PHARMA ONLINE WHITE PAPERS

• Safety, Containment, And Analysis Of Highly Potent Compounds

  Explore a comprehensive overview of the challenges, requirements, and best practices for safely working with highly potent compounds in drug development and manufacturing.

• Critical Considerations For Buffer Preparation

  8/7/2023

  Learn about the steps of buffer development, supply approach and strategy selection, choosing between in-house and outsourcing buffer activities, and other related buffer use topics.

• Best Practices In Commissioning And Qualification

  7/5/2024

  An integrated approach to C&Q ensures coordination and synchronization between commissioning and qualification activities, enhancing both regulatory compliance and product safety.

• Eliminating USP <88> In Vivo Animal Bioreactivity Testing For Polymer Characterization

  8/25/2023

  There has been growing awareness about the environmental and ethical implications of plastics used in bioprocessing. The time for a shift to well-studied, proven in vitro cytotoxicity testing is now.

• ICH Q12 Implementation: Regulatory Intelligence And PACM Agility

  7/9/2024

  Here, we outline a practical framework designed to assist companies in implementing ICH Q12 from day one, enabling them to realize its benefits early on and paving the way for continuous improvement.

• Nasal Vaccine Development, Manufacturing, And Device Selection

  7/11/2023

  When developing a nasal delivery program, a partner with experience in development and manufacturing techniques who can see a program through small-scale clinical to commercial supply is crucial.