ARTICLES BY JERRY MARTIN

• Pulling Double Duty: Packaging Considerations For Combination Products

  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.

• Aggregation 101: Connecting The Dots Between Pharma Serialization And Track-And-Trace

  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.

• Applications For Single-Use Systems In Biosimilar Development

  Exploring the benefits, challenges, and future of disposable systems in biosimilar manufacturing.

• Is Continuous Manufacturing Right For Your Drug?

  Adapting any manufacturing process to continuous manufacturing requires in-depth chemical and mechanical engineering understanding as well as the right technologies.

• Big Data And AI In Pharma Development And Manufacturing: An Inside Look

  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.

• Single-Use Systems: The Benefits, The Challenges, And Selection Criteria

  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.

• New Regulations And Safety Complicate Drug Labeling

  Multinational pharmaceutical companies have for decades manufactured drugs for global distribution. Nevertheless, the task of labeling is becoming increasingly difficult and time-consuming. 

• An Introduction To Biopharma Facility Commissioning & Qualification

  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.

• Modular Facility Design & Single-Use Equipment Considerations For Pharma

  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. 

• Serialization In Practice: How Manufacturers Can Ensure Compliance

  Pharmaceutical manufacturers cannot limit responsibility for DSCSA compliance to just the engineers and operators involved in processing and packaging.