ARTICLES BY JERRY MARTIN
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Pulling Double Duty: Packaging Considerations For Combination Products1/2/2020
Blending formula and function into one neatly packaged item may seem to simplify the drug delivery process for end users, be they healthcare professionals or patients, but a product that pulls double duty comes with its own set of challenges. Combination products require their own precautions and packaging measures that help to ensure quality, safety, and reliability.
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Aggregation 101: Connecting The Dots Between Pharma Serialization And Track-And-Trace8/19/2019
From “serialization” to “coding” to “track-and-trace,” the pharmaceutical industry is rampant with terms that point to the quest for transparency. The latest of these is “aggregation,” a burgeoning method of data collection aimed at simplifying inventory and the supply chain. While still in its infancy, the technique can help to combat counterfeiting, theft, inefficiencies, and confusion as a whole. Yet, with every new process comes challenges, requiring manufacturers considering aggregation to seek best practices for implementation.
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Applications For Single-Use Systems In Biosimilar Development7/16/2019
Exploring the benefits, challenges, and future of disposable systems in biosimilar manufacturing.
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Is Continuous Manufacturing Right For Your Drug Product?5/30/2019
Adapting any manufacturing process to continuous manufacturing requires in-depth chemical and mechanical engineering understanding as well as the right technologies.
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Big Data And AI In Pharmaceutical Development & Manufacturing — An Inside Look2/27/2019
Artificial intelligence and Big Data have the potential to lower the cost and time of drug trials, to better determine patient outcomes with established drugs, and to better design new drugs.
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3D Printing In The Pharmaceutical Industry — Where Does It Currently Stand?12/21/2018
In 2015, Aprecia Pharmaceuticals produced the first tablet manufactured through 3D printing to be approved by the FDA. Now, with applications in controlled release, short-run medicines, and even the potential for on-site printing at pharmacies, 3D printing technology has the ability to transform the pharmaceutical industry.
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Single-Use Systems: The Benefits, The Challenges, And Selection Considerations9/24/2018
The drive to reduce costs, increase speed to market, and meet regulatory requirements has led many pharmaceutical companies to look at single-use, pre-sterilized, plastic equipment systems as an alternative to stainless steel lines. Despite all the benefits — cost, efficiency, etc. — there are still challenges to implementing single-use systems.
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New Regulations And Safety Complicate Drug Labeling7/2/2018
Multinational pharmaceutical companies have for decades manufactured drugs for global distribution. Nevertheless, the task of labeling is becoming increasingly difficult and time-consuming.
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An Introduction To Pharmaceutical Facility Commissioning & Qualification4/20/2018
When looking at facility commissioning and qualification, it's often good to start out with understanding key words so that everybody's on the same page.
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Modular Facility Design & Single-Use Equipment Considerations For Pharma Manufacturing1/26/2018
With the development of structural, component, or subsystem pieces that are standardized and able to be assembled in virtually limitless ways, pharmaceutical companies can quickly and easily set up their manufacturing facilities.
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Serialization In Practice: How Manufacturers Can Ensure Compliance10/2/2017
Pharmaceutical manufacturers cannot limit responsibility for DSCSA compliance to just the engineers and operators involved in processing and packaging.
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State Of Serialization: Where FDA & The Pharma Industry Currently Stand9/1/2017
For the Drug Supply Chain Security Act to be effective, it requires pharma to institute electronic, interoperable systems that enable stakeholders to identify and trace drugs distributed into the U.S.
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What Role Should Your Suppliers Play In Single-Use Equipment Validation?6/5/2017
In the ongoing battle to cut costs while delivering quality and technically sound product, the biotech industry has spent the past two decades gradually moving toward single-use pre-sterilized plastic equipment for both clinical batch and, where applicable, production scale manufacturing.
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4 Major Trends In Pharmaceutical Packaging1/13/2017
There are few better places to learn more about the state of an industry than a trade show. This past November’s Pharma EXPO, co-located with PACK EXPO International 2016 at Chicago’s McCormick Place, offered a firsthand look at some of the changes and new trends that are shaping the drug industry — including new serialization technologies and inspection technologies. Additionally, new processing equipment is being developed to handle the novel biological formulations and personalized medicines that are becoming more prevalent in today’s market. This article will discuss some of the important industry trends I observed on the show floor.
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Taking the Long Road to Continuous Manufacturing6/8/2016
New manufacturing methods that cut processing steps, speed production, improve efficiency and increase quality and safety all sound like great ideas.