Article
Chemistry, Analytical
Silvia Millan-Martin, Craig Jakes, Sara Carillo, Jonathan Bones
Summary: Adalimumab, the first fully human monoclonal antibody approved by FDA, is the most profitable drug in the world. The expiration of patent protection opens up the market for adalimumab biosimilars, which have the potential to lower costs and increase patient accessibility. This study uses a multi-attribute method to analyze the similarity of different adalimumab biosimilars.
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
(2023)
Article
Biochemistry & Molecular Biology
Anurag S. Rathore, Srishti Joshi, Neh Nupur, Nikita Saxena, Sanghati Bhattacharya, Souhardya Roy
Summary: Biosimilar manufacturers use a chemometric approach to assess biosimilarity, aiming to simplify assessment and eliminate individual bias. This approach collates chemical information into a single plot for quantitative assessment. It allows for numerical grading of similarity for biosimilars and can be easily incorporated within the existing regulatory framework.
INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES
(2023)
Article
Engineering, Industrial
James Dockree, Qian Wang, Regina Frei
Summary: The aim of manufacturing quality control is to ensure defect-free products without unnecessarily increasing time and cost. Over-control or under-control can be detrimental to manufacturers. Operators often rely on personal knowhow due to lack of scientific guidance. Error Chain Analysis (ECA) is introduced as a new method to improve quality control effectiveness in multi-stage manufacturing processes.
PRODUCTION PLANNING & CONTROL
(2021)
Article
Engineering, Biomedical
Umberto M. Musazzi, Silvia Franze, Fabrizio Condorelli, Paola Minghetti, Paolo Caliceti
Summary: New and innovative nanomedicines have revolutionized the prognosis of many human diseases. However, their peculiar physicochemical properties pose new challenges in regulatory approval. This article critically discusses the current open issues regarding regulatory qualification and physicochemical characterization of nanosystems, considering the current European regulatory framework on nanomedicine products. Practicable paths for improving their quality assurance and predicting their fate in vivo are also proposed.
ADVANCED HEALTHCARE MATERIALS
(2023)
Article
Engineering, Chemical
Zhenhua Gao, Fuqiang Xu, Chunliu Zhou, Hongliang Zhang
Summary: A method combining genetic back-propagation neural network algorithm and grey relational analysis is proposed to control the quality and identify the critical procedures in the product manufacturing process. By applying this method to the manufacturing process of the evaporator, four critical procedures have been successfully identified.
Review
Pharmacology & Pharmacy
Deeksha Joshi, Rubiya Khursheed, Saurabh Gupta, Diksha Wadhwa, Thakur Gurjeet Singh, Sumit Sharma, Sejal Porwal, Swati Gauniyal, Sukriti Vishwas, Sanjay Goyal, Gaurav Gupta, Rajaraman D. Eri, Kylie A. Williams, Kamal Dua, Sachin Kumar Singh
Summary: Biologic-based medicines, including biosimilars, have the potential to enhance cancer treatment by providing lower-cost options and increasing accessibility. However, there are challenges such as cost, immunogenicity, lack of awareness, extrapolation of indications, and interchangeability.
Review
Biotechnology & Applied Microbiology
Neh Nupur, Srishti Joshi, Davy Gulliarme, Anurag S. Rathore
Summary: Biopharmaceuticals, especially biosimilars, are experiencing rapid growth in the biotechnology industry. The key to successful biosimilar approval lies in establishing analytical and clinical biosimilarity with the innovator. This review provides a comprehensive view of the progress in biosimilar analysis and approval, including global regulatory developments, catalogued biosimilarity assessment studies, and advancements in analytical methods since 2015.
FRONTIERS IN BIOENGINEERING AND BIOTECHNOLOGY
(2022)
Article
Engineering, Industrial
Salah Haridy, Udechukwu Ojiako, Ahmed Maged, Mezoon Al Remeithi, Hamdi Bashir, Mohammad Shamsuzzaman
Summary: Statistical Process Control (SPC) is used to support the quality performance of production and manufacturing processes. Control charts, such as Exponentially Weighted Moving Average (EWMA), are widely used to reduce variation, improve productivity, and ensure quality. However, small manufacturers face challenges, particularly resource constraints, that hinder their effective use of control charts. This study presents an improved EWMA control chart that considers significant resource constraints in a small aluminium manufacturing firm, and its adoption can enhance defect detection without requiring additional resources.
