Industry Insights
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Driving Continuous Improvement With A Fully Integrated Quality System
A well-designed quality system has a global scope, incorporating guidelines from all relevant markets and assuring data quality and integrity through adherence to quality standards, policies, and procedures.
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Should You List All Manufacturing Facilities In Your Drug Application? A Question Of Regulatory Ethics
5/15/2020
In this second installment of a two-part article, we will review the importance of listing all appropriate manufacturing facilities in the drug substance section of a drug application and discuss the role of regulatory professionals in ensuring that the necessary information is included in the application.
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An Independent Expert’s Guide To Picking Nanoparticle Manufacturing Equipment
7/26/2023
Until recently, nanoparticle manufacturers had to change equipment between preclinical, clinical, and commercial phases. Advances in technology offer more flexibility allowing manufacturers to turn up the dial on the same machines — from early development all the way to commercialization.
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Overcome Complex Protein Challenges With Optimized Expression
Realizing the potential of next-generation molecules calls on appropriate expression technologies and development processes that can facilitate their path to market.
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Second Chances: Repurposing Drugs For Type 2 Diabetes
3/28/2014
Look around. Think differently. What’s old may be new again. By Erik Rocheford, study director in Discovery Research Services, Charles River
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An Introduction To Forced Degradation Studies For Drug Substance & Drug Product
1/9/2020
The forced degradation study is a vital analytical aspect of the drug development program for small molecules. Commonly known as stress testing, it is carried out to demonstrate as specificity to developed a stability-indicating analytical method, using high-performance liquid chromatography (HPLC). As per ICH Q1A, stability studies must be performed to propose the shelf life of new drug substances and/or drug products.
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Human Performance Theories And SOPs: Human Error Prevention In Manufacturing
11/3/2023
Standard operating procedures (SOPs) are often viewed as mere documents to be followed, rather than as dynamic tools. Drawing on human performance theories, this article explores how to create, review, and train on SOPs, as well as how manufacturing and quality teams can collaborate to improve oversight, all with human error prevention in mind.
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Taking (Better) Control Of Your Outsourced Analytical Activities
6/8/2017
When a sponsor signs a contract with a CDMO, the analytical chemistry to-do list may look like the easiest part of the agreement. However, it can be the most challenging to manage in a total outsourcing model of drug development.
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The One Trait A Medtech QA/RA Professional Can’t Succeed Without
5/14/2021
We read studies showing that professionals who are successful and hold top positions in our industry possess certain traits: intelligence, commitment to our jobs, determination, etc. But those traits could describe many professionals. So, what is it that makes us unique and a good fit for this industry?
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A Bridge Over Troubled Water: The Journey To Serialization Compliance
This regulation from the FDA outlined serialization and traceability requirements spread over the course of 10 years with preparation for each phase accumulating into a potentially high overall price tag.