Industry Insights
-
3 Action Items For The US Bio/Pharma Industry To Mitigate Supply Vulnerabilities
6/12/2023
The United States’ reliance on foreign manufacturers of API has been a known fact for several years. We can mitigate our supply vulnerabilities, but bio/pharma companies and the FDA both have roles to fill in this need.
-
ULD Air Cargo Containers - Quality versus Redundancy – Where’s the Argument?
6/16/2015
In the engineering and manufacturing process, we think of a system failure backup as ‘redundant’. However, in many cases, the development, installation and use of redundant systems can backfire and produce less, not more, reliability.
-
Optimizing Digitalization To Accelerate Your R&D
5/19/2023
Drug/therapy development has made significant leaps in innovation in recent years, but common issues that hinder progress still exist. Are you harnessing and optimizing your data for speedier drug development and quicker launch timescales? This article shares important recommendations.
-
4 Steps To “Right Sizing” Your Personnel Resources To Support Quality
We all have them and we all need them. The real question is do you have the right resources? And, do you have enough to support your quality system? By Christine Park, Quality Architech
-
6 PEG Alternatives You Should Be Thinking About
11/22/2023
PEGylation is a common way to minimize off-target effects and general toxicity, but it also poses life-threatening risks because it prolongs the drug's time in the bloodstream. Scientists are exploring these alternatives to combat the risk.
-
Best Practices For Data Integrity Oversight At Your Contract Manufacturer
12/4/2017
Part 1 of this two-part article addressed FDA warning letter enforcement actions and discussed things that can go awry in these relationships related to data governance and data integrity. In Part 2, we turn our attention to health authority GMP guidance on contractual relationships and best practices that should be considered in this area.
-
Save Time And Money On Turn-Over Packages, Pre-Validation, And Factory Acceptance Testing
1/14/2013
Documentation developed, information collected, and labor expended to create a turn-over package (TOP) for a biopharm modular system represents a significant cost to any project. So much so, that when working with a client, we jokingly say “we sell documentation and you get the system for free.” To properly validate a system, you have to make the investment in documentation, but you can realize significant labor and cost advantages when developing TOP documentation and pre-validating your modular system via Factory Acceptance Testing in a closed-shop environment. By Mark McGlynn, President, IPEC
-
Selecting The Right CDMO Partner – Three Keys To Success
10/25/2019
With various competing CDMOs available, selecting the right partner for your business can be difficult. Here are the three key areas to consider when selecting your drug product manufacturing partner.
-
Integrating Risk Management Into Your QMS — An Essential Toolkit
6/11/2018
Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system is the integration of risk-based thinking. Risk-based thinking can and should be applied to the organization’s strategic and tactical planning processes.
-
Developing And Manufacturing Cell & Gene Therapies: Do Biopharma Methods Apply?
9/3/2019
Are the methods used for developing the current generation of biopharmaceuticals, monoclonal antibodies, hormone replacements, etc., applicable to the next generation of Cellular and gene therapies?