ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• FAQs On The Revised EU GMP Annex 1: Volume 6

  The revised EU GMP Annex 1 prioritizes a CCS. Learn how to holistically manage microbial, particulate, chemical, and cross-contamination risks to ensure product sterility and patient safety.

• What To Consider When Looking For A CDMO In Drug Substance Utilization

  Optimize drug substance use during fill/finish. Learn how advanced line configurations and 100% non-destructive weight checks mitigate process drift, protect therapeutics, and prevent product loss.

• Stainless Steel Needles: Quantifying Cobalt Risk For EU Regulation

  Learn how a partner who is committed to ensuring the safety of medical devices by mitigating the risk of chemical interaction with drugs is crucial for navigating the regulatory pathway to approval.

• Improve Solubility And Spray Drying Throughput For Brick Dust Compounds

  This paper presents three approaches to address poor solubility in organic solvents for spray drying as well as case studies outlining their successful application during development.

• PHI And Medical Devices: What Device Manufacturers Need To Know

  Connected medical devices must treat Protected Health Information (PHI) protection as integral to patient safety and compliance. Understand the data flows and HIPAA requirements to design security.

• Pharmaceutical Nanotechnology: What To Know

  Here is what you need to know about the key advantages that pharmaceutical nanotechnology provides in improving drug efficacy and decreasing adverse reactions.

• Sustainability Considerations For Drug Delivery Device End-To-End Solutions

  Learn how to address the gradual unlinking of economic activity from the consumption of finite resources and the removal of waste to support and help prevent a global climate catastrophe.

• Overcoming The Challenge Of Maintaining Sterility At Low Temperature Storage

  Learn about a biotech company with a recently approved gene therapy product that needed to select a packaging solution to meet their needs for storage at low temperatures and still get to market quickly.

• De-Risking The Transition From Vial To Drug-Device Combination Product

  When transitioning from a vial to a combination product system, the best approach is to have a holistic de-risk strategy with an intentional focus on the patient, the plan, and the product.

• How A Flexible Approach To Autoinjector Assembly Can Be Advantageous

  Examine how a flexible, scalable, and efficient solution for the assembly of autoinjectors can help you stay ahead of the competition and meet the demands of an ever-changing industry.