023)
Article
Chemistry, Analytical
Geetanjali Basavaraj Hubli, Shantanu Banerjee, Anurag S. Rathore
Summary: In this study, a robust FT-NIR based quantification method has been developed for the measurement of all 20 amino acids, glucose, lactate, and trastuzumab in CHO cell culture. The method achieved good calibration statistics and demonstrated the ability to accurately predict the concentrations of these components. The proposed tool has the potential to play a critical role in biopharmaceutical manufacturing and process control.
Article
Public, Environmental & Occupational Health
Sonia Gandhi, Smita Kashiramka, Anurag S. Rathore
Summary: The high prices of biotherapeutics are a concern for agencies working on strategies to manage medicine prices and promote equitable access. This study identifies factors influencing the price of biotherapeutics, highlighting the importance of considering innovation capability, development costs, and regulatory environment. Policymakers need to implement innovative pricing frameworks that align with national policies, regulations, and market dynamics.
WORLD MEDICAL & HEALTH POLICY
(2023)
Article
Biotechnology & Applied Microbiology
Anupa Anupa, Vikrant Bansode, Nikhil Kateja, Anurag S. Rathore
Summary: This article presents a novel approach for the separation of charge variants during continuous CEX chromatography. By combining displacement mode chromatography and salt-based step elution, the content of acidic and basic variants is effectively controlled. Compared to traditional methods, this approach increases resin productivity and utilization, while achieving high recovery rates.
BIOTECHNOLOGY PROGRESS
(2023)
