LEARNING – MES Engineer

Why Chinese Hamster Ovaries are used in the pharmaceutical industry?

August 25, 2023August 25, 2023 MES ENGINEER

Chinese hamster ovary (CHO) cells are commonly used in the pharmaceutical industry for the production of therapeutic proteins. There are several reasons for this: It is important to note that while CHO cells are widely used, other cell lines such as human embryonic kidney (HEK) cells and insect cells (baculovirus expression system) are also utilized in the pharmaceutical industry for protein production. The choice of cell line depends on factors such as the nature of the protein being produced, production requirements, and regulatory considerations.

Upstream vs Downstream – Pharmaceutical Manufacturing Explained

August 25, 2023August 25, 2023 MES ENGINEER

Upstream and downstream are terms used in pharmaceutical manufacturing to describe different stages of the production process. Upstream refers to the initial stages of manufacturing, which involve the cultivation and growth of cells or organisms that produce the desired drug or therapeutic substance. This can include activities such as cell line development, fermentation, and primary purification. Downstream refers to the subsequent stages of manufacturing, which involve the purification, separation, and processing of the drug substance obtained from upstream processes. Downstream activities typically include filtration, chromatography, crystallization, and formulation. In summary,…

Using IIoT and AI in Manufacturing

August 25, 2023August 25, 2023 MES ENGINEER

IIoT (Industrial Internet of Things) refers to the network of interconnected devices, sensors, and machines in industrial settings. It enables the collection, analysis, and sharing of data to improve efficiency, productivity, and decision-making. AI (Artificial Intelligence) can be integrated with IIoT to enhance manufacturing processes in several ways: In summary, the combination of IIoT and AI in manufacturing allows for improved predictive maintenance, enhanced quality control, optimized production, intelligent automation, and product innovation. This integration can drive operational excellence, cost savings, and competitive advantages in the manufacturing industry. OPEN Source…

ISA-95 Explained

August 20, 2023 MES ENGINEER

ISA-95, also known as the International Society of Automation standard, is a comprehensive framework that provides guidelines for integrating different systems and processes within the manufacturing industry. The standard focuses on improving communication, data exchange, and interoperability between various levels of an organization, such as the control level, operations level, and business level. The ISA-95 standard is divided into a hierarchical model that consists of four levels: ISA-95 provides a common language and set of guidelines for data exchange and integration between these levels. It enables manufacturers to integrate different…

Basics of setting up a F5 Load Balancer

August 20, 2023 MES ENGINEER

To set up an F5 load balancer with health monitoring, port-based load balancing, and session persistence, you can follow these steps: Please make sure to consult the official F5 documentation for detailed instructions specific to your F5 load balancer model and firmware version.

ALCOA+

August 20, 2023 MES ENGINEER

ALCOA+ is a quality management framework used in various industries, particularly in healthcare and clinical research. It is an extension of the original ALCOA principles, which are a set of guidelines to ensure data integrity in regulated environments. ALCOA stands for: The “+” in ALCOA+ represents additional principles that enhance data integrity. These principles include: Adhering to the ALCOA+ framework helps organizations ensure the reliability and trustworthiness of their data by maintaining accurate, complete, and unalterable records. By following these principles, organizations can improve data quality, transparency, and compliance with…

Common Biotech Buzzwords and Descriptions

August 20, 2023 MES ENGINEER

Buzzword Description Gene Editing The process of modifying an organism’s genetic material to achieve desired traits or characteristics. It involves targeted changes to the DNA sequence, such as adding, deleting, or modifying specific genes. CRISPR A revolutionary gene-editing technology that allows scientists to precisely modify an organism’s DNA. CRISPR-Cas9, the most widely used CRISPR system, uses a molecular tool to guide the editing process by directing the Cas9 enzyme to cut the DNA at specific locations, enabling the addition, removal, or modification of genetic material. Biopharmaceuticals Medicinal products derived from…

The Purdue Model of Security for Manufacturing: Safeguarding Industrial Control Systems

August 20, 2023 MES ENGINEER

In an increasingly interconnected world, securing industrial control systems (ICS) has become a critical concern for manufacturing companies. One widely recognized approach to ICS security is the Purdue Model, also known as the Purdue Enterprise Reference Architecture. Developed by the Purdue University’s Center for Education and Research in Information Assurance and Security (CERIAS), this model provides a framework for organizing and securing control systems in manufacturing environments. Understanding the Purdue Model The Purdue Model is based on the concept of hierarchical levels, each responsible for specific functions and security controls…

Understanding the Significance of 21 CFR Part 11 in GMP Compliance

August 20, 2023August 20, 2023 MES ENGINEER

Introduction In the highly regulated world of pharmaceuticals, biotechnology, and medical device manufacturing, ensuring product quality, safety, and data integrity is of utmost importance. One crucial regulation that governs electronic records and signatures is 21 CFR Part 11. This article aims to shed light on the significance of 21 CFR Part 11 in Good Manufacturing Practices (GMP) compliance. What is 21 CFR Part 11? 21 CFR Part 11, also known as Part 11, was established by the U.S. Food and Drug Administration (FDA) in 1997. It outlines the requirements for…

MES 4.0 Explained

August 20, 2023November 24, 2023 MES ENGINEER

MES 4.0: Revolutionizing Manufacturing Operations In the era of Industry 4.0, Manufacturing Execution Systems (MES) have taken on a new form: MES 4.0. This technology-driven solution has the potential to revolutionize manufacturing operations, bringing unprecedented levels of efficiency, visibility, and flexibility to the shop floor. What is MES 4.0? MES 4.0 refers to the integration of traditional MES with the advancements of Industry 4.0 technologies such as artificial intelligence (AI), Internet of Things (IoT), cloud computing, and big data analytics. It extends beyond the traditional boundaries of the shop floor,…