ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• FAQs On The Revised EU GMP Annex 1: Volume 3

  The EU GMP Annex 1 revision, effective August 2023, requires a detailed Contamination Control Strategy. Learn how it impacts global manufacturers, RABS use, and personnel procedures.

• Design Success Combined With Expertise In Testing And Raw Material Selection

  Learn more about improvements and optimized benefits across the packaging attributes required for performance, quality, and safety of the packaging and delivery of lyophilized drug products.

• Achieving New Heights By Expanding Services, Talent, And Facilities

  As you aim to reduce costs and ensure on-time delivery, discover the opportunities for drug formulation and commercial supply that can advance your therapy to the clinic and beyond.

• Long-Term Container Closure Integrity Testing Of Vial-Stopper-Seal Combinations

  The study was designed to investigate CCI over a period of 24 months at ambient, ultra-low and cryogenic temperatures for serum-stopper samples and at ambient temperature for lyo-stopper samples.

• Combining Patient Centricity And Commercial Viability In Pediatric Product Development

  Medication acceptance and adherence are critical concerns in pediatric populations due to these patients’ rapid anatomical and physiological development.

• Maximize Global Regulatory Collaboration

  When marketing a combination product globally, pharmaceutical manufacturers and drug delivery technology providers must have a collaborative infrastructure based on strategic alignment, proactive regulatory awareness, lifecycle support, and continuous improvement globally.

• Establishing And Safeguarding Shelf Life In Combination Products

  Establishing combination product shelf life requires aligning stability. Holistic, data-driven stability studies ensure product function, safety, and label claims through the entire supply chain.

• Nasal Inhalation Delivery – An Introduction Guide

  Unlock the potential of nasal inhalation for delivering active pharmaceutical ingredients by exploring the benefits of both liquid and dry powder formulations as companies drive innovation in the field.

• 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.

• 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.