Cover: Many organizations are evaluating how advanced therapy medicinal products (ATMPs) and other traditional modalities may be combined within the same facility or within a newly constructed agnostic building. This article outlines a broad framework to evaluate di erent types of modalities that may be accommodated concurrently in a new or existing facility and then uses a case study to explain how the approach may be applied to an existing facility.
Feature: Cell and gene therapies (C>) have unique needs in manufacturing suites that differ from those for classic product biopharmaceuticals. Facilities must be created with flexibility in mind, able to run multiple products and production types to remain viable.
Feature: Resounding clinical successes and maturation of extensive therapeutic pipelines have catapulted oligonucleotides from a fringe modality to therapeutic relevance in just a few short years. Oligonucleotides are a cornerstone of a burgeoning class of drugs classified as nucleic acid therapeutics. These therapies interact with DNA and RNA targets rather than traditional protein therapeutic targets. Oligo therapies offer access to gene regulation mechanisms that were previously inaccessible for treatment. Oligos are also a key component of gene editing systems, serving as the guiding instructions for DNA and RNA editing technologies.
TECHNICAL: This artificial intelligence (AI) retrofit project was a unique approach to implementing AI technology in a pharmaceutical environment within three months. This project tackles a commonly known industry challenge by integrating AI into an existing automatic visual inspection (AVI) machine. The proof of value allowed us to benchmark added value through AI compared with state-of-the-art automated visual inspection.
TECHNICAL: Before the COVID-19 pandemic, it was unthinkable for a system integrator to suggest remotely conducting an acceptance test for an automation project. This article shows how automation engineers and client validation personnel were successful in navigating COVID-19 restrictions and overcoming previously held preconceptions about remote testing to meet end-user and regulatory requirements. Although there were some advantages, both testers and reviewers found the experience inefficient and unsatisfactory in terms of rapport and visibility.