ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Minimizing API Supply Chain Risks

  Partnering with an API CMO can help you navigate challenges you may encounter, ensuring you are using the best quality practices and minimizing delays in getting those medicines to market.

• Ready-To-Use Cartridges: Ensuring Compatibility For GLP-1-Based Drugs

  Ready-to-use cartridges for GLP-1 applications offer safe, reliable self-administration. See how they can minimize complexities and better align with the stringent demands of modern manufacturing.

• Build A Vial-Stopper Combination Suitable For Drug Product Storage At -80°C

  This study worked to determine if the chosen vial-stopper-seal combination will remain integral while frozen at -80°C, under studied conditions, when the appropriate materials, processing, and sealing conditions are applied.

• A New Framework For Identifying Nitrosamine Risks And Derisking Products

  Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.

• Expanding Home-Based Care With A Next-Gen On-Body Delivery System

  As on-body delivery systems (OBDSs) enable the shift to patient-centric treatment, manufacturers must optimize the device and therapy formulation to minimize the risks and increase adherence.

• Building Sustainability Into Medical Devices

  Medical device waste is a growing problem in the pharmaceutical industry. Learn how to navigate the balance between sustainability and factors like performance, safety, and regulatory compliance.

• Addressing Glass Particulates In Injectable Drug Formulations

  Learn how a new vial design that is capable of reducing the propensity for glass particulate generation on filling lines is enabling a significant, positive impact on product quality and safety.

• Contract Design And Development Vs. In-House: Finding The Best Fit

  Outsourcing medical device R&D to Contract Development Organizations (CDOs) aids innovation, scales resources, and overcomes constraints. Strategic evaluation ensures successful partnerships.

• The Role Of Psychological Principles In Med Device Training Design

  Explore how psychological principles can shape the design of medical device training and the significance of these principles in developing an effective training protocol for new medical device users.

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

  The revised GMP Annex 1 guidelines emphasize quality risk management, enhanced environmental monitoring, and data integrity, which aim to minimize contamination and ensure patient safety.