Information Technology

Protecting Artificial Intelligence Inventions in Drug Development

Artificial intelligence (AI) is a lot more sophisticated today than it was just a few years ago. Its impacts are felt outside of technology applications such as computing, malware, and natural language processing. For example, Google’s AI (called DeepMind) recently solved one of biology’s greatest problems: It determined a protein’s three-dimensional shape from its amino acid sequence. Now, AI is making a foray into drug development processes. Drug development is a risky, expensive, time-consuming, yet often lucrative venture. The costs…

Working with Big Data in Healthcare and Bioprocessing Settings: A Brief Introduction to Key Components and Considerations

Artificial intelligence (AI) in healthcare and biopharmaceutical industries still is in early stages of development and use, yet proper data management is critical to successful implementation at any stage of the enterprise continuum. AI is applied to help researchers understand and analyze biology, diagnose diseases, design new drugs, and predict clinical potential and treatment outcomes. AI has been applied in the discovery and development of novel drugs and for repurposing existing drugs, manufacturing different types of drug products, and optimizing…

Pathogen Safety Digital Platform for Biopharmaceuticals: The Journey from Ground to Cloud

Digital transformation is at the heart of many biopharmaceutical companies’ strategies for ongoing success. However, the definition of digital transformation and what it consists of differ within the bioprocess industry (and might even vary within a single company), specifically as it applies to the overall value chain from R&D to clinical trials, manufacturing, supply chain, and eventually commercial operations. To provide a perspective on what digital transformation could look like in bioprocessing, we present a case study about an exploratory…

Realization of Quality By Design and Beyond: The Intelligent Cell Processing System

Cells are used as raw materials, intermediates, and final products in biopharmaceutical and cell therapy manufacturing. Because living cells are always in a dynamic state, their characteristics must be kept within specified ranges throughout bioprocessing to preserve their utility. Cell population expansion without changing the original cell properties is key for obtaining the required number of cells at the next step. However, limited process data are collected during the expansion phase — information that could be used to understand and…

Designing Vaccines: The Role of Artificial Intelligence and Digital Health, Part 2

In BPI’s October 2021 issue, part one of this review introduced the concepts of machine learning (ML) and artificial intelligence (AI), identifying some broad areas of application within vaccine discovery, preclinical testing, and clinical studies. This month, we conclude with a detailed discussion of specific disease targets and AI’s potential in addressing them. Having highlighted the example of Zika virus in part one, below we focus on malaria, tuberculosis, human immunodeficiency virus (HIV), herpesvirus, hepatitis, and pandemic coronavirus. Malaria Malaria…

eBook: Cell and Gene Therapies — Optimization Strategies for Processing and Potency

Although relatively new to the biopharmaceutical industry, cell and gene therapy development and manufacturing are advancing rapidly. At Informa Connect’s September 2021 Cell & Gene Manufacturing & Commercialization Conference and Exhibition, held in Boston and online, presentations reviewed concerns that arise when processing complex therapies and highlighted some innovative strategies for surmounting those obstacles. Most of those approaches described during the event used data-driven solutions, with each step building on the information gained from the previous one. High-throughput technology platforms…

Designing Vaccines: The Role of Artificial Intelligence and Digital Health, Part 1

According to the founder and executive chairman of the World Economic Forum, Klaus Schwab, the fourth industrial revolution began in the 21st century and is characterized by an unprecedented development and exponential growth of a high-technology industry transforming society at every level (1–4). In particular, healthcare systems are evolving rapidly to adapt to the new reality. According to Forbes, the main technologies currently shifting the paradigm of medical research are artificial intelligence (AI) and machine learning (ML) (5), both defined…

Multivariate Data-Driven Modeling for Continued Process Verification

Continued process verification (CPV) is an integral part of process validation for the manufacture of human and animal drugs and biological products (1). It is designed to meet three primary goals: maintain a validated state of products, their processes, and related systems; enable continuous process improvements; and meet regulatory requirements for life-cycle validation. A CPV program for a biologic product entails regular collection of data related to critical process parameters (CPPs) and critical quality attributes (CQAs) and the preprocessing, analysis,…

Simplifying the Bioprocessing 4.0 Journey

Bioprocessing 4.0, the biopharmaceutical version of Industry 4.0, is on course to become a reality in the next decade (1). This is because its “cyber-physical systems” that comprise cloud computing, connected systems, and digital process control offer many benefits. They include better process monitoring and management of a biologic’s critical quality attributes (CQAs) and the chance to control intensified processes for faster, less-expensive production of protein-based biologics and vaccines. Automation also can reduce the number of skilled operators needed while…

Prepared for the Future?
Smart Maintenance Is Key to Industry 4.0

With the rapid advancement of digitalization, new technologies and flexible production concepts have become essential parts of the biopharmaceutical industry, especially for implementing Industry 4.0, the Internet of things (IoT), and predictive maintenance. As an expert partner for digitalization, Zeta supports its customers with new tools for smart maintenance. Swift commissioning helps biomanufacturers complete their projects successfully. That requires trained personnel and maintenance support. Intelligent tools based on digital plant data ensure smooth operation. Smart Maintenance Navigator (SMN) technology is…