Read, Learn, Innovate: Top Blog Posts from May 2020
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from May 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
Supporting Pharma Innovation Through Analytics
Ensuring delivery of effective medicines requires an agile business strategy effectively utilizing technology to:
- shorten process development times from lab to commercial launch
- establish streamlined facilities with emphasis on sustainability and flexibility
- achieve robust quality through utilization of control and predictive capabilities
- ensure a well-defined process operational space
Why is Data Integrity an Essential Part of the Pharma Industry?
In recent years significant problems with data integrity have been found in the pharmaceutical, biotechnology, and medical device industries worldwide. This ultimately affects patients, as patient safety is intrinsically impacted by the integrity and quality of the data on which a regulatory decision is based.
How to Comply with Regulations & Guidance for Water & Steam Systems
The design, construction, commissioning, qualification, and continued performance of water and steam systems for the pharmaceutical industry present significant challenges. These systems need to meet Good Manufacturing Practice (GMP) regulations while remaining in compliance with all other governing codes, laws, mandates, and regulations.
Future of Continuous Manufacturing: Large and Small Molecule
Major companies were working aggressively to develop and bring to market an ever-expanding set of candidates, and of modalities, to the benefit of patients. Large suppliers innovating manufacturing technologies and analytical approaches needed to help accelerate development timelines and allow for increased flexibility in manufacturing paradigms.
The Future of Novel Emerging Manufacturing Technologies
The spectrum of gene therapy with some specificity to viral vectors is very broad including both delivery vehicles developed for transient short-term and permanent long-term expression. Moreover, the types of vectors are represented by both RNA and DNA viruses with either single-stranded (ss) or double-stranded (ds) genomes. The approval and or under regulatory review of viral vector-based drugs are making progress in the cure and or treatment of certain ailments.
