Read, Learn, Innovate: Pharmaceutical Engineering® Holiday Reading Edition
Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are some great reading selections for the holidays! This year’s holiday topic: biopharma, cell and gene therapies, and ATMPs. That topic is the theme for the November-December 2021 issue , and here are some earlier articles on these important and timely topics.
Current State of Oligonucleotide Therapeutics
Oligonucleotides are a relatively new class of drugs, composed of natural and synthetic nucleotides, which primarily include small interfering RNA (siRNA), micro RNA (miRNA), and antisense oligonucleotide (ASO). These molecules achieve therapeutic effects through RNA interference, degradation, or splice-modulating pathways. Other oligonucleotide therapies include messenger RNA (mRNA, single strand, >500 mers), small activation RNA (double strand, ~20 mers), antagomir (single strand, ~20 mers), and aptamer (single strand, >30 mers). This article focuses on synthetic ASOs (single strand, 16–22 mers) and siRNAs (double strands formed by hybridization of a pair of complementary sense and antisense strands, 19–25 mers).
Biopharma Facility Design: Lessons Learned on the Dance Floor
In 2014, Pharmaceutical Engineering published an article, “Lessons Learned in the Ballroom,” which presented for the first time an alternative to the then-popular ballroom concept adopted by biopharmaceutical manufacturers for drug substance facilities. Now, six years later, we revisit that article to look back at what has happened in biopharma factory design since 2014 and look forward to ever-evolving practices in single-use and hybrid facilities.
Cell and Gene Therapies & Their GMP Requirements
Cell and gene therapies are the latest revolution in medicine manufacturing. Unlike small molecules or traditional biotech products, these therapies introduce cells and genes into a patient to treat the underlying cause of a disease—they are living medicines. This article provides an overview of key considerations for manufacturers of cell and gene therapies. It is primarily relevant to manufacturing in the UK and Europe, but has leveraged worldwide references where possible.
Biopharma Growth Trends: More Innovation on the Way
Innovation has been and continues to be a driver for the strides being made in biopharma development and manufacturing, noted Eric S. Langer, President and Managing Partner, BioPlan Associates, Inc., who addressed “Innovation in Transformative Medicine: What’s Changing the Bioprocessing Landscape.” He shared some results of research conducted by his company on biomanufacturing growth trends.
