Industry Insights
-
Spark’s Luxturna Gene Therapy: What Can We Learn From Its Development & Commercialization?
4/10/2018
Part 2 of this two-part article reviews lessons from Spark Therapeutics’ pivotal program for Luxturna, a gene therapy approved for the treatment of patients with retinal dystrophy associated with confirmed biallelic mutation in the RPE65 gene, and summarize key considerations for the clinical development and commercialization of gene therapies.
-
Applying Lean Thinking To Support Processes in MedTech, Biotech Organizations
10/9/2019
This article answers the question, “how can lean thinking be applied to areas like QARs, QC tests, and document control procedures to remove waste while still adhering to regulations?”
-
Overcoming Cell Line Development Challenges With Early-Stage Processes
The biopharmaceutical industry is trending toward building process characterization systems and processes early in a project’s life cycle, enabling success for later-stage development.
-
4 Keys To Bridging The Biosimilar Gap: Transforming Awareness Into Prescribing Action
1/30/2018
History tells us changes in physician attitudes don’t always correlate to a change in behavior at the point of care. And biosimilars also need to overcome clinical hurdles to provider acceptance.
-
Applying Industry Benchmarks To Dictate Your CDMO Choice
2/23/2023
Commonly utilized as a market research tool, learn how performance benchmarking is helping to make CDMO selection less arduous.
-
Starting A Career In Clinical Research: 7 Things We Wish We Knew
11/24/2020
The clinical research industry is facing a talent shortage that could become acute in the next decade. A main contributor to this shortage is a lack of focused intervention at every level to identify the skills, behaviors, and knowledge that will enable motivated candidates to begin and mature their careers in the industry.
-
Continuous Manufacturing: Many Want It, But Here’s Why Few Have It
2/13/2024
In 2023, biomanufacturers showed an increasing interest in continuous manufacturing, but uptake, believe it or not, slowed down. Let’s explore the reasons why with data from BioPlan Associates.
-
Calculating Process Capability Of Cleaning Processes With Completely Censored Data
10/31/2022
Data below the detection limit (DL) are known as left-censored data. Quite often, 100% of the results of the cleaning samples fall below the DL. How can cleaning process capability be calculated in such situations? This article explores several approaches.
-
Agile Software Development In Bio/Pharma & Medical Devices, Part 3
7/25/2023
Computer software/systems validation testing are used to validate software under GxP environments. Parts 1 and 2 of this article series shared Agile methodology with regard to the phases of planning, team structure and collaboration, software architecture, and more. In this final installment, the author discusses software release, configuration and change management, CAPA, and more.
-
How Should I Respond To This FDA Warning Letter? (And Other Compliance Questions Answered)
9/25/2017
Success in developing a drug product, medical device, or drug substance requires navigating the tradeoffs and decisions of today's complex global regulatory realm. Some of the most common questions about compliance concern dealing with the FDA 483 list of inspection observations, warning letters, and consent decrees following FDA regulatory action.