PRODUCTION PLANNING & CONTROL
(2023)
Article
Pharmacology & Pharmacy
Lise Vandevivere, Maxine Vangampelaere, Christoph Portier, Cedrine de Backere, Olaf Hausler, Thomas De Beer, Chris Vervaet, Valerie Vanhoorne
Summary: The selection of pharmaceutical binders for twin-screw wet granulation should be based on a scientific approach to enable efficient formulation development. Binder effectiveness in the wet granulation process is influenced by binder attributes, which vary depending on the solubility of the formulation. Identifying critical binder attributes is essential for rational and efficient binder selection in both well soluble and poorly soluble formulations.
Review
Chemistry, Analytical
Ratih Ratih, Mufarreh Asmari, Ahmed M. Abdel-Megied, Fawzy Elbarbry, Sami El Deeb
Summary: Biologics have complex production processes and face various challenges, including similarity testing and international regulatory guidelines. Since 2006, biosimilars have entered the biotechnology arena with intense competition.
MICROCHEMICAL JOURNAL
(2021)
Article
Computer Science, Interdisciplinary Applications
Barry R. Cobb
Summary: This paper introduces an intermittent sampling model for statistical process control (SPC) in order to monitor the quality of output from a production process. The model determines the time periods for collecting samples and the decision strategy to minimize quality control costs. It offers a simpler and more efficient approach compared to Bayesian methods by only requiring the result of the current sample for decision-making.
COMPUTERS & OPERATIONS RESEARCH
(2024)
Article
Computer Science, Interdisciplinary Applications
Roberto C. Quinino, Frederico R. B. Cruz, Victor B. Quinino
Summary: The paper introduces a new control chart, XkA, for evaluating the stability of a process mean. By combining attribute and variable inspections, the XkA chart demonstrates lower average cost compared to traditional methods, while maintaining similar average run length values and inspection costs. A numerical application is presented to showcase the applicability of the proposed control chart.
COMPUTERS & INDUSTRIAL ENGINEERING
(2021)
Article
Oncology
Nadine Kirsch-Stefan, Elena Guillen, Niklas Ekman, Sean Barry, Verena Knippel, Sheila Killalea, Martina Weise, Elena Wolff-Holz
Summary: The study found that in 67% of cases, the outcomes of quality and clinical assessments aligned, either supporting or not supporting approval. Major objections were identified in the quality part in 11% of cases, while 22% of cases had major objections raised in the clinical data package. However, no negative overall decisions were solely based on seemingly negative clinical data, suggesting that clinical trials were not essential in resolving uncertainties related to quality in biosimilar evaluations.
Article
Multidisciplinary Sciences
Hye-Na Kang, Robin Thorpe, Ivana Knezevic, Mary Casas Levano, Mumbi Bernice Chilufya, Parichard Chirachanakul, Hui Ming Chua, Dina Dalili, Freddie Foo, Kai Gao, Suna Habahbeh, Hugo Hamel, Gi Hyun Kim, Violeta Perez Rodriguez, Desi Eka Putri, Jacqueline Rodgers, Maria Savkina, Oleh Semeniuk, Shraddha Srivastava, Joao Tavares Neto, Meenu Wadhwa, Teruhide Yamaguchi
Summary: The World Health Organization has issued guidelines for regulatory evaluation of biosimilars, but a recent survey revealed challenges including lack of reference products, resources, and quality issues with some biosimilars. Solutions include information exchange, reliance concept adoption, reassessment of approved products, and establishing appropriate regulatory oversight for good pharmacovigilance.
ANNALS OF THE NEW YORK ACADEMY OF SCIENCES
(2021)
Article
Biochemical Research Methods
Xiaoyan Guan, Tamer Eris, Le Zhang, Da Ren, Margaret S. Ricci, Tiffany Thiel, Chetan T. Goudar
Summary: During the manufacturing of therapeutic proteins, conventional methods may generate individual peaks that contain multiple components, causing difficulties in detection and quantification of critical quality attributes (CQAs). The Multi-Attribute Method (MAM) enables more accurate detection and quantification of specific CQAs and provides operational flexibility.
ANALYTICAL BIOCHEMISTRY
(2022)